About ICON Public
ICON Public Limited Company (ICON plc or ICON) operates as a clinical research organization (CRO). The company is a global provider of outsourced development and commercialization services to pharmaceutical, biotechnology, medical device, and government and public health organizations. The company's service offering includes clinical development, functional outsourcing and laboratory services. The company's clinical development services include all phases of development (Phases I-IV), peri and post approval, data solutions and site and patient access services. The company's laboratory services include a range of high value testing services, including bionanalytical, biomarker, vaccine, good manufacturing practice ('GMP') and central laboratory services. The company also offers full-service and functional service partnerships to its customers. 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 company), a global network of oncology research sites that provide a unique patient recruitment and delivery solution for the clinical research industry. The company offers 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. The company specializes 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. The company earns revenue by providing a number of different services to its customers. Those services are integral components of the clinical development process and include clinical trial management, consulting, contract staffing, data solutions and laboratory services. During the year ended December 31, 2023, the company derived approximately 40.4%, 48.7% and 10.9% of the company's revenue in the United States, Europe, and Rest of World, respectively. The ICON strategy The company's strategic pillars include patient access & engagement; enduring customer partnerships; and healthcare intelligence & applied innovation. Patient Access & Engagement ICON has a focused patient, site and data strategy, which is helping the company 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. The company's 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, the company eases the burden of participating in clinical research to increase patient recruitment, retention and diversity. Accellacare In-Home Services has experience in more than 450 clinical trials, tailoring the company's services to fit each study's specific requirements across more than 50 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 the company to improve patient recruitment and retention. Through Accellacare, the company is 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. The Accellacare Site Network encompasses more than 50 sites across 6 countries covering the United States, Europe and South Africa. 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 is on average 30% faster when compared to other sites. Furthermore, Accellacare achieves an average of 40% more patients per site when compared to other sites. In 2023, Accellacare Site Network optimized its site partnerships and focused on enhancing capabilities within its U.S. locations with a continued focus on Central nervous system (CNS) capabilities. ICON fully acquired the Oncacare site network in April 2023. The company is working to reduce patient recruitment times through enhanced site and investigator selection based on key performance metrics and through use of the company's proprietary FIRECREST technology which is used to train and support sites during the development process. ICON's site networks enhance the company's ability to enroll patients onto the clinical studies the company performs. The company has also developed strategic alliances with investigator site groups and healthcare systems in all major global research markets. In partnership with others, the company is 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 the company's 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. Enduring Customer Partnerships The company continues to focus on expanding and deepening its partnerships with existing customers, while also developing new customer relationships. The company continues to evolve its collaboration and delivery models, invest in technology that will enable closer data integration across the company's service areas, and enhance the company's project and program management capabilities. To meet the evolving needs of both the company's existing and new clients the company continues to enhance its capabilities through both organic service development and targeted acquisitions. In addition, the company continues to enhance its scientific and therapeutic expertise to support the company's 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 the company to play a significant role in the search for vaccines and treatments for COVID-19. Of particular note was the company's work in partnering with Pfizer and BioNTech on their investigational COVID-19 vaccine program - the first to announce positive efficacy results from a Phase 3, late-stage study of a COVID-19 vaccine and to receive Emergency Use Authorization in individuals 16 years of age or older from the U.S. Food and Drug Administration. ICON mobilized a large global team of therapeutic and operational specialists to partner on the implementation of Pfizer's and BioNTech's strategic plan and framework for the monitoring of the trial, which included a high level of remote clinical monitoring and source data verification in addition to on-site monitoring, safeguarding data quality and integrity in the evolving pandemic environment. The team combined the benefits of full service and functional service provider clinical operating models to increase efficiency and ensure rapid study start-up. ICON worked with 153 sites in the U.S., Europe, South Africa and Latin America to ensure the recruitment of more than 44,000 trial participants over a four-month period in late 2020. ICON provided site training, document management and operational support for patient Informed Consent Form review, coordinated eConsent in most countries, and assisted with clinical supply management services. Achieving the unprecedented trial timelines, while maintaining high standards of quality, undertaken in response to the pandemic required collaboration and strong communication between the ICON and sponsor project teams. The company continues 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 the company's value offering in this area. The company also invested significantly in its site and patient network (Accellacare), and considers the company's expertise and offering in this area as one of the company's strategic pillars. Healthcare Intelligence and Applied Innovation Innovation at ICON is focused on the factors that are critical to the company's clients. The company develops integrated technologies to significantly enhance the efficiency and productivity of clients' drug and device development programs, providing true transparency across all areas of a study. ICON is focused on applying innovation that can help the company's customers improve their development outcomes. The company is focusing this innovation in three critical areas: improving clinical trial design and execution; faster and more predictable patient recruitment; and evolving clinical trials to be more patient centric which includes data collection and analysis directly from patient's digital devices. The company's approach to developing solutions to these challenges incorporates partnering with best-in-class technology providers but is also supported by a suite of differentiated ICON proprietary technologies. Through an informatics strategy built around key platforms, including ICONIK and Health Cloud, the company has continued to invest in building its capabilities in the gathering, analysis and