- Implementing ICH E6(R3) expectations
- Defining effective oversight and KPIs
- Strengthening sponsor – lab partnerships
- Managing compliance and quality risks
- Lessons learned and future priorities
Archives: Agenda
Morning refreshments and networking break
Prize Draw in Exhibition Hall
END OF DAY ONE & DRINKS RECEPTION
Lunch and networking
END OF DAY ONE & DRINKS RECEPTION
Lunch and networking
END OF DAY ONE & DRINKS RECEPTION
Evolving sponsor operating models to accommodate the shift to risk-based, centralized, and AI-enabled study monitoring
The clinical trial monitoring function has been transforming as sponsor companies move beyond traditional monitoring to accommodate risk-based, centralized, and AI-enabled approaches. This session explores specific organizational changes that have been made to support this transformation and its impact workforce capacity, timelines and efficiency. Attendees will gain practical insights into building monitoring models that enhance study quality, operational efficiency, and regulatory readiness.