Breakout Session I
AI Applications For Site Success
Sites are no longer asking whether AI belongs in clinical research — they are asking how to make it work and who should be building it. Move past the theoretical to analyse tools site teams are using today for document management, query response, scheduling, and patient communications. We’ll address the gap between AI designed for sponsors and AI that genuinely serves sites, exploring what it would look like for industry and sites to co-develop solutions rather than have them imposed. Leave with a framework for evaluating AI tools and a clear view of what’s worth implementing now.
Developing The Next Generation Of Site Teams
Behind every successful trial is a stable, skilled, motivated team, and building that team is one of the hardest things site leaders do. This conversation will focus on the full spectrum of workforce development: hiring for clinical research roles including non-clinical positions, retaining people in a competitive environment, developing site leaders from within, and building a culture that sustains performance across the pressures of a busy site. Coordinator-specific content, manager development, and how to make research a compelling career pathway will be featured.
Europe’s Competitive Edge: The Regulation & Reform Impact
Europe’s clinical trial landscape is at an inflection point. EU CTR implementation, IVDR requirements, evolving EMA guidance, expedited regulatory pathways in the EU and UK, and competitive pressure from global regions are reshaping how sites, sponsors, and regulators interact. Regulatory experts and site leaders will examine what is working, what remains fragmented, and what it will take to ensure Europe remains a destination of choice for clinical trials. Spain’s fast-track model, non-EU country comparisons, and the EU Biotech Act implications for sites will all be discussed, with a focus on moving from diagnosis to action.
Protocol Complexity & Its True Cost
Protocol complexity has been growing steadily, and sites are absorbing the cost in staff time, patient burden, and enrolment delays. What does increasing complexity actually mean for site workload, why does it happen, and what can sites and sponsors do about it? This direct conversation will share how simpler protocols improve both site performance and patient experience, discussing the site’s role in pushing back on protocol design before activation rather than absorbing the consequences after. Attendees will practise framing protocol feedback in ways that sponsors actually hear.
Retention Through Connection: Keeping Patients Engaged
High patient dropout rates undermine data quality, statistical power, and regulatory acceptability while extending timelines and increasing costs for sites and sponsors alike. Patient retention is often treated as an afterthought in protocol design, yet it is one of the most controllable levers sites have. Review what drives dropout across different trial types and patient populations, engagement strategies making a measurable difference, and how sites and sponsors can better support participants throughout the study. We will also discuss how post-trial access can be used as a retention tool — and what that looks like in practice.
The Race From Approval To Enrolment
The industry focuses heavily on start-up speed, but experienced sites know that the distance from clinical trial approval to last patient in (and last patient last visit) is where the real performance story is told. Understand the end-to-end timeline with fresh eyes, looking at what successful programs have learned about accelerating delivery across the continuum. Attendees will examine where their own sites are losing time and leave with a clearer view of the interventions that make the biggest difference.