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A.History and development
ICON public limited company (“ICON plc”) is a contract research organization (“CRO”), founded in Dublin, Ireland in 1990. For over thirty years we have grown significantly to become a global provider of outsourced development and services to pharmaceutical, biotechnology, medical device and government and public health organizations. Our mission is to improve the lives of patients by accelerating the development of our customers’ drugs and devices through innovative solutions.
We are a public limited company in Ireland and operate under the Irish Companies Acts. Our principal executive office is located at: South County Business Park, Leopardstown, Dublin 18, Republic of Ireland. The contact telephone number of this office is +353 1 2912000. Our website is www.iconplc.com. Additionally, the SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. The information contained on any website referenced herein is not incorporated by reference.
Our service offering includes clinical development, functional outsourcing and laboratory services. Our clinical development services include all phases of development (Phases I-IV), peri and post approval, data solutions and site and patient access services. Our laboratory services include a range of high value testing services, including bio-analytical, biomarker, vaccine, good manufacturing practice (“GMP”) and central laboratory services. We also offer full-service and functional service partnerships to our customers.
Since ICON was founded, the Company has expanded through organic growth, together with a number of strategic acquisitions to enhance its expertise and capabilities in certain areas of the clinical development process and to broaden the service portfolio and add scale to existing services. Recent investments, which continue to strengthen our service offerings to meet the needs of our customers include:
On August 19, 2024, the Company acquired the KCR S.A Group (“KCR”), a CRO offering full service and functional services provision (‘FSP’) clinical trial services. On January 9, 2024, the Company acquired HumanFirst, Inc. (“HumanFirst”), a life sciences technology company.
On October 2, 2023, the Company acquired 100% of the equity of BioTel Research, LLC which comprised the business formerly known as Philips Pharma Solutions, a leading provider of medical imaging and cardiac safety monitoring services. On April 20, 2023, the Company completed the purchase of the majority investor's 51% voting share capital of Oncacare Limited (such that Oncacare and its subsidiaries became wholly-owned subsidiaries of the ICON Group), a global network of oncology research sites that provide a unique patient recruitment and delivery solution for the clinical research industry.
With approximately 40,100 employees across the globe, ICON has established relationships with a majority of the world’s top pharmaceutical and biotech companies. We believe the Company has the expertise, technology, and data assets to lead the industry into a new paradigm for bringing clinical research to more patients and enabling expanded capabilities for customers.
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*Revenue figures for 2023 and 2024 have been adjusted for the Restatement.
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Changes in Board of Directors composition & Executive Leadership
On September 4, 2025, the Company announced that Chief Executive Officer (“CEO”), Dr. Steve Cutler, would retire from his role as CEO effective October 1, 2025 and Mr. Barry Balfe, ICON's Chief Operating Officer (“COO”), would succeed Dr. Cutler on that date. Mr. Balfe was also appointed to the Board of Directors effective September 3, 2025. Dr. Cutler resigned from the Board effective May 21, 2026.
On May 27, 2026 the Company announced, that Mr. Kevin Egan and Mr. Jeff Elliott will join the Board of Directors with effect from June 1, 2026.
Share repurchase program
On February 18, 2025, the Company's Board of Directors authorized an additional share repurchase program under which the Company may repurchase up to $750.0 million of the outstanding ordinary shares of the Company by way of redemption. On July 22, 2025, the Company's Board of Directors authorized a further additional repurchase program under which the Company could repurchase up to $500.0 million of the outstanding ordinary shares of the Company by way of redemption.
During the year ended December 31, 2025, 4,504,330 ordinary shares were redeemed by the Company at an average price of $166.51 per share for a total consideration of $750.0 million. As of December 31, 2025, the Company has remaining authorization (which includes unutilized amounts from previous authorizations) to repurchase up to $750.0 million of ordinary shares under the repurchase program.
The New Notes
On May 8, 2024, ICON Investments Six Designated Activity Company (the “Issuer”), a wholly-owned subsidiary of ICON plc, issued $2 billion senior secured notes (the “New Notes”). The New Notes were issued in aggregate principal amounts of: $750.0 million 5.809% Senior Secured Notes due 2027 (the “2027 Notes”), $750 million 5.849% Senior Secured Notes due 2029 (the “2029 Notes”) and $500.0 million 6.000% Senior Secured Notes due 2034 (the “2034 Notes”). The proceeds from the issuance were used to repay a portion of the senior secured term loan outstanding under the Senior Secured Credit Facilities and to pay fees, costs and expenses related to the offering. On July 10, 2024, the New Notes were admitted to the Official List (the “Official List”) of The International Stock Exchange (the “Exchange”).
The Senior Secured Credit Facility
On July 1, 2021, the Company completed the acquisition of PRA by means of a merger whereby Indigo Merger Sub, Inc., a Delaware corporation and subsidiary of ICON, merged with and into PRA Health Sciences, Inc., the parent of PRA Health Sciences (the “Acquisition” and the “Merger”). Upon completion of the Acquisition, PRA became a wholly owned subsidiary within the ICON Group. In conjunction with the completion of the Merger, on July 1, 2021, ICON entered into a credit agreement (the “Credit Agreement”) providing for a senior secured term loan facility of $5,515.0 million and a senior secured revolving loan facility in an initial aggregate principal amount of $300 million (the “Senior Secured Credit Facilities”). The proceeds of the senior secured term loan facility were used to repay the outstanding amount of (i) PRA’s existing credit facilities and (ii) the Company's private placement notes outstanding and fund, in part, the Merger. The Senior Secured Credit Facilities will mature in July 1, 2028 (The senior secured revolving loan facility's original maturity was July 1, 2026; this was extended to July 1, 2028 as of November 26, 2025). As of December 31, 2025, $4,598.3 million of the senior secured term loan facility has been repaid through cash flow ($2,611.5 million) and refinancing ($1,986.8 million - refer to the New Notes above) in the period since the completion of the Merger. At December 31, 2025, $916.7 million was outstanding under the senior secured term loan facility (December 31, 2024: $946.5 million). At December 31, 2025, $nil (December 31, 2024: $nil) was outstanding under the revolving loan facility while there was also $nil (December 31, 2024: $nil) in letters of credit given to landlords to guarantee lease arrangements under the senior secured revolving loan facility.
Repricing and extension – senior secured revolving credit facility
On November 26, 2025, the parties to the Credit Agreement entered into a Fourth Amendment (the “Fourth Amendment”) to reprice and extend the senior secured revolving credit facility.
As a result of the Fourth Amendment, the maturity was extended from a five-year term to a seven-year term ending July 1, 2028. Reflecting the Fourth Amendment, the interest rate margin applicable to borrowings under the revolving loan facility will be, at the option of the borrower, either (i) the applicable base rate plus an applicable margin of 0.35% or 0.00%, based on the Company’s current corporate family rating assigned by S&P of BB (or lower) or BB+ (or higher), respectively, or (ii) Term SOFR plus an applicable margin of 1.35%, 1.00%, 0.75%, 0.55%, or 0.40% based on the Company’s current corporate family rating assigned by S&P of BB (or lower), BB+, BBB-, BBB or BBB+ (or higher), respectively. In addition, lenders under the revolving loan facility are entitled to commitment fees as a percentage of the applicable margin at the time of drawing and utilization fees dependent on the proportion of the facility drawn.
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Repricing - senior secured term loan facility
On March 14, 2024, the parties to the credit agreement entered into a Third Amendment (the “Third Amendment”) in connection with the repricing of the senior secured term loan facility and the senior secured revolving credit facility. The Third Amendment in relation to the senior secured revolving credit facility was further amended by the Fourth Amendment as referred to above.
With respect to the senior secured term loan facility, the repricing culminated in a margin reduction of 25 basis points, from 2.25% (based on the then-current first lien net leverage ratio) to 2.0%; and the elimination of the credit adjustment spread. The combination of the above resulted in an overall reduction of 51 basis points on the senior secured term loan facility (assuming quarterly refixing)
Senior Secured Credit Facilities repayment
During the year ended December 31, 2025, the Company made mandatory principal repayments of $29.8 million (December 31, 2024: mandatory and voluntary principal repayments of $2,304.8 million) of the senior secured term loan facility. There have been no voluntary repayments made during the year ended December 31, 2025. For the year ended December 31, 2024, voluntary repayments resulted in an accelerated charge associated with previously capitalized fees of $16.9 million.
In addition, during the year ended December 31, 2025, the Company drew $50.0 million (December 31, 2024: $318.0 million) of the senior secured revolving loan facility and repaid $50.0 million (December 31, 2024: $373.0 million). At December 31, 2025, $nil was drawn under the senior secured revolving loan facility (December 31, 2024: $nil). Refer to note 13. Bank credit lines, loan facilities and notes in Item 18. Financial Statements included in this Form 20-F for further details on the Company's Senior Secured Credit Facilities.
Bridge Secured Credit Facility
On April 27, 2026, ICON Global Treasury Unlimited Company (the “Bridge Facility Borrower”) entered into a bridge facility credit agreement for an aggregate principal amount of $500 million (the "Bridge Secured Credit Facility"). The proceeds of the Bridge Secured Credit Facility may be used to discharge and repay in full $500 million aggregate principal amount of 2.875% Senior Secured Notes (the “2026 Notes”) issued by a subsidiary of the Group in July 2021. The Bridge Secured Credit Facility will mature on April 26, 2027.
The Borrowings under the Bridge Secured Credit Facility do not amortize and are due at final maturity. The interest rate margin applicable to borrowings under the Bridge Secured Credit Facility is USD Term SOFR plus a fixed calendared applicable margin ranging from 1.00% to 2.25%. At April 30, 2026, the applicable margin was 1.00%.
The Bridge Facility Borrower’s obligations under the Bridge Secured Credit Facility are guaranteed by ICON and the subsidiary guarantors party thereto. The Bridge Secured Credit Facility is secured by a lien on substantially all of the assets (subject to certain exceptions) of ICON, the Bridge Facility Borrower and each of the subsidiary guarantors, and the Bridge Secured Credit Facility will have a first-priority lien on such assets which will rank pari passu with the lien securing ICON’s other first lien secured indebtedness and is subject to other permitted liens. The Company is permitted to make voluntary prepayments under the Bridge Secured Credit Facility without premium or penalty (subject to customary break funding payments).
The Bridge Secured Credit Facility contains customary negative covenants, including, but not limited to, restrictions on the ability of ICON and its subsidiaries to merge and consolidate with other companies, incur indebtedness, grant liens or security interests on assets, pay dividends or make other restricted payments, sell or otherwise transfer assets or enter into transactions with affiliates.
The Bridge Secured Credit Facility provides that, upon the occurrence of certain events of default, the obligations under the credit agreement may be accelerated. Such events of default will include payment defaults to the lenders thereunder, material inaccuracies of representations and warranties, covenant defaults, cross-defaults to other material indebtedness, voluntary and involuntary bankruptcy proceedings, material money judgments, material pension-plan events, change of control and other customary events of default.
Disposal of Symphony Health Solutions Corporation
On May 8, 2026, ICON completed the disposition of Symphony Health Solutions Corporation ("Symphony") pursuant to a merger agreement, by and among HealthVerity, Inc. ("HealthVerity"), Symphony, Pharmaceutical Research Associates, Inc. and HealthVerity Merger Sub, Inc. ("HV Merger Sub"), a wholly owned subsidiary of HealthVerity. Pursuant to the merger agreement, HV Merger Sub merged with and into Symphony, with Symphony surviving the merger as a wholly owned subsidiary of HealthVerity. The consideration payable by HealthVerity in connection with the merger consisted of shares of stock in HealthVerity, subject to customary adjustments as set forth in the merger agreement. In connection with the merger, ICON also purchased additional shares of stock in HealthVerity for an aggregate purchase price of $37.5 million. As a result, ICON holds a minority equity interest in HealthVerity. As of May 8, 2026, the Company’s investment in HealthVerity has been recorded at a carrying value of $nil.
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Waivers to the debt agreements
On April 27, 2026, the parties (senior secured revolving loan facility parties only) to the Credit Agreement entered into a Consent to Credit Agreement pursuant to which the lenders agreed to provide a limited and temporary waiver of the requirement to deliver certain financial statements under the senior secured revolving credit facility. The waiver applied solely for the specified consent period ending May 31, 2026.
On May 18, 2026, the Company launched a consent and waiver to the Credit Agreement in order to request that the requisite lenders thereunder agree to (i) waive the technical default caused by the Company’s late delivery of annual financial statements for the fiscal year ending December 31, 2025, (ii) provide an extension of the delivery of the Company’s annual financial statements for the fiscal year ending December 31, 2025 to July 16, 2026 and (iii) provide an extension of the delivery of the Company’s quarterly financial statements for the fiscal quarter ending March 31, 2026 to July 31, 2026. Consent to the waiver was received on May 22, 2026.
Foreign exchange
The Company prepares its financial statements in United States dollars while the local results of a certain number of our subsidiaries are prepared in currencies other than United States dollars, including, amongst others, the pound sterling and the euro. In addition, the Company's contracts with clients are sometimes denominated in currencies other than the United States dollar. Finally, the Company is exposed to a wider variety of currencies in the expenses line due to most expenses being incurred in the local currencies of where our global operations are based. Accordingly, changes in exchange rates between the United States dollar and those other currencies could have a material adverse effect on the Company’s financial results. In the year ended December 31, 2025, the Company recorded foreign currency losses of $39.3 million in the Consolidated Statements of Operations.
B.Business Overview
ICON is a global provider of outsourced development and commercialization services to pharmaceutical, biotechnology, medical device, and government and public health organizations.
We offer a full range of clinical, consulting and commercial services that range from clinical development strategy, planning and trial design, to full study execution, and post-market commercialization.