application of real world patient data within both the clinical trial and post-trial observational study environments. ICONIK and Health Cloud enable ICON to deliver services, such as Risk Based Monitoring (RBM), which uses near-real time clinical data to drive monitoring visit schedules, enabling better decision making and the successful implementation of clinical trial strategies that significantly improve efficiency in clinical trials thereby reducing time to market whilst better protecting patient safety. ICON's proprietary One Search tool helps to efficiently and effectively identify optimum trial sites. It synthesizes multiple data sources, applying AI machine learning and rich data visualization for optimum site identification, resulting in improved study start-up and site cycle times, significant reductions in the percentage of low performing sites and increasing the percentage of studies meeting planned First Patient In (FPI). FIRECREST is ICON's proprietary comprehensive site performance management system. It is a web-based solution which enables accurate study information, including protocol information, training manuals and case report forms, to be rolled out quickly and simultaneously to investigative sites. It allows site behavior to be tracked to ensure training is understood, procedures are being followed and that timelines and study parameters are met. It can significantly reduce the number of data queries originated from investigator sites. FIRECREST is now integrated into the ICON Safety Reporting Solution and provides a Site Question Management Tool. The ICON Patient Engagement Platform was developed to support improved patient experience and enrollment in clinical trials. The web-based patient engagement platform, provides patients with study specific information and connectivity with the nearest investigative site. The solution supplements patient recruitment outreach by sites and increases visibility of potential study participants for sponsors and sites. An easy to navigate, user friendly interface guides the patient to new and ongoing studies in their particular indication and a pre-qualification questionnaire helps to determine if the study is a right fit for them. If the patient decides to register interest, they are given the option to select their nearest investigative site. This establishes connection with the site and the patient can then choose to contact the site or ask to be contacted for pre-screening. The company positively impacts patients' lives by understanding their journeys and how they can benefit from drugs in development and on the market. The company does this by developing a holistic, global data environment across pharmaceutical and biotech companies (development to commercial) that gives insights into patients, and how best to serve them. Alongside the application of these technology solutions the company is also focused on innovation through the redesign and where appropriate the automation of current clinical trial processes. Capabilities and Service Offerings ICON is the world's largest pure-play clinical research organization. From molecule to medicine, the company advances clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. The company develops new innovations, drive emerging therapies forward and improve patient lives. The company's focus is on delivering Healthcare Intelligence to customers to address the full spectrum of clinical development challenges, not just point-of-service delivery. The synthesis of the company's 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, the company delivers 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: Partnerships The company's existing partnerships continue with the following organizations: The ICON-McKeon Research Fellowship in Motor Neuron Disease ('MND') in honor of Mr. Declan McKeon, former Board member, acting Chairman, Lead Independent Director and Chair of the ICON Audit committee. The ICON-McKeon Research Fellow in MND carries out research in the areas of machine-learning and artificial intelligence to derive insights from multimodal clinical, imaging neuro-electric signaling, in the context of the neurodegenerative disease of ALS. Partnership with Trinity Centre for People with Intellectual Disabilities ('TCPID') - TCPID situated within the School of Education, Trinity College Dublin, aims to promote the inclusion of people with intellectual disabilities in education and society. The Centre provides people who have intellectual disabilities with the opportunity to participate in a higher education program designed to enhance their capacity to fully participate in society as independent adults. The 2-year education program includes work placements and internships to enable students to experience and participate in the work environment. In 2023, the company was delighted to host a student visit from TCPID students to the company's global headquarters in Dublin, where they enjoyed learning about the different phases of a clinical trial and also experienced a working laboratory during a tour of the facility. 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. Aligned with the company's ambitions to build closer ties between industry and academia, create a more diverse graduate pool of talented and ambitious STEM professionals who can help to ensure the future success of the life sciences industry, and provide increased opportunities for underrepresented groups to study STEM courses, the company's STEM scholarship program continued in 2023. Through the program, ICON is partnering with three universities in Ireland - Dublin City University (DCU), Trinity College Dublin (TCD) and the University of Limerick (UL) - as well as with the Thurgood Marshall College Fund (TMCF) in the U.S., to fund 33 scholarships for students of STEM courses. TMCF is a not-for-profit organization that supports nearly 300,000 students attending its 47 member-schools that include publicly-supported Historically Black Colleges and Universities (HBCUs). Sales and Marketing The company's marketing activities are coordinated centrally to ensure a consistent and differentiated market positioning for ICON and to ensure all marketing efforts align to the overall strategic objectives of the business. The company's business development teams are located throughout the Americas, Europe and the Asia Pacific regions. Business development activities are carried out by account executives with assigned territories and global account directors supporting the company's large accounts. Specialized business development teams focus on growing each of the company's business areas. Collectively, the company's business development team, senior executives and project team leaders share responsibility for the maintenance of key client relationships. The company's intention is to develop deeper relationships within the company's client base to gain repeat business and enable the company new opportunities to penetrate into other therapeutic indications and adjacent service lines. Competition 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. Customers The company's largest customer represented a strategic partnership with a large global pharmaceutical company and contributed 8.9% of revenue for 2023. Government Regulation In providing services in the United States, the company is obligated to comply with FDA requirements governing such activities. The services the company provides outside the United States are ultimately subject to similar regulation by the relevant regulatory authority. In addition, the company's activities in Europe are affected by the European Medicines Agency. History ICON Public Limited Company was founded in 1990. The company was incorporated in Ireland in 1990.
