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Governing AI in Clinical Trials Oversight Webinar

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About this event

What to expect

Clinical trial sponsors and quality assurance teams face a critical challenge: as AI becomes embedded in trial oversight workflows, regulatory expectations around governance, traceability, and human control are rapidly evolving. This webinar addresses how quality assurance, risk management, and clinical operations leaders can implement inspectable oversight that stands up to audit while leveraging AI to surface critical signals earlier.

What You'll Learn

This session explores why AI governance and traceability are now essential in trial delivery, particularly for mid-market sponsors managing complex trials with lean teams and heavy CRO reliance. The webinar covers three core areas:

AI Governance Fundamentals: Understand what "AI governance" means in practical QA and clinical operations terms — human-in-control decision rights, traceability, transparency, and auditability. Learn how to use AI to surface risk earlier while producing evidence a sponsor can defend during audit or inspection.

Operational Reality Check: Discover why oversight breaks in mid-market trial operations. Paul Agapow PhD (Chief Scientific Officer, formerly GSK) unpacks the conditions that make sponsors uniquely exposed: lean teams, rising trial complexity, CRO reliance, and fragmented signals spread across CTMS, EDC, eTMF, vendor reports and trackers. Understand why risk is often seen too late and why dashboards don't fix underlying cadence and ownership issues.

Deviation Oversight That Stands Up to Audit: Francis Osei (AI Clinical Trials Lead) focuses on deviations as the highest-impact starting point. Learn where deviation risk hides across EDC/CTMS/eTMF and vendor data, how under-escalated issues emerge, and what QA needs to defend decisions using a clear evidence chain from source → signal → human decision → action/CAPA → outcome.

Who Should Attend

This webinar is designed for quality assurance leaders, risk management professionals, clinical operations teams, and anyone responsible for regulatory compliance and protocol oversight in clinical trials. Whether you're managing trials directly or overseeing CRO performance, you'll gain practical frameworks for implementing governance-grade oversight.

Organized by Bayezian

This is the first in a series of webinars from Bayezian, focused on practical approaches to AI governance in clinical trial delivery. The session runs for one hour and delivers actionable n

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