Transforming TMF Oversight: Applying AI to Address Persistent Site Personnel Record Gaps

About this session

Part of Session 3, Track D: AI in TMF Management (Chair: Steph Viscomi, Kymera Therapeutics).

Periodic review of clinical trial documentation is essential to ensure that TMF records present a clear, consistent, and inspection ready narrative. However, manual oversight approaches are often tedious, resource intensive, and cost prohibitive. To address these challenges, CSL Behring, in collaboration with Just In Time GCP, conducted a pilot to evaluate an AI driven TMF review and service model with a focus on site personnel records. Site personnel documentation post site greenlight remains a persistent TMF management challenge and a focal point for regulatory inspection. Discrepancies at the site personnel level also frequently indicate broader risks within the TMF.
This presentation will describe the pilot's operational model, highlighting key lessons learned and practical considerations for integrating AI into TMF workflows to strengthen oversight and enable sustained inspection readiness. These insights contribute to the broader discussion on the evolving role of AI in TMF management.

Speakers

• NS

  Niamh Smith

  CSL Behring

  Speaker

• AG

  Aaron Grant

  Just in Time GCP

  Speaker