ICON provides its services across a range of clinical outsourcing operating models including strategic partnerships, preferred provider, full-service delivery to functional service provision and stand-alone services.
We specialize in the strategic development, management and analysis of programs that support all stages of the clinical development process, from compound selection to Phase I-IV clinical studies. We earn revenue by providing a number of different services to our customers. These services are integral components of the clinical development process and include clinical trial management, consulting, contract staffing, data solutions and laboratory services.
Our vision is to be the partner of choice by delivering industry leading solutions and best in class performance in clinical development. We believe that we are one of a select group of CROs with the expertise and capability to conduct clinical trials in the major therapeutic areas on a global basis and have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated full-service solution. In order to achieve this vision, we continue to invest in technology and data analytics capabilities.
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ICON maintains a sustained focus on research and development. We continue to enhance our portfolio of data solutions and decentralized clinical trial technology through the development of industry-leading technologies and processes to support our clients. ICON is leading the industry transformation through four key levers: transforming clinical trials, site and patient centricity, applied innovation, and seamless, integrated service delivery.
At December 31, 2025, we employed approximately 40,100 employees in 97 locations in 55 countries. During the year ended December 31, 2025, we derived 30.6%, 57.9% and 11.5% of our revenue in the United States, Europe and Rest of World, respectively.
The ICON strategy
We have achieved strong growth since our foundation in 1990, as a global provider of outsourced development and commercialization services to pharmaceutical, biotechnology, medical device and government and public health organizations. We focus our innovation on those factors that are critical to our clients - reducing time to market, reducing cost and increasing quality. Our global team has extensive experience in a broad range of therapeutic areas. ICON has been recognized as one of the world's leading Contract Research Organizations (“CROs”) through a number of high-profile industry awards (see www.iconplc.com/awards).
As our market has evolved, biopharmaceutical companies are tackling productivity challenges, budget constraints and greater demands to demonstrate product value; all of which are placing increased pressure on their revenues and levels of profitability. However, these trends have generally been positive for CROs, as increased outsourcing has been adopted by these companies as they seek to create greater efficiencies in their development processes, convert previously fixed costs to variable, and accelerate time to market for new treatments. We believe innovation in the biopharma sector has been fueled by recent advances in technology, improving scientific profiles of drug targets, and increasing the pipeline of quality assets that can be investigated for further development. This provides biopharma companies an opportunity to strengthen their development pipeline with promising drug candidates, particularly those that are facing challenging patent expiries to their current marketed products.
We believe regulatory and reimbursement pressures will continue to necessitate expansion of late stage (post marketing) research, as increasing requirements to demonstrate the economic value of new treatments are expected. As a result, we believe outcomes and comparative effectiveness research will most likely be required in order to secure on-going product reimbursement. Furthermore, we believe advances in molecular biology and genetics will drive further growth in innovation in the long term, which in turn should create further growth opportunities for both biopharma companies and their outsourced development partners.
We expect that continued outsourcing will be a core strategy of clients in the near and mid-term as they seek to optimize their development operations and adopt models that allow for increased efficiencies. Larger clients were the first to form strategic partnerships with global CROs in an effort to reduce the number of outsource partners with whom they engage and to reduce inefficiencies in their current clinical development models. More recently, we have seen the increasing adoption of this reduced partner model with mid-tier pharmaceutical and biotechnology firms as they also recognize the value of strategic engagement with their development partners. As outsourcing penetration increases, we believe clients may seek a greater level of integration of service offerings from CROs, although some will continue to purchase services on a stand-alone basis. Creating greater connectivity and “seamlessness” between our services and the sharing of real-time clinical, operational and “real world” data with clients will therefore become increasingly important for CROs. ICON will seek to benefit from this increased outsourcing by clients to grow our business by increasing market share with our existing client base and adding new clients within the Phase I-IV outsourced development services market; the aim being to ensure we will be considered for all major Phase I-IV projects.
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Delivery of our mission and strategy is focused on our four strategic pillars, being (i) Patient Access & Engagement (ii) Career Development & Employer of Choice (iii) Enduring Customer Partnerships and (iv) Applied Innovation.
Patient Access & Engagement
ICON has a focused patient, site and data strategy, which is helping us to improve site identification, study placement and patient recruitment and retention.
Accellacare is ICON's global clinical research network offering customers a wide range of stand-alone and integrated solutions at site or in patients' homes as part of decentralized trials. Our patient centric approach accelerates study start-up and increases patient recruitment and retention for the pharmaceutical, biotechnology and medical device industries.
Accellacare In-Home Services takes study visits directly to patients where they live, work, study or play in all phases and therapeutic areas of clinical trials. By bringing trial visits directly to patients, we ease the burden of participating in clinical research to increase patient recruitment and retention. Accellacare In-Home Services has experience in more than 500 clinical trials, tailoring our services to fit each study's specific requirements across more than 55 countries. This cohesive approach is leading to higher patient recruitment and retention rates. Accellacare is also achieving faster study start-up for its customers through efficiencies gained in central process management including budget and contracting, which can otherwise be a source of delay. This combined with a finely tuned feasibility approach allows the network to identify and recruit more patients to studies, in a wide range of therapeutic areas, in a shorter time frame. Accellacare is an important part of the integrated patient, site and data strategy, helping us to improve patient recruitment and retention. Through Accellacare, we are committed to delivering on the promise of patient centricity in clinical research whilst also providing investigators with innovative treatments for their patients with a quality-focused clinical research infrastructure supported by experienced professionals globally.
Accellacare Site Resourcing supports sites to address resource constraints and/or barriers to participation due to a lack of resources. This includes supporting sites with patient recruitment, for example conducting database searches, liaising with referral departments and following up with patients referred from digital patient recruitment campaigns. Accellacare Site Resourcing can also support sites with resources throughout the clinical trial conduct for example, administration support, Electronic Case Report Form (“eCRF”) data entry and query resolution and database lock preparation. The Accellacare Site Resourcing team provides a range of resources from Clinical Research Coordinators, Clinical Research Nurses, Clinical Trial Educators and other specialized resources for example, dieticians required for obesity studies. Accellacare Site Resourcing can deploy resources to site in approximately 20 countries. Through Accellacare Site Resourcing we are committed to delivering highly qualified staff to investigator sites and enable site success in clinical trial participation, delivery and performance.
The Accellacare Site Network encompasses 21 owned/embedded sites across the US, UK and Spain as well as a number of collaboration agreements with other sites. Accellacare offers a quality focused clinical research infrastructure delivering value and benefits to sponsors. Accellacare supports customers with faster start-up and the time from site selection to site initiation visit when compared to other sites. Furthermore, Accellacare achieves on average more patients per site when compared to other sites.
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In 2025, Accellacare Site Network further expanded its site partnerships and focused on enhancing capabilities within its U.S. and UK locations with a continued focus on central nervous system (“CNS”) capabilities and oncology. This included onboarding 27 new investigators across therapeutic areas and a specific increase in oncologists at our Chicago location, providing access to 12 investigators focused on oncology.
The Elite Sites, ICON's dedicated program for top-tier site networks, was designed to offer an infrastructure for those networks who have set themselves apart. These networks have been selected for their high-performance quality, consistency with faster start-up, and ability to meet or exceed recruitment commitments. With the use of ICON’s Elite Site program, the aim is for clients to increase reliability with delivery, reduce site or country footprint, shorten overall study timelines and ultimately get drugs to market faster. ICON Elite Sites have been selected to align with a few key therapeutic areas – oncology, neurosciences, and gastrointestinal / non-alcoholic steatohepatitis (NASH) in which these networks have shown the ability to be true differentiators for our clients and study teams. The ICON Elite Sites program has a global reach, including 5 networks presently, and will continue to expand to best support our clients.
Finding and engaging suitable patients to conduct clinical trials is one of the biggest issues facing the drug development industry today. The performance of investigative sites that do take part in research is uneven, hard to predict and many trials do not meet the initial recruitment goals. The current market challenge in patient enrollment creates an opportunity for ICON to differentiate its service offering and we are working to reduce patient recruitment times through enhanced site and investigator selection based on key performance metrics and through use of our proprietary FIRECREST technology which is used to train and support sites during the development process.
ICON's site networks enhance our ability to enroll patients onto the clinical studies we perform. We have also developed strategic alliances with investigator site groups and healthcare systems in all major global research markets. In partnership with others, we are pioneering patient recruitment solutions that leverage cognitive computing to transform clinical trial matching and allow a data-driven approach to deliver the right patients for trials. One Search is our intuitive, integrated workflow and interrogation tool that enables access to multiple data sources and provides the visualization and tools necessary for optimum site identification based on ICON and industry data of capability, experience and performance. Scoring on enrollment performance, speed of start-up and quality supports better site selection.
Career development and employer of choice
ICON is an award-winning workplace that enables our employees to make a difference to patients’ lives by being part of a world-class clinical research organization that helps deliver new medicines & medical devices that are benefiting patients worldwide.
Our global team of 40,100 employees is united in purpose, working together in an inclusive environment to help solve some of the world’s most complex healthcare challenges. We value integrity, inclusion, collaboration and agility, which together form our ‘Own it’ culture that fosters innovative ideas and a vibrant workplace.
Our success depends on the knowledge, skills and caliber of our people. That’s why we are committed to developing a continuous learning culture – one where we challenge employees with engaging work and where every experience adds to their professional development.
Through our industry leading learning management system, internally developed professional development programs and partnerships with leading academic institutions, employees are encouraged to broaden their scientific, technical and business knowledge.
With a strong emphasis on personal and professional development, ICON equips employees with the skills, knowledge and expertise to navigate and succeed in a dynamic work environment. Employees have access to tools that will help them develop the skills to support their career aspirations. At ICON, we provide growth opportunities for every stage of an employee’s career, empowering them to progress and reach new heights.
From training and development programs to mentorship and coaching, we're committed to helping our employees reach their full potential.
Our Total Reward philosophy is designed to attract, retain, and motivate top talent by offering a holistic and competitive package that reflects our commitment to fairness, equity, and employee wellbeing.
We regularly benchmark our rewards to ensure our compensation and benefits remain competitive in the market. Our goal is to recognize and differentiate based on performance while maintaining a strong value proposition for our employees.
We are committed to pay practices that are transparent, consistent, and free from bias. Our commitment to achieving and maintaining fair pay is central to making ICON a truly inclusive workplace. Our approach ensures that employees are rewarded fairly for their skills, experience, and performance.
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We prioritize the well-being of our employees. Across the world, our programs include comprehensive health benefits, wellness initiatives, and resources that support work-life balance and resilience.
Through this philosophy, we aim to create an environment where employees feel valued, supported, and empowered to thrive both professionally and personally.
Enduring customer partnerships
We continue to focus on expanding and deepening our partnerships with existing customers, while also developing new customer relationships.
Strategic client relationships will increasingly manifest themselves in many different forms. Many of these relationships will require innovative forms of collaboration across ICON service areas and departments and will therefore require increased flexibility to offer services on both a standalone functional basis and as part of a fully integrated service solution. To support this objective, we continue to evolve our collaboration and delivery models, invest in technology that will enable closer data integration across our service areas and enhance our project and program management capabilities.
To meet the evolving needs of both our existing and new clients we continue to enhance our capabilities through both organic service development and targeted acquisitions. In addition, we continue to enhance our scientific and therapeutic expertise to support our customers in specific areas including oncology, orphan and rare diseases, CNS, dermatology, infectious disease and women's health.
ICON has extensive experience in vaccine clinical development for commercial businesses, governments and NGOs. This experience enabled us to play a significant role in the search for vaccines and treatments for COVID-19.
We continue to target growth in under-penetrated CRO market segments. Penetration within medical device companies has lagged that of bio-pharma firms but is beginning to accelerate. EU regulatory reform enacted in 2017 is a further catalyst to growth in this segment as it included stricter requirements to perform clinical evaluations and post-sale surveillance. In early 2020, ICON acquired MedPass which has further enhanced our value offering in this area.
We also invested significantly in our site and patient network (Accellacare), and consider our expertise and offering in this area as one of our strategic pillars.
Applied innovation
At ICON plc, innovation is focused on the factors that are critical to our clients and patients. We develop and integrate technologies that significantly enhance the efficiency and productivity of drug and device development programs, providing transparency across all areas of a study and improving the predictability of outcomes. Our approach combines best-in-class third-party platforms with a suite of differentiated proprietary solutions. Together, these enable smarter trial design and execution, faster and more reliable patient recruitment, and more patient-centric data collection and analysis, including the capture of digital health data directly from patients’ devices.
Operational excellence, quality and delivery
Quality is the foundation of our success. The quality of our work is vital to our mission of bringing better medications to patients around the world. We are committed to maintaining, supporting, checking and improving our quality systems to meet or exceed the quality standards demanded by our clients, patients and regulatory authorities. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Quality project execution underpins all that we do and we have an ongoing focus on developing our people and processes to continue to enhance our service delivery. We also deploy supporting technologies which we believe will enable faster and deeper insights into the quality of trial data.
We are focused on operational excellence across our support functions, and we operate a global business support infrastructure across functions including finance, information technology, facilities, human resources, legal and quality assurance. This enables us to enhance the service levels across these support areas whilst driving down the costs of the service provision.
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Capabilities and service offerings
We believe ICON is the world’s largest pure-play contract research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our focus is on delivering Applied innovation to customers to address the full spectrum of clinical development challenges, not just point-of-service delivery. The synthesis of our experience, expertise, best practices, technology and data provides patient centric processes, commercially optimized for global success, and is driving transformation of trials to improve R&D return on investment.
