A large pharmaceutical sponsor launched a global clinical trial in a new indication they had not previously worked in, targeting elderly patients with a history of urinary tract infections (UTIs) over the past two years. The sponsor opted to identify sites internally, launching 125 sites across 15 countries in Asia-Pacific, North America, and Europe.

However, site performance quickly lagged. With an expected enrolment rate of 4 patients per site per month (p/s/m), actual enrolment came in at just 1 p/s/m, a significant shortfall. More critically, 70% of the existing sites were non-enrolling, jeopardising study timelines and data integrity.

ICON was brought in to rescue the study. The Feasibility and Site Activation (FSA) team conducted a rapid assessment to understand performance gaps and establish realistic enrolment benchmarks:

• 4 p/s/m was deemed unreasonable
• 2 p/s/m was considered achievable
• 1 p/s/m remained a marker of significant underperformance

To turn the study around, ICON used One Search, its proprietary AI-enabled site identification platform, to identify and prioritise high-potential sites within the existing study footprint. Within 10 weeks, ICON:

• Applied One Search analytics to select new sites
• Identified 125 additional sites
• Completed site identification across the same countries

The newly activated 125 sites delivered dramatically improved performance:

• 2.5 p/s/m enrolment rate, sustained for over a year
• Only 10% of new sites were non-enrolling—a stark contrast to the initial 70%
• The sponsor was so impressed that they expanded ICON’s role, requesting another 125 sites across 12 new countries to further accelerate enrolment

This case underscores the measurable impact of strategic, data-driven site selection in clinical trial success. By harnessing the power of One Search, ICON was able to rapidly identify high-performing sites, reverse enrolment shortfalls, and restore momentum in a study that was at serious risk. One Search provided the insight and speed needed to course-correct and deliver results.

Whether you're navigating a rescue study or planning your next trial from the ground up, ICON’s approach to intelligent site identification can help you optimise enrolment, reduce non-performing sites, and accelerate timelines with confidence.