PURPOSE
This is a personal invite to the webinar which will focus on how
mid-market quality assurance, risk and clinical operations leaders
and teams understand why AI governance and traceability is now
essential in trial delivery. To give them a practical,
sponsor-controlled way to deliver earlier visibility of deviation
risk without replacing existing systems.
By the end, attendees should be able
to:
1. Explain what “inspectable oversight” means
(human-in-control, traceable evidence) within the context of AI
governance.
2. Identify where deviation risk hides across
EDC/CTMS/eTMF/vendor reporting and why it’s missed.
3. Leave with a clear next step: a simple approach to
implement governance-grade oversight in their own trials.
AGENDA
26th March 1600 - 1700 GMT
1) AI Governance in Trial Oversight: Defensible, Human-Controlled
Decisions
Ed Dixon (CEO)
Ed will set the frame for governance-first adoption of AI in
clinical trials oversight. He’ll explain what “AI governance” means
in practical QA/ClinOps terms in human-in-control decision rights,
traceability, transparency, and auditability—and why “inspectable
oversight” is now the standard. The focus is how to use AI to
surface risk earlier while producing evidence a sponsor can defend
during audit or inspection.
2) The Mid-Market Trial Operations Reality: Why Oversight
Breaks
Paul Agapow PhD (Chief Scientific Officer, ex GSK,
Biontech)
Paul will unpack the operational conditions
that make mid-market sponsors uniquely exposed: lean teams, rising
trial complexity, heavy CRO reliance, and fragmented signals spread
across CTMS, EDC, eTMF, vendor reports and trackers. He’ll show why
risk is often seen too late, why dashboards don’t fix the
underlying cadence and ownership issues, and what an effective
oversight rhythm needs to look like in practice.
3) Deviation Oversight That Stands Up to Audit:
Turning Signals into Action
Francis Osei (Head of Clinical
Trials)
Francis will focus on deviations as the
highest-impact starting point and the area where governance matters
most. He’ll cover where deviation risk hides, how under-escalated
issues emerge across systems and vendor artefacts, and what QA
needs to defend decisions using a clear evidence chain from source
→ signal → human decision → action/CAPA → outcome.
4) Questions & Answers.
Attendees will leave with a practical view of what
improves when oversight becomes inspectable: earlier detection,
less rework, and stronger inspection readiness.