With an expansive portfolio of integrated clinical, commercialization and consulting services, global presence, depth in therapeutic expertise, and data-driven healthcare technology, we deliver globally scaled expertise & solutions for all customers and patients. Solutions span the Clinical Development lifecycle from compound selection to Phase I-IV clinical studies and post approval outcome research and market access consulting solutions, and can be adapted to suit local trials or large global programs:
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Full service portfolio: Early phase to commercialization
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Industry overview
The CRO industry provides independent product development solutions and services for the pharmaceutical, biotechnology and medical device industries. Companies in these industries outsource services to CROs in order to manage the drug and device development process more efficiently as well as bring drugs, biologics, patent-protected medicinal product and medical devices to market faster to enhance patient well-being and maximize their return on investment. The CRO industry has evolved since the 1970s from a small number of companies that provided limited clinical development services to a larger number of CROs that offer a range of services that encompass the entire research and development process, including pre-clinical development, clinical trials management, clinical data management, study design, bio statistical analyses, post market surveillance, regulatory affairs, central laboratory and market access services. CROs are required to provide services in accordance with good clinical and laboratory practices, as governed by the applicable regulatory authorities.
The CRO industry is highly fragmented, consisting of several hundred small, limited-service providers, medium sized CROs and a small number of large CROs with global operations. Although there are few barriers to entry for small, specialist service providers, we believe there are significant barriers to becoming a CRO with global capabilities and expertise. These barriers include the infrastructure and experience necessary to serve the global demands of clients (sponsors), the ability to recruit sites and patients globally, the management of complex clinical trials, the ability to offer customers a variety of delivery models, broad therapeutic expertise and the development and maintenance of the complex information technology systems required to integrate these capabilities. In recent years, the CRO industry has experienced consolidation, resulting in the emergence of a select group of CROs that have the capital, technical resources, integrated global capabilities, data and expertise to manage the development programs of pharmaceutical, biotechnology and medical device companies. We believe that large and medium-sized pharmaceutical companies are selecting a limited number of CRO service providers with which they deal rather than utilizing many, in order to form strategic partnerships with global CROs in an effort to drive incremental development efficiencies and leverage the scientific and medical expertise. We believe that this trend will continue to concentrate the market share among the larger CROs with a track record of quality, speed, flexibility, responsiveness, global capabilities and access to patients and overall development experience and expertise.
New drug development overview – ethical pharmaceuticals and biologics
Before a new drug or biologic may be marketed, it must undergo extensive testing and regulatory review to determine that it is safe and effective. The following discussion primarily relates to the U.S. FDA approval process for such products. Similar procedures must be followed for product development with other global regulatory agencies. The stages of this development process are as follows:
Preclinical Research “In vitro” (test tube) and animal studies must be conducted in accordance with applicable regulations to establish the relative toxicity of the drug over a wide range of doses and to detect any potential to cause birth defects, affect vital organs, cause mutations or cancer. Many of these tests must be performed before a new investigational therapy can progress into human studies. If results warrant continuing development of the drug or biologic, the sponsor or owner of the asset will file for an Investigational New Drug Application, or (“IND”), which must be approved by the FDA before starting the proposed clinical trials. However, preclinical studies will continue to be conducted in parallel with the clinical trials, some of which can take up to 3 years to complete. ICON can provide expert advice for preclinical programs, but does not conduct preclinical research as a service to its customers.
Clinical trials (approximately 3.5 to 7 years)
Exploratory development
Phase I (approximately 6 months to 1 year) consists of basic safety and tolerability testing in small numbers of human subjects, initially in healthy volunteers, and includes studies which may show the drug is having an effect on the body, if it is safe, how it is affected by other drugs, where it goes in the body, how long it remains active and how it is broken down by and eliminated from the body. After single and multiple dose studies have been conducted, the asset can progress into Phase II, however, Phase I studies will continue to be done to help support the development of the asset in new populations such as children or the elderly.
Phase II (approximately 2 to 3 years) includes basic efficacy and dose-range testing in a limited patient population (usually) 100 to 200 patients to help provide preliminary safety and evidence that the drug is likely to be effective in the target disease. If the Phase II results are satisfactory the sponsor may decide to proceed to Phase III studies.
Confirmatory development
Phase III (2 years or greater) consists of efficacy and safety studies in several hundred to a few thousand patients at multiple investigational sites (hospitals and clinics), often in multiple geographies.
FDA approval, through submission of an IND, is necessary for most clinical trials, regardless of the phase of development. In addition, parallel independent committee approval is also required.
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New Drug Application (“NDA”) or Biologics License Application (“BLA”) Preparation and Submission. Upon completion of Phase III trials, the sponsor assembles the statistically analyzed data from all phases of development into a single large submission along with the Chemistry, Manufacturing and Controls (“CMC”) and preclinical data and the proposed labelling into the NDA, or BLA and submits them for assessment and approval by the relevant division of the FDA.
Expanded Access Programs (“EAPs”). Sometimes an investigational drug may be provided to subjects outside of a clinical trial, also called compassionate use. EAPs refer to the regulated use of a study drug outside of a clinical trial by patients with serious or life-threatening conditions where there is no alternative therapy available. In this context the FDA may allow the sponsor to make the study drug available to a larger number of patients for treatment use.
FDA review and approval of NDA or BLA (1 to 1.5 years). Data from all phases of development is scrutinized to confirm that the applicant company has complied with all applicable regulations, safety and efficacy of the product has been demonstrated, and that the benefit to risk ratio for the drug or biologic is positive for the specific use (or “indication”) under study. The FDA may refuse to accept the NDA or BLA if the application has administrative or content criteria which do not meet FDA standards. The FDA may also deny approval of the drug or biologic product if applicable regulatory requirements are not satisfied, if the drug has not adequately shown to be effective or if there are safety concerns. Often a company will be required to conduct specific studies after the approval of a drug. These are called post approval requirements or commitments.
Post-market surveillance, Phase IV studies and health outcomes. Once approved by the FDA, it requires the drug or biologic license holder to collect and periodically report to them additional safety (and perhaps efficacy) data on the drug or biologic for as long as the manufacturer markets it (post-market surveillance, including pharmacovigilance). If the product is marketed outside the U.S., these reports must include data from all countries in which the drug is sold. Additional studies (Phase III and Phase IV) may be undertaken by the manufacturer after initial approval to find new uses for the drug, to test new dosage formulations, or to confirm selected non-clinical benefits, e.g., increased cost-effectiveness or improved quality of life. Additionally, the FDA and other regulatory agencies may require license holders of drugs or biologics to prepare risk management plans that are aimed at assessing areas of product risk and actively managing such risks throughout the product lifecycle.
Key trends affecting the CRO industry
CROs derive substantially all their revenue from the research and development expenditures of pharmaceutical, biotechnology and medical device companies. We believe that the following trends create further potential growth opportunities for global CROs, although there is no assurance that growth will materialize.
Continued innovation and development of enabling technologies
Innovation driving new drug development activity
New technologies together with improved understanding of disease pathology (driven by scientific advances such as the mapping of the human genome) have increased the number of new drug candidates being investigated in early development. This has greatly broadened the number of biological mechanisms being targeted, which increasingly include rare or orphan diseases that currently have no effective treatments.
These developments should lead to increased activity in both preclinical and Phase I development and in turn lead to more treatments in Phase II-III clinical trials. As the number of trials that need to be performed increases and these trials become focused in indications where finding suitable patients is increasingly challenging, we believe that drug developers will increasingly rely on CROs to manage these trials to leverage their global expertise and to continue to focus their own competencies on drug discovery and sales and marketing of commercialized products.
Decentralized and hybrid trials
Decentralized (“DCT”) and hybrid trials have existed for quite some time, but the coronavirus pandemic accelerated the demand when the pharma industry was challenged to move to remote models to protect patient safety and ensure data integrity for COVID-19 vaccine trials and other ongoing trials. The pandemic provided an opportunity to move many technologies and remote patient care solutions from pilot phase to actively supporting patients and clinical research.
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As an industry, we have an opportunity to make decentralized and hybrid approaches a standard moving forward. The ways the industry has been conducting clinical research in a traditional site-based approach needs to continue to evolve in an effort to implement tools, techniques and processes in everyday research to bring about a more patient-centric approach. Each new element needs to be evaluated to assess the impact for the individual patients and study sites. Recent experiences in the industry have shown:
•Using fewer countries and fewer sites can reduce costs, decrease timelines for start-up and minimize the risk of disruption during and post pandemic.
•Hybrid studies, utilizing digital health, in-home health, and telehealth, can reduce the number and frequency of onsite patient visits and therefore reduce patient burden.
•Home-based patient visits and direct-to-patient contacts can increase patient satisfaction, compliance and retention, providing greater trial resilience.
•Harmonizing data from disparate data sources will provide real-time access and consistent data visibility, helping to improve safety monitoring and enabling the visualization of data trends.
Regulatory easement during the pandemic resulted in a number of positive changes to clinical trial procedures, enabling studies to continue and in some cases progress at a faster pace, and improvements to the process of clinical trial application and IND approvals. Regulatory authorities have been clear that regulatory easement related to the pandemic will not be extended. However, many regulatory authorities have instead released guidance or position statements on the use of DCT elements, such as technology and off-site conduct, more generally in clinical trials, benefiting the patient and healthcare advancement.
Ultimately, our goals are aligned with our customers to increase the speed at which drugs can meet approval guidelines and help treatable populations. By using decentralized tools, technologies and processes, we will reduce the burden on patients, increase satisfaction and provide them with the same standard of care during a virtual or home visit that they would receive in a clinic, thereby fulfilling the promise of clinical research as a care option. While reduced costs may not be seen in the early phase of adoption (in fact investment required may be higher initially due to technology implementation), choosing the right solution for the specific study characteristics has the potential to increase patient recruitment and retention, which can result in reduced overall research costs and quicker time to market. To find the best clinical trial design to suit their needs, sponsors will need to take patient centricity into consideration from the outset and at every step along the way, because what benefits the patient will ultimately benefit the sponsor in outcomes.
New technology enabling more efficient development
Technology innovation is playing an increasingly important role in helping to support more efficient drug development. Leveraging differentiated technology solutions and data collaborations drives better execution in clinical trials. Larger CROs have been at the forefront of this innovation developing technology solutions that support the integration of trial data across multiple systems, data repositories that enable sponsors to get real-time clinical insights on the performance of their drugs and tools that support better trial designs and operation.
The emergence of modern healthcare technologies (“mHealth”) that build on the global prevalence of mobile and digital technologies also have an influence on drug development. It is now possible to capture health data using mobile devices and wearables. This enables sponsors to gather new clinical and “real-world” patient insights and will also be used to enhance patient engagement and adherence throughout the development process. As these devices mature it will also be possible to complete more “decentralized and hybrid trials” based on remote monitoring of patients in their home environment which may drive further efficiencies in the trial process.
Social media is also an important platform for life sciences companies to strengthen patient engagement programs and collaborate with other stakeholders in the healthcare system. Many patients with specific diseases are forming patient groups and actively collaborating using social media. These groups represent an important potential source of patients for new clinical studies but can also provide valuable insights into effectiveness and safety of new treatments.
As the influence of technology on drug development grows, it broadens the potential number of partners that CROs will work with in the future.
Expanded use of new patient data sources
Pharmaceutical companies are looking to access a variety of new healthcare data sources containing medical and prescribing records to help improve development programs and to get better evidence of the value their treatments are bringing to patients once they are launched in the market. The larger global CROs have significant data management experience which can be leveraged to support these efforts and have invested in analytics capabilities to help deliver better insights for customers during the product lifecycle. Global CROs are also forging collaborations to access specific data sets that can provide further patient insights to support better matching of patients and sites to the clinical trial process.
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Improving productivity and operating efficiencies
Continuing focus on productivity within research and development programs
Pharmaceutical and biotechnology companies continue to seek ways to improve the productivity and overall efficiency of their development efforts and increasingly see the use of CROs as a strategic partner in these efforts. They are leveraging the expertise of CROs to help identify the most promising drug candidates in early development and discontinue developing those that have safety issues, limited efficacy or that will have significant reimbursement challenges. These companies are also initiating programs to drive more efficiency in their development programs. One example of this has been the efforts to achieve a more seamless transition across development phases, particularly across Phase I-III trials. In parallel, regulatory initiatives such as the 21st Century Cures Act and the emergence of clinical trial techniques such as adaptive trial design, risk based clinical trial monitoring, decentralized and hybrid trials are enhancing development, allowing effective treatments to get to patients quicker at reduced development costs.
Cost containment pressures
Over the past several years, drug companies have sought more efficient ways of conducting business due to margin pressures stemming from patent expirations of their commercialized products, greater acceptance of generic drugs, pricing pressures caused by the impact of managed care, purchasing alliances and regulatory consideration of the economic benefit of new drugs. Consequently, drug companies are centralizing research and development, streamlining their internal structures and outsourcing certain functions to CROs, thereby converting previously fixed costs to variable costs. Larger companies (and more recently medium sized companies) are actively entering into strategic partnerships with a limited number of CROs in an effort to drive increased efficiencies. The CRO industry and, in particular, large CROs with global capabilities, considerable scientific knowledge and expertise are often able to perform the needed services with greater focus and at a lower cost than the client could perform internally, although CRO companies themselves are facing increased cost containment pressures as drug companies seek to further reduce their cost base.
Global trends influencing the CRO industry
Pressure to accelerate time to markets and globalization of the marketplace
Reducing product development time maximizes the client’s potential period of patent exclusivity, which in turn maximizes potential economic returns, and delivers access to critical and innovative medicines to patients in the market faster. We believe that clients are increasingly using CROs that have the appropriate expertise and innovation to improve the speed of product development to assist them in not only improving economic returns, but achieving their goals in reaching a broader patient population as quickly as possible. In addition, applying for regulatory approval in multiple markets and for multiple indications simultaneously, rather than sequentially, reduces product development time and thereby maximizes economic returns. We believe that CROs with global capabilities, considerable knowledge and experience in a broad range of therapeutic areas are key resources to support a global regulatory approval strategy. Alongside this, the increasing need to access pools of new patients is leading to the conduct of clinical trials in new “emerging regions” such as Eastern Europe, Latin America, Asia-Pacific and South America. We believe that having access to both traditional and emerging clinical research markets gives global CROs a competitive advantage.
