Free Live Webinar · Session 2 of 6
Validating AI and ML in Clinical Systems: Extending CSA to GCP
Most clinical teams already own the discipline they need to validate AI. They just haven't pointed it at clinical systems yet.
What you'll take away
- How to apply risk based CSA principles to AI and ML inside clinical systems
- What context of use and credibility evidence mean in practice, not in theory
- Where sponsor and vendor validation responsibilities split, and how to document it
- The questions to ask before an AI-enabled clinical system goes live
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Validating AI and ML in Clinical Systems: Extending CSA to GCP
Why now
The system learns. The validation has to keep up.
AI and ML are moving into EDC, CTMS, eTMF, and monitoring platforms, and the question landing on clinical teams is how you validate a system that learns, and how you prove it to an inspector.
This session extends CSA into the GCP world: what changes when a system is probabilistic rather than deterministic, how to define context of use and credibility evidence, and what an inspection-ready validation package looks like when the vendor owns the model and you own the trial.
Sponsored by
At Genari AI, our mission is clear: to harness the power of artificial intelligence and specialized Life Science services to create intelligent, adaptive, and innovative solutions that drive progress, unlock new possibilities, and enrich lives. We are committed to bridging the gap between cutting-edge technology and practical applications in healthcare, placing the needs and aspirations of individuals at the center of everything we do.
Built for
Who should attend.
Built for the people who have to validate, govern, and defend AI-enabled clinical systems.
Clinical Quality Assurance
GCP Compliance
GCP Auditors
Regulatory Affairs
Clinical Operations
Clinical Data Management
CSV / CSA
IT Quality
Clinical Systems
The panel
Who you'll hear from.
A panel of practitioners who live inside these questions, moderated live with audience Q&A.
Moderator
Tim Roy Kirkelie
Co-Founder & COO
Genari AI
Panelist
Munya Mafemba
Director, Digital Quality Assurance
Signant Health
Panelist
Amanda Forsythe
Head of Quality
Carelane
Panelist
Ankita Mishra
Digital Health Quality Director
Evinova
The series
Part of AI in Clinical Operations & Clinical Trials.
Six live panels on where artificial intelligence is reshaping clinical trials. Free to attend, and every session recorded.
3
Oct 27, 2026
6
Generative AI for Protocols, CSRs, and Regulatory Narratives
Jan 14, 2027
