Expanding clinical trials into new countries is no longer a simple “country list” exercise. Sponsors face rising protocol complexity, persistent under enrolment, and growing site burden risk challenges that are amplified when entering unfamiliar health systems, regulatory environments, and site ecosystems. Too often, patients are present, but experienced investigators, site capability, and delivery infrastructure are not.

In this webinar, IQVIA explores a patient population first approach to country and site decisions connecting early feasibility to the realities of site capability, readiness, and execution risk. Drawing on proven global expansion learnings and structured readiness thinking, we outline how sponsors can pair Strategic Site Solutions insight with a hands-on site engagement layer that builds protocol-level understanding of how sites actually operate.

Central to this approach is the role of Site Enrollment and Engagement Lead who act as an on-the-ground bridge between strategy and execution. Through structured site assessment, Site Enrollment and Engagement Lead identify gaps in capability, capacity, and processes, and enable targeted, flexible interventions such as training, resourcing, and patient engagement to elevate site performance where it matters most.

The result is a more connected approach to country expansion one that moves beyond patient access to activate site performance enabling smarter country selection, stronger start-up, and more predictable enrolment in new geographies.

Key Takeaways

• A practical framework to pressure-test country choices beyond patient counts — including investigator experience, site maturity, and real-world delivery conditions.
• Sponsors are increasingly entering regions where patients exist—but site readiness is variable. The challenge is not access—it is consistent, reliable delivery at the site level.
• Why patient availability ≠ recruitment success — and how to validate country and site readiness early in the decision-making process.
• How an engagement bridge between strategy and enablement—through Site Enrollment and Engagement Lead site assessment—reveals real constraints before decisions are locked in.
• The role of Site Enrollment and Engagement Lead in identifying site-level barriers and deploying targeted, flexible interventions (e.g. training, staffing, engagement strategies) to unlock performance.
• Where targeted enablement reduces burden, strengthens site capability, and protects timelines during start-up and early enrolment.

Speakers:

Kelly Sanford
Head of Operations, Site Enablement Solutions
IQVIA (US)

Sarah Thinnesen
Director of Site Enrolment and Engagement Leads
IQVIA (UK)

Jose Luis Carbajales
Director of Site Enablement Solutions
IQVIA (Spain)