Progress within the biotechnology sector
The nature of the drugs being developed is continuing to change. Biotechnology is enabling the development of targeted drugs with diagnostic tests to determine whether a drug will be effective given a patient’s genomic profile. An increasing proportion of research and development expenditure is being spent on the development of highly technical drugs to treat very specific therapeutic areas in sectors of unmet medical need. Much of this discovery expertise is found in biotechnology firms. We believe that it is to these organizations that the large pharmaceutical companies will look for an increasing proportion of their innovation, and consequently, new drug pipelines. Whether it is through licensing agreements, joint ventures or equity investment, we believe we may see the emergence of more strategic relationships between small discovery firms and the larger pharmaceutical groups. As the majority of these biotechnology companies do not have a clinical development infrastructure, we believe that the services offered by CROs will continue to be in demand from such companies providing they have the necessary funding.
Increasing number of large long-term studies and an increasing requirement to show the economic value of new treatments
We believe that to establish competitive claims and demonstrate product value, to obtain reimbursement authorization from bodies such as the FDA in the US, and the National Institute for Health and Clinical Excellence in the UK, and to encourage drug prescription by physicians in some large and competitive categories, more clients need to conduct outcome studies to demonstrate, for example, that mortality rates are reduced by certain drugs. To verify such outcomes, very large patient numbers are required, and they must be monitored over long time periods. We believe that as these types of studies increase there will be a commensurate increase in demand for the services of CROs who have the ability to quickly assemble large patient populations, globally if necessary, to manage this complex process throughout its duration.
The rising costs of healthcare in most developed countries also means there is an increasing pressure to show that new medical treatments are more cost effective and deliver better patient outcomes than existing treatment regimes. This also means that sponsors need to increasingly generate outcome data both as part of the product approval submissions and as part of post-approval research programs. This is creating opportunities for CROs who can offer support in developing and interpreting this data.
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A focus on long-term product safety
The clinical trial approval process can only detect major and common adverse side effects of drugs; less common but no less serious side effects may only become apparent after many years of use. As a result, there is an increase in the number of drugs given “conditional approvals” where further ‘post-approval’ studies are being mandated. In addition, prudent sponsors undertake similar studies to detect early warning signs of any potential problems with their products. Such studies may take the form of prospective long-term safety studies, simpler observational studies or registries where patients meeting specific criteria for disease or drug use are followed for long periods to detect any safety issues. CROs are well positioned to perform these studies on behalf of sponsors.
Increasing regulatory demands
Regulatory agencies increasingly require more data to support new drug approvals and are seeking more evidence that new drugs are safer and more effective than existing products. As a result, the complexity of clinical trials, the number of procedures required to be conducted in these trials and the size of regulatory submissions are driving the amount of data collected on clinical trials on average, and as a result, the demand for services provided by CROs.
ICON Cares
Our mission is to improve the lives of patients by accelerating the development of our customers’ drugs and devices through innovative solutions. We are passionate about providing innovative solutions for customers. ICON is a values-driven company. We focus on agility, collaboration, inclusion and integrity in our work and interactions with our colleagues, suppliers, customers and patients. We are advancing clinical research while offering customers broader and deeper experience, scale, and focus, complemented by continuity of delivery and speed to market. Our business model is described in the preceding sections. Consistent with our values, we seek to not only operate in compliance with applicable laws but also to positively influence our global workforce, the communities that we operate in, the environment and society as a whole. Doing so makes us a stronger, more resilient organization by every measure.
Our core values underpin our mission and drive a culture and mind-set of ownership at ICON. “Own it at ICON”, is a statement of values that has remained at the very heart of ICON’s culture, encouraging our people to seize the opportunity and bring flexibility, innovation, and determination to every situation. We believe our culture of ownership personifies who we are as a company — it also helps us apply our expertise, collaborate to get things done, and succeed at our mission. Our values also underpin how we work together to deliver on our mission to improve the lives of patients by accelerating the development of our customers’ drugs and devices through innovative solutions. These values and our Code of Ethical Conduct, which underpins these values, form the core of what we do, and how we do it. It applies to all of our officers, directors, employees, consultants and agents globally. All employees and temporary workers are mandated to complete annual global ethics training and confirm they have read and understood the Code of Ethical Conduct.
At ICON, we care about conducting business sustainably. We care about our people, patients, and the communities in which we live. We care about doing the right thing and we are committed to working to the highest ethical standards and demonstrating our commitment to honesty, transparency, and quality. As a testament to our commitment, we launched our “ICON Cares” program at the start of 2023 which incorporates all our Environment, Social and Governance (“ESG”) initiatives into one program. ICON’s Environment, Social, and Governance Committee (“ESG Committee”) brings together all these initiatives and efforts under one umbrella to ensure consistency, enhance monitoring, reveal areas for development and facilitate reporting to the Board.
The Nominating, Sustainability, and Governance Committee of the ICON plc Board has oversight responsibilities in respect to ESG-related strategies and initiatives. The Chief Administrative Officer and General Counsel (“CAO”) chairs the ESG Committee and reports on ESG matters to the Nominating, Sustainability and Governance Committee regularly and reports to the Board at least annually whilst also providing periodic ESG updates to the executive leadership team. ICON’s ESG program office reports to the CAO and delivers centralized reporting and tracking of ESG initiatives. The Audit Committee has oversight responsibilities in respect to ESG-related reporting in the ICON financial statements. The Chief Financial Officer (“CFO”) reports to the Audit Committee on ESG-related reporting matters.
The ESG Committee is focused on developing our strategy and initiatives relating to the environment, social matters, health and safety, community engagement, corporate governance, sustainability, and other public policy matters relevant to the Company. The ESG Committee is a cross-functional management committee of the Company including representation from facilities, health and safety, corporate communications, finance, legal, investor relations, procurement, commercial, marketing, and human resources departments. The Committee meets regularly to assist and support executive management and the Board and its committees in:
•determining and setting the strategy relating to ESG matters;
•developing, implementing and monitoring initiatives and policies based on that strategy;
•managing ESG related impacts, risks and opportunities; and
•communicating these strategies, initiatives, and their results.
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We are committed to building and developing our ESG strategies and reporting. In 2020 we launched our ESG page on the ICON website and have an internal ICON Cares ESG page on our MyICON intranet portal to engage with our employees and provide information and updates relating to ESG matters and our commitment to sustainability. In 2021, as a testament to our commitment to managing ICON responsibly and sustainably, we became a participant in the United Nations Global Compact (“UNGC”), a set of Ten Principles covering the areas of human rights, labor, environment, and anti-corruption. In our 2024 ESG report, released in 2025, we reported under the Global Reporting Initiative (“GRI, 2021”) standards, the International Financial Reporting Standards (“IFRS”) S2 index and the Sustainability Accounting Standards Board (“SASB”) index. The report also outlines several ways in which ICON contributes to selected 2030 United Nations Sustainable Development Goals (“SDGs”) and associated targets. The ICON Cares Report summarizes our current policies, priorities, commitments, achievements, and progress in respect to ESG matters. In 2026, ICON was awarded a Platinum medal by EcoVadis, achieving a score of 87/100. This represents an improvement on the Silver medal and score of 72/100 received in 2025 in recognition of our environmental, social and governance performance and management efforts across the organization.
The global landscape in respect to regulatory and legislative requirements relating to ESG reporting and disclosure requirements is rapidly evolving, and we are monitoring potential requirements so that we are positioned to adhere to any additional requirements in due course. This includes mandatory reporting under the Corporate Sustainability Reporting Disclosure (“CSRD”) from the EU and the International Financial Reporting Standards (“IFRS”) S2 index.
Building a sustainable future – our commitment to the United Nations Sustainable Development Goals
As a global company, we maintain an ethical and sustainable presence in hundreds of locations worldwide. At its core, ICON’s mission is to improve health and lives. We are also committed to contributing to the 2030 United Nations SDGs and are proud that our work contributes to their advancement.
Our research, our work with customers and patients and our on-the-ground efforts to meet the needs across our communities align with the SDGs. We focus these efforts on a subset of themes where we have identified the greatest opportunity to effect change:
•SDG 3 – Good health and well-being
•SDG 9 – Industry, innovation and infrastructure
•SDG 10 – Reduced inequalities
•SDG 12 – Responsible consumption and production
•SDG 13 – Climate action
•SDG 17 – Partnerships for the goals
Further details on the ways ICON contributes to these SDGs and their targets are set out in our ICON Cares Report.
Environment: Conducting business sustainably
ICON is committed to delivering excellence in care to our communities. To improve our overall sustainability, this commitment means tracking and improving our environmental performance across all business activities. We achieve this by pursuing sustainability strategies that recognize the impact of our operations as a CRO on the environment, addressing greenhouse gas (“GHG”) emissions, energy use, waste generation and procurement-related activities. Our employees, directors, officers, contractors, temporary workers, and suppliers are expected to support our sustainability objectives. Similarly, ICON endeavors to support our customers sustainability objectives.
Our Global Environmental Management Policy and Environmental Management Plan are part of our ICON Cares program for managing environmental sustainability initiatives. The implementation of the policy and plan is led by our facilities team, reporting to our CAO. The CAO is responsible for reporting on the ICON Cares program and environmental initiatives and progress to the ICON executive leadership team and Nominating, Sustainability and Governance Committee and the Board.
ICON established environmental targets in 2019 focused on renewable energy usage and energy consumption reduction. These targets included achieving 100% renewable electricity by 2025 and a 20% reduction in electricity consumption (kWh) by 2030. In 2025, ICON achieved 97% renewable electricity usage. The remaining 3% reflects limitations in procuring credible Energy Attribute Certificates (“EACs”) due to geopolitical disruptions and regional market constraints in certain jurisdictions, specifically Russia, Belarus, Ukraine, Georgia, and Estonia.
In October 2024, the Science Based Target initiative (“SBTi”) validated ICON’s near- and long-term science-based emissions reduction targets. The SBTi has also verified ICON’s net-zero science-based target (“SBT”) by 2050. The SBTi is a corporate climate action organization that enables companies and financial institutions worldwide to play their part in combating the climate crisis. ICON’s SBTi validated targets:
Near-term targets:
•Reduce absolute scope 1 and 2 GHG emissions 61.2% by FY2028 from a FY2019 base year.
•Reduce absolute scope 3 GHG emissions 20.0% by FY2028 from a FY2022 base year.
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Long-term targets:
•Reduce absolute scope 1 and 2 GHG emissions 90.0% by FY2050 from a FY2019 base year.
•Reduce absolute scope 3 GHG emissions 90.0% by FY2050 from a FY2022 base year.
Net-zero target:
•Reach net-zero greenhouse gas emissions across the value chain by FY2050.
We have programs in place to manage and minimize climate impacts of business activities. To continue to improve processes and reduce our environmental impact, we track, calculate, and report our Scope 1, Scope 2 and Scope 3 GHG footprint. We apply the GHG Protocol Corporate Standard, which is the global corporate accounting and reporting standard for calculating carbon emissions. External verification of our 2025 Scope 1, 2 and 3 GHG emissions data is currently in progress. During 2024, we began our 2022 and 2023 Scope 3 emissions footprinting, incorporating this into our annual emissions reporting.
In respect to ICON’s carbon emissions for the year ended 2025, ICON’s combined Scope 1 and 2 GHG emissions have decreased since 2019, and our scope 3 GHG emissions have decreased since 2022.
In 2020, following pandemic-related closures and a reduction in business travel, our Scope 3, business travel GHG emissions declined significantly. Since 2021 up to the year ended 2025, as more normal business travel operations resumed, we have seen an overall increase in our total GHG emissions driven by an increase in business travel (Scope 3).
Moving forward, ICON expects to see further emission reductions relative to revenue and the number of employees due to a reduction in offices, strategic energy efficiency projects and a flexible work policy that allows eligible employees to work from home 40% of the time.
ICON participates annually in the CDP (formerly the Carbon Disclosure Project), a globally recognized platform that enables companies to assess and manage their environmental impacts. For 2025, ICON received a B score from CDP for its Climate Change response on 2024 activity, representing an improvement from the B‑ score received in the prior year.
We are focused on reducing energy use and increasing renewable energy across our global operations as part of our environmental goals. In 2025, 97% of our electricity consumption came from renewable sources, achieved through a combination of switching direct tariffs and purchasing EAC’s. Waste reduction is embedded into our environmental policies and practices and is one of the objectives of ICON’s Environmental Management Policy.
ICON leases most of our offices and facilities, and therefore we work closely with our landlords and leasing agents to implement measures to ensure we operate in an environmentally sustainable manner. In 2025, we continued with our real estate harmonization efforts and aligning ourselves to new working styles & business needs. This resulted in downsizing or closing 19 locations overall, helping to reduce our environmental footprint. Experts from our real estate team factor environmental considerations into decisions around new office locations or building improvements. We have also implemented a series of measures globally to reduce the local footprint of our offices while promoting comfort and efficiency. These include:
•Installing energy-efficient LED lighting.
•Using motion detectors.
•Purchasing recycled office supplies.
•Reducing paper consumption by promoting paperless office processes and defaulting double-sided output.
•Building recycling areas into business centers and kitchens/canteens.
•Planting green spaces to improve internal air quality.
•Selecting building materials and vendors for their low environmental impact.
