ICON releases expanded end-to-end Clinical Trial Tokenisation solution

Dublin, Ireland – 20 September 2023 – ICON plc, (NASDAQ: ICLR) a world-leading healthcare intelligence and clinical research organisation, today announces the release of its next generation Clinical Trial Tokenisation solution. The combination of ICON’s proprietary tokenisation engine, access to real-world data and advanced clinical analytics expertise, now delivered through a cohesive and seamless operational model, provides valuable, long-term insights on drug safety and efficacy, throughout the product development lifecycle.

ICON’s next generation proprietary Clinical Trial Tokenisation solution seamlessly integrates all the necessary components to allow for the collation of patient data in a consented, discreet and non-intrusive way with Privacy Protected Record Linkage (PPRL) across time and source. Furthermore, ICON’s capability to generate multiple tokens, coupled with advanced analytics, provides highly accurate matching (up to ~90%) of clinical trial participants to the largest ecosystem of real-world data sources in the United States. This enables the best available secondary data to be used, resulting in enhanced evidence generation in a highly cost and time efficient manner for our customers, with robust protection of patient privacy.

Valuable insights from this offering can be leveraged in many ways, including regulatory and reimbursement discussions and scientific publications to optimise clinical development lifecycles.  This can also be used to better understand the response of specific sub-cohorts of patients, and to conduct long-term safety surveillance.

ICON’s Clinical Trial Tokenisation solution is delivered within an operating framework aligned to industry security and data privacy standards, and its corporate security and data protection programs have been assessed to ISO 27001 and 27701 standards.

Steve Cutler, CEO, ICON commented: “As an early pioneer of clinical trial tokenisation, ICON fully understands the potential it has to transform clinical development. This enhanced integrated offering enables customers to leverage powerful analytics in an efficient and cost-effective manner for greater understanding and insights of trends in disease, indication and treatment patterns that will support better decision making at every stage of the product lifecycle.”

ICON is uniquely positioned to support customers because, in addition to commercialisation capability, it has extensive experience in clinical research, regulatory management, and healthcare intelligence, all crucial to clinical trial tokenisation.

Further information on this enhanced offering can be found at ICONplc.com/tokenisation and ICONplc.com/digital-platform.

Ends

This press release contains forward-looking statements, including statements about our financial guidance. These statements are based on management's current expectations and information currently available, including current economic and industry conditions.  These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release.  The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, the impact of COVID-19 on our business, as well as other economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word "expected" and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, F-4, S-8, F-3 and certain other reports, which are available on the SEC's website at http://www.sec.gov.

About ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,160 employees in 108 locations in 53 countries as at June 30, 2023. For further information about ICON, visit www.iconplc.com.

Media contacts:

Claire Quinn (GMT time zone)

Corporate Communications, ICON plc

claire.quinn@iconplc.com

+353 87 4066091

Weber Shandwick (PR adviser)

Lisa Henry (GMT time zone)

+447785 458203

lhenry@webershandwick.com

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