Complexity to Catalyst: Building Site Readiness, Resilience & Innovation

Clinical trial complexity is rising with more procedures, endpoints, and technology, yet sites are turning these pressures into pathways for improvement. In this episode of WCG Talks Trials, host Jenna Goeller sits down with Trevor Cole to unpack practical ways research sites sustain readiness, build resilience, and spark innovation amid frequent protocol amendments and technology overload. Together, they explore what’s changing on the ground and how sites are responding with stronger feasibility reviews, capacity planning, streamlined protocol advocacy, and risk‑proportionate oversight – all grounded in Quality by Design and the updated ICH E6(R3) guidance.

Listeners will hear data‑driven insights on:

• The operational ripple effects of complexity, including resource strain, rework from amendments, and tech support burdens, and what’s working to reduce them.
• Day‑to‑day applications of risk‑based quality management, data governance, and proportionality to protect participant safety and data integrity.
• Culture and maturity for empowering teams, mapping processes before SOPs, continuous training, Correction and Preventive Action (CAPA) discipline, and knowledge sharing across silos.
• How sponsors and CROs can better support sites through integrated technology, protocol simplification, early collaboration, and transparent communications.
• Turning complexity into growth by investing in people and processes, using fit‑for‑purpose tech (including selective AI use), and engaging local communities.