As part of our onboarding process, we require our suppliers to abide by our Global Supplier Code of Conduct which outlines our expectations around conducting business in a sustainable manner. The code requires suppliers to comply with all applicable environmental laws and regulations and to have systems in place with regards to waste management and sustainable use of resources.
Social: The power of our people
We are dedicated to making a positive impact on the communities where we work and live. Our community efforts are aligned with a broader vision for social impact and we are committed to furthering the United Nations Sustainable Development Goals (“SDGs”).
Our community engagement activities are focused on two core areas:
•Supporting education and building closer ties between industry and academia; and
•Improving the welfare of people in the communities in which we live.
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Supporting education and building closer ties between industry and academia
A core area of community support includes building ties between industry and academia to inspire the next generation of leaders in business and science. To help achieve this, ICON provides university scholarships to students in Ireland and America. An example of one of our partnerships is:
•Partnership with Junior Achievement to inspire schoolchildren. Junior Achievement encourages young people to remain in education and teaches them the skills they need to succeed in a changing world. ICON volunteers take time out of their working day to deliver Junior Achievement programs, teaching primary and secondary-level students valuable business, STEM (Science, Technology, Engineering & Mathematics) and entrepreneurship skills that will serve them throughout their professional lives. Our strong partnership with Junior Achievement Ireland has been in place since 2018 and we continued our Junior Achievement partnership in India for 2025.
Improving the welfare of people in the communities in which we live
Through volunteering, donations and other charitable initiatives, our employees across the world are making a positive difference to their communities. We support causes that are important to our employees and have several programs that support the welfare of people in our local communities.
Since 2012, ICON’s annual employee-nominated charity donation program has supported over 130 charities worldwide, donating $10,000 to each organization. These charities address a range of critical issues, such as fostering a more inclusive society, improving child welfare, and supporting patients battling chronic diseases. The chosen organizations reflect ICON’s corporate mission, align with our ICON Cares program. In 2025, we also donated $20,000 to UNICEF, providing support for its year-round humanitarian relief efforts. Through ICON’s Charity Matching Program, which bolsters our colleagues’ fundraising efforts and fosters partnership across and within teams, 22 organizations were supported during 2025. This program aligns with the ICON Cares social pillar, as well as our company values of integrity, collaboration, agility and inclusion.
Talent and People
Our people are core to our ability to deliver our services and drive better patient outcomes. Through industry-leading talent management practices, a sincere attention to our employees’ needs, well-being and health and safety, we continue to power the potential of together.
At the core of our strategy is our people
People have long been central to our mission to improve the lives of patients by accelerating the development of our customers’ drugs and devices through innovative solutions. We encourage our people to bring flexibility, innovation, and determination to every situation. By doing so, our people can build exciting and rewarding careers, and deliver results to bring life-changing medicines to market and to maintain our success as an industry leader.
Learning and development of our staff is a key focus for us
Our leadership and talent programs contribute to the enhanced retention of our employees, better project deliverables for our customers and the enhanced financial performance of the business.
We aim to be an industry leader where talented people come to do important work and where our employees can shape the future of healthcare, grow their careers, and reach their full potential. We have long held a deep commitment to cultivating strong people practices. This includes competitive total rewards packages along with a focus on continuous learning. We nurture a culture of development and aim to boost engagement by supporting our people’s growth, both personally and professionally. We are dedicated to finding opportunities for our employees to grow and develop.
Our success depends on the knowledge, capabilities, and quality of our people. To improve their skills, we are committed to providing continuous learning. This commitment is underpinned by clearly defined competencies, which offer employees a clear path along which to develop skills and advance their careers.
To support employees at every stage of their career journeys, training and development programs are aimed at advancing scientific, technical, and business knowledge as well as behavioral competencies. Programs include Corporate and Functional Onboarding for all ICON employees; tailored CRA academies; Data Management and Biostats & Programming Academies; a Commercial Skills Academy; a range of project management curricula, therapeutic-focused programs, and People Leader development programs.
We are focused on retaining the best talent by ensuring employees are aware of what career opportunities exist at ICON. We have invested in our career platforms to ensure employees understand the career opportunities that are available across the organization, providing them with a platform in our HR system to share and capture their skills, interests and career aspirations which enables People Leaders and employees to have better conversations on careers as part of our performance management process. This allows us to get a better understanding of the skills that exist today across the organization, within service lines and teams so we can better serve our customers.
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Our People Leader development program focuses on providing our People Leaders with the relevant skills to effectively manage themselves, their team and their business, including leveraging psychometrics to raise awareness of their behavioral preferences and the preference of others. ICON also invests in Harvard Manage Mentor, an online learning platform providing People Leaders with access to learning available at any time with topics ranging from change management, retaining employees and developing employees.
We provide our people with a personalized and flexible learning experience, delivered through a combination of in-person and technology-driven programs that suit their learning styles and can flex to suit their schedules. Through our industry leading Career Hub, ICON employees are encouraged to broaden their scientific, technical, leadership, and business knowledge. By tapping into development programs and partnerships with leading academic institutions, team members can use the hub to develop competencies that advance their careers. We also collaborate with UCD Smurfit School Executive Development to deliver customized leadership development programs for global employees.
As an organization we are keen to hear directly from our employees
To attract and retain the best talent, we must listen and respond to employees’ needs. This extends to every aspect of our work, from recruitment and onboarding, to training, engagement, enablement, and reward. We pursue best-in-class approaches to building employee engagement and these include, among others:
•Comprehensive global employee surveys, which measure how people feel about their work and whether they feel they have the tools to do their jobs well. Feedback from these studies informs detailed action plans at the group, function, and team level.
•Pulse check surveys, which are smaller-scale studies designed to measure employee sentiment on specific topics and initiatives.
•Fostering an environment of inclusion and belonging where everyone is valued.
•Stay interviews to help managers understand why staff stay and to uncover what might put them at risk of departing.
•Skip-level meetings to develop trust and rapport between senior leaders and employees.
Our listening strategy supports our efforts to reduce employee turnover, which we monitor closely through analytics. Qualitative information is collected through formal exit interviews and, where we believe they’ll make an impact, we intervene via retention plans and related efforts.
Employee well-being
ICON’s commitment to improving health and enriching lives extends beyond the work we do with our customers. Employees worldwide have access to tools and resources designed to support all facets of their well-being, from physical to financial to psychological and beyond.
Our global Employee Assistance Program (“EAP”) ensures that all employees, and their families, have access to professional mental health, financial and relationship support on a confidential basis. Employees can also access a wide range of tools, information and support services online in local languages.
Health and safety
At ICON, the health and safety of our employees, customers and clinical trial patients are our most important priorities. We take guidance from global and regional health authorities and governments to protect the safety and welfare of employees, as well as abide by government directives. Our global health and safety management system ensures we deliver on all local and national requirements. Our priority objectives are the safety of our staff, clinical trial patients, protecting the environment, maintaining business continuity, and ensuring all sensitive health and safety data is protected.
We are committed to providing a safe working environment for our people. We achieve this goal by working in ways that protect the safety, health, and welfare of all our employees, clinical trial patients, and visitors. Risk assessment is the basis of the safety management system, and we work to identify, mitigate, and monitor existing and emerging health or environment risks that may be associated with our business activities.
Fair employment practices
We are committed to being a workplace where all employees are included and feel a sense of belonging. As a global, values-driven organization, we acknowledge and celebrate our differences. Respecting viewpoints and experiences is foundational to our interactions with each other and with our patients, customers and suppliers. Moreover, we strive to build teams that reflect the various geographies and communities in which we live and work and the patients we serve.
We have a strong focus on talent management, succession planning and talent development to ensure we work towards building strong talent pipelines with the best candidate appointed, based on a fair and unbiased selection process where merit, experience and performance form the basis for hiring and promotion decisions.
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Establishing a truly inclusive workplace requires offering fair pay. As part of these efforts, we use best-in-class methodology to regularly review salary ranges. We adhere to a pay-for-performance philosophy and framework that enables us to continuously track fair-pay practices and analyze and audit global pay equity on a regular basis. We have structured our pay principles in such a way that individual differences beyond tenure, experience or performance criteria do not factor into how we provide rewards. ICON has invested in organizational design structures, tools and education to uphold these principles.
We are committed to ensuring fair employment practices. For every jurisdiction in which we operate, we act in compliance with relevant laws relating to labor rights and labor relations as well as market competitive benefits. We believe in fair and equal treatment for all our people, without regard to gender, race, ethnicity, sexual orientation, marital status, physical or mental disability, age, pregnancy, veteran status, nationality, religion, or any other legally protected status. We do not tolerate our employees being subjected to physical, sexual, racial, psychological, verbal, or any other form of harassment. We encourage our employees to report any issues of harassment or discrimination. We prohibit retaliation against any employee who rejects, protests, or complains about unlawful discrimination or harassment.
Human rights
ICON is committed to human rights and in 2021, ICON became a participant in the UN Global Compact (“UNGC”), signaling our commitment to uphold the UNGC’s 10 Principles, including those related to human rights across our global operations. Our business model and our policies, including our Global Code of Ethical Conduct and Global Supplier Code of Conduct, are intended to fully comply with applicable human rights legislation in the countries where we operate. Our zero-tolerance policy on forced labor, slavery, and human trafficking is defined clearly in these policies, which are available to employees, suppliers, customers, and the public.
We are opposed to forced labor, slavery, and human trafficking. We will not knowingly support or conduct business with any organization involved in such activities. We do not employ anyone below the minimum employment age in the jurisdictions in which we operate.
Our Global Supplier Code of Conduct incorporates the Pharmaceutical Supply Chain Initiative (“PSCI”) principles for responsible supply chain management, including for labor. Before doing business with ICON, suppliers must certify that they will comply with the ICON Global Supplier Code of Conduct or their own materially equivalent internal code, which includes human rights protections. We perform pre-engagement due diligence on our suppliers, including in relation to labor issues, which we support through periodic re-screening. We hold our suppliers accountable for meeting their contractual obligations. Contract non-compliance can result in termination of the business relationship with the supplier and exclusion from future business.
Ethics and Compliance
ICON’s commitment to ethics and integrity is embedded in our company values. We require all directors, employees, consultants, agents and third parties acting on ICON's behalf to act with integrity and integrate ethical principles into our business practices and culture. ICON’s Global Code of Ethical Conduct (the “Code”) establishes our core principles and standards for honest, fair, and ethical behavior. This Code addresses the core values expected of all personnel in our internal interactions with each other as well as in external dealings with patients, customers, healthcare professionals, regulators, investors, vendors and other third parties.
Our Ethics and Compliance program is designed to protect the interests of the company and its shareholders by preventing, detecting, investigating and responding to potential misconduct and violations.
The Ethics & Compliance team provides day-to-day independent oversight for the program. The team works collaboratively with risk and compliance functions and leadership across the business to align on and optimize its reach and impact. The program is overseen by the CAO, who reports on the program to ICON’s executive leadership team, the Nominating, Sustainability and Governance Committee and the Board. The program supports all functional areas globally and is dedicated to the implementation of standardized global policies, procedures, training, guidance, communications, monitoring, investigations, issue management, assessing compliance-related risk and mitigations, and reporting to ensure the overall compliance program is effectively functioning. Where appropriate, the program also implements regional and/or country specific policies, procedure, training and guidance.
ICON uses Ethics Line, a system for employees and third parties to confidentially report ethics and compliance questions, as well as concerns, and to track reports through follow-up and resolution. An independent company administers this hotline, which is available all hours of every day and can accommodate reports in over 75 languages. These tools also provide visibility into our risks while highlighting opportunities to address them. ICON’s Ethics and Compliance program will continue to grow and evolve in response to changes in our business and in the global business climate.
All personnel are required to complete ethics and compliance training during initial onboarding and complete annual refresher sessions. Training modules explain the channels available for reporting suspected unethical or illegal practices. The training supports our values and our ways of working and incorporates the key principles of our policies and codes and includes interactive scenarios where applicable.
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At ICON, we promote a Speak Up culture that encourages compliance, openness, and accountability without retaliation. The Speak Up Policy aims to support our culture and values and seeks to encourage the prompt reporting or surfacing of concerns or violations about values, ethics or other standards without fear of retaliation. Reported ethics concerns and other ethics and compliance-related data are reported via the CAO to the Board as appropriate.
Anti-bribery and Corruption
ICON is guided by the foundational principle that we do not tolerate bribery or any other form of corruption or fraud. Our anti-bribery and anti-corruption (“ABAC”) program is a core element of our Ethics and Compliance program. ICON and all ICON directors, employees, consultants, agents and all third parties acting on ICON's behalf must act in compliance with international laws and regulations relating to bribery, corruption, and illicit payments, including but not limited to the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010.
ICON maintains the ISO 37001:2016 certification for our Anti-Bribery Management System, which establishes the framework for the controls that prevent, detect and mitigate the risk of bribery. Our program is designed to ensure our compliance with anti-corruption laws, including due diligence, training, policies, procedures, and internal controls.
Bribery and corruption remain a business risk as we conduct our business across the globe and enter partnerships and collaborations. There is no certainty that all employees and third-party business partners (including our vendors, suppliers, agents, contractors, and other partners) will comply with anti-bribery laws. When working with third parties, we are committed to working with only those who embrace high standards of ethical behavior consistent with our own. Bribery and corruption risks are a focus of our third-party diligence and management process. We hold our suppliers accountable for meeting their contractual obligations with ICON, including commitments that are made with regard to our Global Supplier Code of Conduct and regulatory compliance. Contract non-compliance can result in termination of the business relationship with the supplier and exclusion from future business with ICON.
