ICON survey reveals increasing clinical trial startup delays, underscoring need for human-centred site activation solutions

Dublin, Ireland – 2 December 2025 – ICON plc (NASDAQ: ICLR), a world-leading clinical
research organisation, today announced results of its latest industry survey, examining the challenges clinical trial sites face during study startup. The findings underscore the need for a site-centric, collaborative approach to overcome bottlenecks and enhance trial activation timelines.

The survey, conducted in June 2025 among just over 100 principal investigators and senior clinical trial site personnel, gathered perspectives from a wide range of clinical trial sites and is not limited to studies managed by ICON. It reveals widespread sentiment that sites are increasingly burdened by operational bottlenecks, contract and budget delays, and communication gaps. These challenges contribute to significant disruptions at the startup stage, with 55% of respondents reporting that time from site selection to full activation is longer than 5 months, and 39% reporting longer timelines than two years ago.

Contract and budget delays are a persistent issue, with 66% of respondents experiencing
them frequently. Almost all respondents (92%) identified these as the top areas where both sponsors and contract research organisations (CROs) can improve support. With 47% of respondents rating sponsor and CRO communication as average or poor, this highlights a critical need for site-centricity.

“AI and operational advancements are opening new possibilities for smarter, faster trials, yet many sites still face persistent challenges that delay activation and disrupt momentum,” said Brian Mallon, ICON Executive Vice President, Site and Patient Solutions. “These delays are solvable. Sponsors have a clear opportunity to improve communication and adopt approaches that centre on the human experiences of site personnel. By simplifying documentation, smoothing negotiations, and fostering open collaboration, we can build a thriving ecosystem for trial start-ups - one that prioritises site needs and accelerates access to new therapies.”

ICON has consolidated these industry survey findings in a new whitepaper, entitled, ‘From
bottlenecks to breakthroughs: Human-centred solutions for faster study starts’. It includes new ICON data analysing pharmaceutical and biotech studies between 2021-2023 which revealed site pre-selection decline rates rising from 35% to 47%, further highlighting the importance of addressing the factors that lead them to drop out.

The whitepaper outlines actionable strategies for streamlining start-up and empowering
clinical sites including:

Implementing site engagement approaches that balance alignment and competing
priorities
Utilising human-enabled predictive analytics to identify optimal sites and streamline
budget and contract negotiations
Adopting data-informed over-selection strategies to mitigate site attrition
Deploying coordinated site networks and structured governance agreement

For further information please visit www.ICONplc.com/startup.

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About ICON plc

ICON plc is a world-leading 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 39,900 employees in 95 locations in 55
countries as of June 30, 2025. For further information about ICON, visit: www.iconplc.com.

Media contacts:

Lisa Henry (GMT time zone)
Weber Shandwick (PR adviser)
+447785 458203
lhenry@webershandwick.com

ICON Press Office
iconnews@webershandwick.com

ICON survey reveals increasing clinical trial startup delays, underscoring need for human-centred site activation solutions