ICON's internal audit teams conduct ABAC program audits. Internal Audit focuses on testing for compliance and design effectiveness of the overall ABAC program. Internal Audit incorporates an assessment of ABAC measures in audits, as appropriate. In this approach, bribery and corruption risks are incorporated into the risk assessment and scoping process of each audit.
Privacy and Information Security
Data privacy and information security are fundamental to our business and key to retaining customers, building investors’ trust, protecting data subjects who entrust their personal information to us, and complying with global and regional regulations. We recognize and respect that our customers, employees, participants, and all those who do business with us expect that we will protect their personal information in accordance with our legal obligations and policy commitments. ICON´s commitment to privacy and information security is demonstrated through the implementation of robust privacy and information security programs.
ICON’s Global Data Protection program is overseen by the CAO. This program governs ICON’s and its employees’ obligations concerning the processing of personal data. The program consists of a Global Data Protection Officer (“DPO”), a team of privacy lawyers and specialists and corporate policies and procedures regulating how we address our data protection obligations in the countries we operate in, including our obligations under the EU General Data Protection Regulation (“GDPR”) e.g. fulfillment of data subject rights, data protection impact assessments, our obligations to maintain records of processing activities (“ROPAs”) and management of personal data incidents and breaches in accordance with data protection laws. ICON´s Global Data Protection program supports compliance with fundamental data protection principles including transparency, data minimization, accountability and security. ICON has embedded privacy by design considerations in product and process development and implements a robust set of technical and organizational measures to protect personal information processed by ICON.
ICON’s Personal Data Incident and Breach Response Policy and Process governs the management of personal data incidents and breaches within ICON. The policy requires incidents to be reported to ICON’s DPO and Privacy Team, who manage them in collaboration with relevant internal stakeholders (e.g., IT Security, Quality & Compliance), to ensure we comply with our legal and contractual obligations, including our reporting obligations. ICON’s data protection policies and procedures are independently audited as part of ICON maintaining an ISO 27701 certification that it initially achieved in 2023.
Our people and partners play a critical role in safeguarding data. ICON has training in place for all employees and contingent workers on information security and privacy practices so that they understand their responsibilities with respect to data security and privacy. ICON has also established a robust Privacy and Security Champion (“PSC”) network. The PSC network acts as an extension of the Privacy and Information Security teams. In line with the PSC charter, champions provide a key touch point in relevant business units, bolster awareness of ICON’s respective privacy and security programs and provide direct support in response to priorities dictated by ICON’s Privacy and Security Council (chaired by ICON’s DPO and the Vice President of Cyber & Information Security).
For information about our cybersecurity program see Item 16K Cybersecurity.
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Responsible Use of Artificial Intelligence
ICON is committed to the responsible and ethical use of artificial intelligence (“AI”) across our operations. Our approach to AI is guided by a framework of governance, regulatory compliance and respect for client confidentiality and intellectual property. Human judgment and oversight remain integral to the design, deployment and monitoring of AI-enabled solutions. We have structured governance mechanisms and key oversight provisions to comply with the EU AI Act and other laws and support the goals of our AI Ethical Principles.
We have implemented an Artificial Intelligence Governance Policy and a set of AI Ethical Principles which are supported by existing policies relating to data protection and information security, intellectual property, IT governance and supplier management, which apply to the development and use of AI tools.
AI governance is overseen by an AI Governance Committee comprising representatives from IT Digital Operations, Enterprise AI & AI Centre of Excellence (“CoE”) team, Legal, Global Data Protection, Operations and IT Information Security functions and other relevant functions. It operates under the direction of, and reports to, the Chief Information Officer (“CIO”) and the CAO. The AI Screening Committee, a sub-committee of the AI Governance Committee, reviews proposals for AI deployment. AI governance processes are integrated into our overall risk management process, which is monitored by the executive leadership team and reported to the Board. The CIO and CAO provide the Board with AI governance updates as required.
ICON has expanded its IT trainings and digital literacy programs to include AI education, providing training and resources to enhance AI literacy across our workforce in support of responsible AI adoption. We also maintain an internal AI Champions Network to promote best practices across the organization.
Sustainable procurement
ICON maintains policies and processes to support responsible, sustainable, and ethical business practices. Our goal is to source from suppliers whose values align with our own, and who are socially and environmentally responsible and conscious. In 2024 we launched a Sustainable Procurement Policy that outlines our expectations for suppliers relating to sustainability. This policy applies to all suppliers and aims to ensure ICON maintains a responsible and sustainable supply chain.
We manage our suppliers through our Global Procurement department. The onboarding of all new suppliers is completed through a robust centrally managed due diligence process. Environmental sustainability, bribery, and corruption risks are a focus of our third-party assessment and management process.
ICON performs pre-engagement due diligence on our suppliers. This includes screening of sanctions lists, debarment, and adverse media. Suppliers are continuously monitored against sanctions and debarment lists and are periodically re-screened. Suppliers deemed higher risk are subject to enhanced due diligence and controls, which may include periodic training, auditing, and assessments.
As part of our onboarding process, we require our suppliers to abide by our Global Supplier Code of Conduct which incorporates the Pharmaceutical Supply Chain Initiative (“PSCI”) principles for Responsible Supply Chain Management and sets out our standards and expectations regarding:
•Ethics and compliance
•Labor and human rights
•Health and safety
•Environmental stewardship
Our Global Supplier Code of Conduct also outlines channels to report concerns or grievances related to our suppliers, such as our Ethics Line. We operate a strict anti-retaliation policy and expect suppliers to do the same. We hold our suppliers accountable for meeting their contractual obligations, including commitments relating to the Global Supplier Code of Conduct and regulatory compliance. Contract non-compliance can result in termination of the business relationship and exclusion from future business with our company.
To further support the development of our sustainable procurement program, ICON has continued to engage with suppliers via Watershed and EcoVadis to assess data about sustainability maturity and greenhouse gas (GHG) emissions. With this data, we can factor sustainability-related criteria into our supplier selection process and build sustainability into our procurement practices.
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Sales and Marketing
Our marketing strategy is focused on building a differentiated brand, positive perceptions and client consideration for ICON to support our business development efforts to develop deep, durable client relationships with pharmaceutical, biotechnology, medical device, and government and public health organizations. Our marketing activities are coordinated centrally to ensure consistent and differentiated market positioning for ICON and to ensure all marketing aligns with the overall strategic objectives of the business. Our business development teams are located throughout the Americas, Europe and Asia Pacific regions. Business development activities are carried out by account executives with assigned territories and global account directors supporting our large accounts. Specialized business development teams focus on growing each of our business areas. Collectively, our business development team, senior executives and project team leaders share responsibility for client relationships. Our aim is to be a preferred partner to our clients, to help them achieve their goals, and for ICON to gain repeat business and cross-sell additional service lines.
Competition
The CRO industry is fragmented, consisting of many small, niche service providers, a declining number of medium-sized providers and a smaller number of large CROs, including ICON, that are differentiated by the scale of their global operations, breadth of service portfolios and supporting technology infrastructure. The need to conduct complex research and access patients on a global basis is driving market share to these global CROs. When competing for large development programs, ICON competes primarily with IQVIA, PAREXEL, the PPD clinical research services brand of Thermo Fisher Scientific Inc., Fortrea and Syneos Health. In some specific markets, for example biotech and mid-tier pharma, ICON may also compete against mid-tier CROs. Competition also exists for acquisition candidates in addition to competition for customers.
CROs generally compete on the basis of operational experience, the ability to recruit patients on a global basis, the depth of therapeutic and scientific expertise, the strength of project teams, price and increasingly on the ability to apply new innovation that can drive significant time and cost savings throughout the development process. An evolving area of competition is the need to provide services that can help generate the evidence of the economic value of new treatments that payers and regulators require. This requires access to new data sources which includes information to support the identification of suitable investigator sites and patient populations as well as data on the value delivered by new products following marketing approval.
We believe that we compete favorably in all these areas and we continue to invest in our capabilities to ensure that we remain competitive in the future.
Customers
During the year ended December 31, 2025, revenue was earned from a wide range of customers and 24.8% of our revenues were derived from our top five customers, with no one customer individually contributing more than 10% of our revenues during the period. Our largest customer represented a strategic partnership with a large global pharmaceutical company and contributed 7.0% of revenue for the year.
During the year ended December 31, 2024, 25.2% (as restated) of our revenues were derived from our top five customers, with no one customer individually contributing more than 10% of our revenues during the period. Our largest customer represented a strategic partnership with a large global pharmaceutical company and contributed 7.8% (as restated) of revenue for the year ended December 31, 2024.
During the year ended December 31, 2023, 26.7% (as restated) of our revenues were derived from our top five customers, with no one customer individually contributing more than 10% of our revenues during the period. Our largest customer represented a strategic partnership with a large global pharmaceutical company and contributed 8.7% (as restated) of revenue for the year ended December 31, 2023.
The loss of, or a significant decrease in business from one or more of our key customers could have a material adverse impact on our results of operations.
Unsatisfied Performance Obligation
Our unsatisfied performance obligation consists of contracted revenue yet to be earned from projects awarded by clients. At December 31, 2025, we had contracted unsatisfied performance obligations of $14.9 billion (December 31, 2024: $15.9 billion, December 31, 2023: $14.8 billion). We believe that our unsatisfied performance obligation as of any date is not necessarily a meaningful predictor of future results due to the potential for cancellation or delay of the projects included in the unsatisfied performance obligation, and no assurances can be given on the extent to which we will be able to realize this unsatisfied performance obligation as revenue.
Technology Solutions Overview
To provide a cohesive view of our technology landscape, ICON organizes its solutions across four outcome-focused pillars: (i) design smarter trials; (ii) accelerate study start-up; (iii) run efficient operations; and (iv) unlock deeper insights. We also underpin delivery with robust infrastructure, security, governance, and enterprise applications. Key solutions referenced below include both long-standing proprietary platforms and newer AI-enabled capabilities.
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Design smarter trials:
Our solutions help sponsors strengthen protocol design, feasibility, site identification and post-market planning.
•One Search – ICON’s AI-powered site selection tool for rapid identification of high-performing investigative sites, synthesizing multiple data sources with machine learning and rich data visualization to improve start-up and site cycle times, reduce low-performing sites, and increase the percentage of studies meeting planned First Patient In (“FPI”).
•ICONex – Visualizes expert networks and key opinion leaders (“KOLs”), including in rare diseases, to accelerate feasibility planning and protocol development.
•Cassandra – Applies AI/ML to real-world data and FDA / European Medical Agency (“EMA”) post-marketing requirements to predict post-marketing study needs early in development, informing regulatory strategy and commercial planning.
•ICONIK (analytics) and Health Cloud – Core data platforms through which we gather, curate and analyze patient data to inform trial design and enable adaptive and risk-based strategies. Risk-based monitoring reduces overall cost and time to market whilst better protecting patient safety.
•Electronic Medical Record (“EMR”) / Electronic Health Record (“EHR”) enablement – Strategy and partnerships to use electronic medical record data for study design, feasibility, site identification and patient recruitment.
Accelerate study start-up:
Our study start-up portfolio streamlines contracting, site activation, training and document readiness.
•HORIZON – Advanced study start-up solution providing visibility, control and data insights across site activation and startup milestones.
•SmartDraft – AI-powered contract drafting that learns from precedent to accelerate negotiations and reduce friction in global site contracting.
•FIRECREST (Site Portal) – Comprehensive site performance management system for protocol training, document distribution, referrals and communication; includes FIRECREST eConsent for audit-ready, remote and on-site consenting with automatic capture of dates and signatures; integrated with ICON’s Safety Reporting Solution and Site Question Management. FIRECREST includes videos and visual aids to assist in explaining complex scientific concepts and medical terms.
•iSubmit – Intelligent Electronic Trial Master File (“eTMF”) automation that streamlines document filing and compliance checks to improve inspection readiness.
•ICOMaster (eTMF) and third-party eTMF platforms (e.g., Wingspan, PhlexGlobal) – eTMF solutions for secure access, standardized setups and quality-controlled indexing.
•ICON Digital Platform (“IDP”) – An end-to-end patient services platform enabling eConsent, electronic clinical outcome assessments (“eCOA”) (with Mapi Research Trust instruments and translations), tele-visits, eSource, wearables/sensor data, multilingual support and concierge services for patients, caregivers and sites, reducing barriers to participation and enhancing inclusion.
Run efficient operations:
ICON deploys automation, integrated data and flexible study systems to optimize delivery quality, speed and cost.
•Clinical Data Studio – Centralized, automated data platform unifying data from multiple sources to provide a real-time view that improves monitoring, quality and decision-making.
•Risk-Based Monitoring (“RBM”) – Services leveraging near-real-time clinical data to drive prioritized monitoring schedules and adaptive strategies that protect patient safety while reducing cost and time to market.
•Clinical Monitoring – Modern monitoring services aligned with decentralized and hybrid models.
•Flex Advantage – Configurable, web-based Interactive Response Technology / Randomization Trial Supply Management platform delivering the right drug to the right patient at the right time, with inventory management and randomization control.
•Interactive Response Technology – ICON’s interactive response technology for centralized patient randomization, drug inventory management and multi-channel data capture via phone, browser or mobile.
•CARD – Cloud-based platform that simplifies end-of-study clinical archive record distribution to sites with automated file delivery and compliance checks.
•Operational Metrics & Reporting (“OMR” / AI Navigation Assistant) – Generative AI-enabled analytics to transform operational metrics into actionable insights, improving transparency and decision-making across the clinical research process.
•FORWARD+ – AI-enabled resource forecasting and optimization for smoother trial execution.
•Study Start-up Site Contracts – Automated workflows that streamline contract generation and review to accelerate site activation.
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Unlock deeper insights:
We connect, analyze and synthesize clinical and real-world data to support safety oversight and development decision-making.
•Mapi Research Trust (“MRT”) COA – AI-driven outcomes intelligence, updating eCOA libraries in near real-time using natural language processing to support outcomes strategy and trial design.
•Control Tower – Real-time data monitoring and analytics to spot trends and outliers and provide oversight throughout trial conduct.
•Pharmacovigilance & Safety – Services built on Oracle ARGUS, an FDA-regulated, 21 CFR Part 11–compliant platform that generates all required regulatory reports. Augmented by ICON’s risk-management tools (e.g., ORCA Safety business rules engine and Signet benefit–risk intelligence), these solutions enable early signal detection and comprehensive regulatory compliance.
•Population Pharmacokinetics/Pharmacodynamics – Industry-standard pharmacometrics via NONMEM® and PDx-POP® to support modelling and simulation across development.
•Imaging and Cardio Safety – Internally developed Medical Image Review and Analysis system (“MIRA”) and Maestro platforms together with Medidata’s Rave Commercial Imaging to collect, manage and analyze imaging data.
Using Informatics to Provide Accurate and Timely Access to Data
Our informatics strategy provides access to accurate and timely information for sponsors and project teams, enabling management of study data from Electronic Data Capture (“EDC”), patient engagement, EMR/EHR, mobile health, telehealth, wearables and central laboratories. Enhancements to ICONIK have standardized study-specific data derivations for safety monitoring and decision-making, with new visualizations for risk-based, safety and adaptive monitoring.
Decentralized and hybrid trials are enabled through the ICON Digital Platform (“IDP”) with automated data aggregation, real-time access, robotic process automation, and forecasting and prediction algorithms (the “ARCADES” Automated, Real-time, Centralized, Accessible, Discoverable & Scalable Data Enterprise Control Tower). This reduces site and patient burden while providing real-time oversight and integrated, harmonized data flows to sponsor systems.
Underpinning Technology Delivery with Robust IT Infrastructure & Governance
ICON uses a range of enterprise applications to enable global delivery of our services. These include Veeva (SOP document management), Cornerstone (training delivery), ServiceNow (workflow and automation), SailPoint (identity governance), PEGA (safety reporting), Oracle ARGUS (pharmacovigilance), Salesforce (CRM), Medidata (clinical systems), Oracle eBusiness Suite with Hyperion (finance), Workday (HR), and Box, Microsoft 365/Teams/SharePoint for collaboration.
Our IT systems operate from data center hubs in Europe, North America and Asia, using industry-standard networking for secure global connectivity. Mobile staff access systems via secure remote portals. IT expenditure is authorized under strict governance policies requiring senior-level approval and measurable benefits. A global intranet portal serves as the gateway for authorized data and applications and supports company-wide communications.
Laboratory and imaging
ICON’s laboratories operate comprehensive software suites including laboratory information management system (“LIMS”), kit/sample management and web interfaces for online review. Sample Inventory Management System (“SIMS”) provides detailed inventory reporting and drill-down capabilities to expedite sample retrieval at critical junctures. Imaging and cardio safety services are supported by MIRA, Maestro, and Medidata’s Rave Commercial Imaging.
Finance operations and investigator payments
Global finance operations utilize Oracle eBusiness Suite (with Hyperion reporting), while Workday supports human-resource management. Business development and contracting teams use Salesforce CRM. Investigator payments are processed primarily via the Accelerated Payment Entitlements Calculation System (“APECS”) for timely, accurate payments to sites.
Accelerating Clinical Research with AI
ICON operates a dedicated AI Centre of Excellence to accelerate trials, optimize resources and ensure compliance, underpinned by ethical governance and data privacy. Our focus is to find signals quickly, connect information intelligently, predict outcomes and take proactive action to accelerate processes or mitigate risks. Examples include OneView (secure multi-source data integration and interactive dashboards), OneSearch, EXACT™ (CDISC standards automation), ICONex, iSubmit, MRT COA, FORWARD+, SmartDraft, Operational Metrics AI (“OMR”) and CARD. These solutions are complemented by our automation strategy and Robotic Process Automation (“RPA”) capabilities to remove manual bottlenecks.
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Cybersecurity
For information on Cybersecurity refer to Item 16K. Cybersecurity.
ICON continuously evaluates its technology portfolio through formal roadmapping, validation, and post-implementation review. Quality oversight is supported by standard operating procedures, audit trails, and role-based access controls, with periodic training to maintain compliance across staff and vendors. Where appropriate, ICON benchmarks platform performance using cycle-time metrics, protocol deviation rates, and user feedback to identify further optimization opportunities. We also maintain documented business continuity plans and disaster recovery testing across our core platforms, with regular penetration testing and vulnerability management aligned to industry standards. Our supplier management process includes due diligence, data protection assessments, and ongoing service-level monitoring to ensure fitness-for-purpose and regulatory conformity across jurisdictions.
Contractual Arrangements
We are generally awarded projects based upon our responses to requests for proposals received from companies in the pharmaceutical, biotechnology and medical device industries, or through strategic partnership agreements.
Revenues on long term contracts are recognized based on an assessment of progress towards completion. Payment terms usually provide either for payments based on the delivery of certain identified milestones, units delivered or monthly payments, according to a contracted payment schedule over the life of the contract. Where there are changes in the scope of a trial or in the services to be provided by us, a change order or amendment is issued which may result either in an increase or decrease in the contract value. We also contract on a “fee-for-service” or “time and materials” basis.
Contract periods may range from several weeks to several years depending on the nature of the work to be performed. In many cases, an upfront portion of the contract fee is paid at the time the study or trial is started. The balance of the contract fee is generally payable in installments over the study or trial duration and may be based on the completion of certain performance targets or “milestones”, on units delivered, or on a fixed monthly payment schedule. Installment payments may be based on key metrics for example target patient enrollment progress or delivery of the study database.
The progress towards completion for clinical service contracts is measured based on total project costs (fees are therefore inclusive of third party costs). Reimbursable costs include payments to investigators, travel and accommodation costs and various other expenses incurred over the course of the clinical trial which are fully reimbursable by the client. Reimbursable expenses are included within the contract and are invoiced on a monthly basis based on actual expenses incurred. Expenses incurred are determined by reference to activity.
As the currency in which contracts are priced can be different from the currencies in which costs relating to those contracts are incurred, we usually negotiate currency fluctuation clauses in our contracts which allow for price adjustments if changes in the relative value of those currencies exceed predetermined tolerances.
Most of our contracts are terminable immediately by the client with justifiable cause or with 30 to 90 days’ notice without cause. In the event of termination, we are usually entitled to all sums owed for work performed and expenses incurred through the notice of termination and all costs associated with termination of the study. Termination or delay in performance of a contract occurs for various reasons, including, but not limited to, unexpected or undesired results, production problems resulting in shortages of the drug, adverse patient reactions to the drug, the client's decision to de-emphasize a particular trial, inadequate patient enrollment or investigator recruitment.
Risk Management
Our Chief Executive Officer and other members of the executive management team are responsible for day-to-day risk management of the Company and our Board oversees management's activities through both the full Board and its committees. Members of the executive management team are members of ICON’s Quality and Risk Forum, which reviews risk. Our executive management team regularly reports to the Board and its Committees to ensure effective and efficient oversight of our activities and to assist in proper risk management and the ongoing evaluation of management controls. The Board oversees general business and market risk management, our Audit Committee oversees risk management with respect to financial statements, accounting and financial controls, our Compensation and Organization Committee oversees risk management with respect to our compensation plans, policies and procedures and our Nominating, Sustainability and Governance Committee oversees risks relating to ESG matters. Internal audit reports functionally and administratively to our Chief Financial Officer and directly to the Audit Committee. With respect to non-financial risk management, including cybersecurity, legal compliance, privacy, enterprise risk and AI governance, the Board and its Committees receive updates from the appropriate executives on the primary risks facing the Company and the measures the Company is taking to mitigate such risks.
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Government Regulation
The clinical development of new drugs is highly regulated by government agencies. The international standards for the conduct of clinical studies include:
•Good Clinical Practice ("GCP”), which stipulates procedures designed to ensure the quality and integrity of data obtained from clinical testing and to protect the rights and safety of clinical subjects.
•Good Manufacturing Practice (“GMP”) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
•Good Distribution Practice (“GDP”) ensures that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur throughout the distribution process by ensuring that products are appropriately stored, transported and handled.
The U.S. FDA and other national regulators have promulgated regulations and guidelines that pertain to applications to initiate trials of products, the approval and conduct of studies, report and record retention, informed consent, applications for the approval of drugs and post-marketing requirements. Pursuant to these regulations and guidelines, service providers that assume the obligations of a drug sponsor are required to comply with applicable regulations and are subject to regulatory action for failure to comply with such regulations and guidelines. In the United States and Europe, the trend has been in the direction of increased regulation and enforcement by the applicable regulatory authority.
In providing services in the United States, we are obligated to comply with FDA requirements governing such activities. These include ensuring that the study is approved by an appropriate Independent Review Board (“IRB”) and Ethics Committee, obtaining patient informed consents, verifying qualifications of investigators, reporting patients’ adverse reactions to drugs and maintaining thorough and accurate records. We must maintain critical documents for each study for specified periods, and such documents may be reviewed by the study sponsor and the FDA.
The services we provide outside the United States are ultimately subject to similar regulation by the relevant national regulatory authority. In addition, our activities in Europe are in compliance with the European Medicines Agency processes.
We must retain records for each study for specified periods for inspection by the client and by the applicable regulatory authority during audits. If we fail to comply with applicable regulations and guidelines, it could result in a material adverse effect. In addition, our failure to comply with applicable regulations and guidelines, depending on the extent of the failure, could result in fines, debarment, termination or suspension of ongoing research, the disqualification of data or litigation by clients, any of which could also result in a material adverse effect.
Potential Liability and Insurance
The nature of our business exposes us to potential liability including, but not limited to, potential liability for (i) breach of contract or negligence claims by our customers and, (ii) third party (such as patients) claims in respect of our performance of services.
In addition, although we do not believe we are legally responsible for acts of third party investigators (physicians running trials), we could be subject to claims arising as a result of the actions of these investigators.
We try to reduce this potential liability by:
•Seeking contractual indemnification from customers in relation to certain activities. The terms and scope of indemnification varies from customer to customer and project to project and the performance of these indemnities is not secured. As a result, we bear the risk that indemnification may not be relevant or sufficient or that the indemnifying party may not have the financial ability to fulfill its indemnification obligations. This indemnification does not protect us against our own acts or omissions such as our negligence or where our performance does not reach the required contractual, industry or regulatory standard.
•Maintaining worldwide professional liability insurance. While we maintain the types and amounts of insurance we view as customary in the industries and countries in which we operate, there is no guarantee that we will continue to be able to maintain such insurance coverage on terms acceptable to us, if at all, or that the relevant policy will respond and provide cover when we want it to.
We could be materially adversely affected if ICON is required to pay damages or bear the costs of defending or settling any claim which a) is outside the scope of or in excess of a contractual indemnification provision, b) an indemnifying party does not fulfill its indemnification obligations, c) the claim is in excess of the level of our insurance coverage or d) the relevant circumstances are not covered by our insurance policies.
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C.Organizational Structure
Details of the Company’s significant subsidiaries or entities under the Company's control at December 31, 2025 are as follows:
Company Country Group ownership
ICON Clinical Research S.A. Argentina 100%
RPS Research S.A. Argentina 100%
ICON Clinical Research PTY Limited Australia 100%
KCR CRO Pty Ltd Australia 100%
Medpass International Pty Ltd Australia 100%
Pharmaceutical Research Associates Pty Limited Australia 100%
ICON Clinical Research Austria GmbH Austria 100%
RPS Research Austria GmbH Austria 100%
IMP-Logistics Bel, FLLC Belarus 100%
ICON Clinical Research Belgium B.V. Belgium 100%
RPS Bermuda, Ltd. Bermuda 100%
ICON Pesquisas Clínicas Ltda. Brazil 100%
Pharmaceutical Research Associates Ltda. Brazil 100%
RPS do Brasil Serviços de Pesquisas Ltda. Brazil 100%
RPS China Inc. British Virgin Islands 100%
ICON Clinical Research EOOD Bulgaria 100%
KCR CRO Ltd. Bulgaria 100%
Pharmaceutical Research Associates Bulgaria EOOD Bulgaria 100%
3065613 Nova Scotia Company Canada 100%
ICON Clinical Research (Canada) Inc. Canada 100%
Pharmaceutical Research Associates ULC Canada 100%
Services de Recherche Pharmaceutique Srl Canada 100%
Oxford Outcomes LTD. Canada (British Columbia) 100%
ICON Life Sciences Canada Inc. Canada- Ontario 100%
ICON Chile Limitada Chile 100%
PRA Health Sciences Chile SpA Chile 100%
ICON Clinical Research (Beijing No.2) Co., Ltd China 100%
ICON Clinical Research (Beijing) Co., Ltd China 100%
PRA Health Sciences China, Inc. China 100%
PRA Health Sciences Colombia Ltda. Colombia 100%
Research Pharmaceutical Services Costa Rica, LTDA. Costa Rica 100%
ICON Research Ltd. Croatia 100%
Pharm Research Associates Ltd. Croatia 100%
ICON Clinical Research Czech Republic s.r.o. Czech Republic 100%
KCR Czech Republic a.s., (in Liquidation) 2 Czech Republic 100%
DOCS International Nordic Countries A/S Denmark 100%
Pharmaceutical Research Associates Denmark ApS Denmark 100%
ICON Clinical Research Egypt Limited Liability Company Egypt 100%
KCR Baltics OÜ Estonia 100%
RPS Estonia OÜ Estonia 100%
DOCS International Finland Oy Finland 100%
Pharmaceutical Research Associates Finland Oy Finland 100%
ICON Clinical Research S.A.R.L. France 100%
Mapi Research Trust1 France 100%
Oncacare France SAS France 100%
54
Company Country Group ownership
ReSearch Pharmaceutical Services France S.A.S. France 100%
IMP Logistics Georgia LLC Georgia 100%
KCR LLC Georgia 100%
Pharmaceutical Research Associates Georgia LLC Georgia 100%
Averion Europe GmbH i.L (in Liquidation) 3 Germany 100%
ICON Clinical Research Germany GmbH Germany 100%
KCR CRO GmbH Germany 100%
KCR Placement GmbH (in liquidation) Germany 100%
Oncacare (Germany) GmbH Germany 100%
Pharmaceutical Research Associates Greece A.E. Greece 100%
ICON Clinical Research Guatemala, S.A. Guatemala 100%
ICON Clinical Research Hong Kong Limited Hong Kong 100%
PRA Health Sciences (Hong Kong) Limited Hong Kong 100%
ICON Clinical Research Limited Liability Company Hungary 100%
Pharmaceutical Research Associates Hungary Research and Development Ltd. Hungary 100%
RPS Iceland ehf. Iceland 100%
ICON Clinical Research India Private Limited India 100%
Pharmaceutical Research Associates India Private Limited India 100%
Accellacare Limited Ireland 100%
ICON (LR) Limited Ireland 100%
ICON Clinical Global Holdings Unlimited Company Ireland 100%
ICON Clinical Research Holdings (Ireland) Unlimited Company Ireland 100%
ICON Clinical Research Limited Ireland 100%
ICON Clinical Research Property Development (Ireland) Limited Ireland 100%
ICON Clinical Research Property Holdings (Ireland) Limited Ireland 100%
ICON Global Treasury Unlimited Company Ireland 100%
ICON Holdings Clinical Research International Limited Ireland 100%
ICON Holdings Unlimited Company Ireland 100%
ICON Investments Four Unlimited Company (in Liquidation) Ireland 100%
ICON Investments Six Designated Activity Company Ireland 100%
ICON Operational Financing Unlimited Company Ireland 100%
ICON Operational Holdings Unlimited Company Ireland 100%
Oncacare Limited Ireland 100%
ICON Clinical Research Israel Ltd. Israel 100%
Pharmaceutical Research Associates Israel Ltd. Israel 100%
Oncacare Italy S.r.l Italy 100%
Pharmaceutical Research Associates Italy S.r.l. Italy 100%
ICON Clinical Research GK Japan 100%
ICON Investments Limited Jersey 100%
PRA Health Sciences Kenya Limited Kenya 100%
RPS Latvia SIA Latvia 100%
UAB RPS Lithuania Lithuania 100%
ICON Luxembourg S.à r.l. Luxembourg 100%
ICON CRO Malaysia Sdn. Bhd. Malaysia 100%
RPS Malaysia Sdn. Bhd. Malaysia 100%
ICON Clinical Research México, S.A. de C.V. Mexico 100%
Pharmaceutical Research Associates Mexico S. de R.L. de C. V. Mexico 100%
55
Company Country Group ownership
RPS Research México, S. de R.L. de C.V. Mexico 100%
RPS Research Servicios, S. de R.L. de C.V. Mexico 100%
DOCS International B.V. Netherlands 100%
Pharmaceutical Research Associates Group B.V. Netherlands 100%
PRA International Operations B.V. Netherlands 100%
ReSearch Pharmaceutical Services Netherlands B.V. Netherlands 100%
ICON Clinical Research (New Zealand) Limited New Zealand 100%
Pharmaceutical Research Associates New Zealand Limited New Zealand 100%
RPS Research Norway AS Norway 100%
RPS Panama Inc. Panama 100%
ICON Clinical Research Perú S.A. Peru 100%
RPS Perú S.A.C. Peru 100%
ICON Clinical Research Services Philippines, Inc. Philippines 100%
RPS Research Philippines, Inc. Philippines 100%
Curandus Sp z o.o. Poland 100%
ICON Clinical Research Poland Sp z o.o. Poland 100%
KCR Placement Sp z o.o. Poland 100%
KCR S.A. Poland 100%
Pharmaceutical Research Associates Sp. z o.o. Poland 100%
Symphony Clinical Research Sp z.o.o. Poland 100%
PRA International Portugal, Unipessoal, Lda. Portugal 100%
Research Pharmaceutical Services Puerto Rico, Inc. Puerto Rico 100%
ICON Clinical Research S.R.L. Romania 100%
Pharmaceutical Research Associates Romania S.R.L. Romania 100%
ICON Clinical Research (Rus) LLC Russia 100%
Joint Stock Company IMP Logistics Russia 100%
KCR LLC Russia 100%
ICON Clinical doo Beograd Serbia 100%
ICON Clinical Research doo Beograd Serbia 100%
ICON Clinical Research (Pte) Limited Singapore 100%
Mapi Life Sciences Singapore Pte. Ltd. Singapore 100%
Pharmaceutical Research Associates Singapore Pte. Ltd. Singapore 100%
ICON Clinical Research Slovakia, s.r.o. Slovakia 100%
KCR s.r.o. Slovakia 100%
Pharmaceutical Research Associates SK s.r.o. Slovakia 100%
Accellacare South Africa (PTY) LTD South Africa 100%
PRA Pharmaceutical S A (Proprietary) Limited South Africa 100%
RPS Research South Africa (Proprietary) Limited South Africa 100%
ICON Clinical Research Korea Limited South Korea 100%
Mapi Korea Yuhan Hoesa/ Mapi Korea LLC (in Liquidation) South Korea 100%
Pharmaceutical Research Associates Korea Limited South Korea 100%
Accellacare España S.L. Spain 100%
ICON Clinical Research España, S.L. Spain 100%
KCR CRO, S.L.U. Spain 100%
Oncacare (Spain), S.L. Spain 100%
Pharmaceutical Research Associates España, S.A.U. Spain 100%
RPS ReSearch Ibérica, S.L.U. Spain 100%
RPS Spain, S.L. Spain 100%
56
Company Country Group ownership
DOCS International Sweden AB Sweden 100%
PRA International Sweden AB Sweden 100%
DOCS International Switzerland GmbH Switzerland 100%
ICON Clinical Research (Switzerland) GmbH Switzerland 100%
PRA Switzerland AG Switzerland 100%
ICON Clinical Research Taiwan Limited Taiwan 100%
Pharmaceutical Research Associates Taiwan, Inc. Taiwan 100%
ICON Clinical Research (Thailand) Limited Thailand 100%
RPS Research (Thailand) Co., Ltd. Thailand 100%
ICON Ankara Klinik Arastirma Dis Ticaret Anonim Sirketi Turkey 100%
Pra Turkey Sağlik Araştirma Ve Geliştirme Limited Şirketi Turkey 100%
DOCS Ukraine LLC Ukraine 100%
ICON Clinical Research LLC Ukraine 100%
IMP-Logistics Ukraine LLC Ukraine 100%
KCR Ukraine LLC Ukraine 100%
Pharmaceutical Research Associates Ukraine LLC Ukraine 100%
Accellacare UK Limited United Kingdom 100%
Aptiv Solutions (UK) Ltd United Kingdom 100%
DOCS International UK Limited United Kingdom 100%
ICON (LR) Limited United Kingdom 100%
ICON Clinical (UK) Limited United Kingdom 100%
ICON Clinical Research (U.K.) Limited United Kingdom 100%
ICON Clinical Research (U.K.) No. 2 Limited United Kingdom 100%
ICON Clinical Research (U.K.) No. 3 Limited United Kingdom 100%
ICON Clinical Research (U.K.) No. 5 Limited United Kingdom 100%
ICON Clinical Research (U.K.) No. 6 Limited United Kingdom 100%
ICON Clinical Research Holdings (U.K.) Limited United Kingdom 100%
ICON Development Solutions Limited United Kingdom 100%
ICON Investments (UK) Ltd United Kingdom 100%
IMP Logistics UK Limited United Kingdom 100%
KCR CRO Ltd. United Kingdom 100%
Medeval Group Limited United Kingdom 100%
OncaCare (U.K.) Limited United Kingdom 100%
Sterling Synergy Systems Limited United Kingdom 100%
VSK (Kenilworth) Limited United Kingdom 100%
RPS Global S.A. Uruguay 100%
RPS Latin America S.A Uruguay 100%
KCR U.S., Inc. USA - Delaware 100%
ICON Early Phase Services, LLC USA - Texas 100%
ClinStar LLC USA- California 100%
Nextrials, Inc. USA- California 100%
Pharmaceutical Research Associates CIS, LLC USA- California 100%
Pharmaceutical Research Associates Eastern Europe, LLC USA- California 100%
Addplan, Inc. USA- Delaware 100%
Beacon Bioscience, Inc USA- Delaware 100%
C4 MedSolutions, LLC USA- Delaware 100%
Care Innovations, Inc. USA- Delaware 100%
Care Innovations, LLC USA- Delaware 100%
57
Company Country Group ownership
CHC Group, LLC USA- Delaware 100%
CRI NewCo, Inc. USA- Delaware 100%
CRI Worldwide, LLC USA- Delaware 100%
CRN Holdings, LLC USA- Delaware 100%
CRN NORTH AMERICA, LLC USA- Delaware 100%
Global Pharmaceutical Strategies Group, LLC USA- Delaware 100%
ICON Clinical Investments, LLC USA- Delaware 100%
ICON Clinical Research LLC USA- Delaware 100%
ICON Clinical Research, LP USA- Delaware 100%
ICON Laboratory Services, Inc. USA- Delaware 100%
ICON Tennessee, LLC USA- Delaware 100%
ICON US Holdings Inc. USA- Delaware 100%
International Medical Technical Consultants, LLC USA- Delaware 100%
MMMM Consulting, LLC USA- Delaware 100%
MMMM Group, LLC USA- Delaware 100%
MolecularMD Corp. USA- Delaware 100%
Oncacare, Inc. USA- Delaware 100%
Parallel 6, Inc. USA- Delaware 100%
PRA Early Development Research, Inc. USA- Delaware 100%
PRA Health Sciences, Inc. USA- Delaware 100%
PRA Holdings, Inc. USA- Delaware 100%
PRA International, LLC USA- Delaware 100%
PRA Receivables, LLC USA- Delaware 100%
PriceSpective LLC USA- Delaware 100%
PubsHub LLC USA- Delaware 100%
ReSearch Pharmaceutical Services, LLC USA- Delaware 100%
ReSearch Pharmaceutical Services, Inc. USA- Delaware 100%
Roy RPS Holdings LLC USA- Delaware 100%
RPS Global Holdings, LLC USA- Delaware 100%
RPS Parent Holding LLC USA- Delaware 100%
Source Healthcare Analytics, LLC4 USA- Delaware 100%
Sunset Hills, LLC USA- Delaware 100%
Symphony Health Solutions Corporation4 USA- Delaware 100%
Accellacare of Christie Clinic, LLC USA- Illinois 100%
Clinical Resource Network, LLC USA- Illinois 100%
CRI International, LLC USA- New Jersey 100%
DOCS Global, Inc. USA- New Jersey 100%
Managed Care Strategic Solutions, L.L.C. USA- New Jersey 100%
Accellacare of Charlotte, LLC USA- North Carolina 100%
Accellacare of Hickory, LLC USA- North Carolina 100%
Accellacare of Raleigh, LLC USA- North Carolina 100%
Accellacare of Rocky Mount, LLC USA- North Carolina 100%
Accellacare of Salisbury, LLC USA- North Carolina 100%
Accellacare of Wilmington, LLC USA- North Carolina 100%
Accellacare of Winston-Salem, LLC USA- North Carolina 100%
Accellacare US Inc. USA- North Carolina 100%
Complete Healthcare Communications LLC USA- Pennsylvania 100%
Complete Publication Solutions, LLC USA- Pennsylvania 100%
58
Company Country Group ownership
Accellacare of Charleston, LLC USA- South Carolina 100%
Accellacare of Bristol, LLC USA- Tennessee 100%
Lifetree Clinical Research, LC USA- Utah 100%
ICON Government and Public Health Solutions, Inc. USA- Virginia 100%
Pharmaceutical Research Associates, Inc. USA- Virginia 100%
ICON Clinical Research Vietnam LLC Vietnam 100%
1 Mapi Research Trust is an association, its members are ICON Subsidiary entities.
2 KCR Czech Republic a.s. liquidated on January 6, 2026.
3 Averion Europe GmbH i.L liquidated on March 26, 2026.
4 On May 8, 2026, ICON completed the disposition of Symphony Health Solutions Corporation and its subsidiary Source Healthcare Analytics, LLC.
D. Description of Property
Our principal executive offices are located in South County Business Park, Leopardstown, Dublin, Republic of Ireland, where we own an office facility of approximately 15,000 square meters. We also own a property in San Antonio, Texas. We lease all other properties.
We maintain forty-three offices in Europe; eight of our offices are in the UK, six in the Netherlands, three in Spain, two in each of Poland, Hungary, Russia, France, Sweden, and Ireland and one in each of Slovakia, Romania, Belgium, Georgia, Bulgaria, Belarus, Estonia, Germany, Czech Republic, Turkey, Israel, Ukraine, Italy and Latvia. We maintain thirty offices in North America; twenty-eight in the United States, and one in each of Canada and Mexico. We have seventeen offices in Asia; six in China (including one in Hong Kong), three in India, two in each of Japan and Singapore, and one in each of South Korea, Taiwan, Thailand and the Philippines. We have one office in Australia. We have five offices in South America: one in each of Argentina, Brazil, Chile, Colombia and Peru. We maintain one office in South Africa.