Talk Main Conference TMF track
Case Study: The 12-Month TMF Turnaround : Oversight, Alignment, and Inspection Readiness
Tue, Oct 6, 2026 · 10:00–10:30 AM MDT Evergreen D, Denver Marriott Tech Center
About this session
Part of Session 5, Track D: Inspection Readiness (Chair: Steph Viscomi, Kymera Therapeutics).
Strong sponsor oversight is essential to achieving an inspection-ready Trial Master File (TMF), yet many organizations struggle to move from intention to execution. This case study highlights how a sponsor's TMF evolved from limited oversight to inspection readiness within 12 months, supported by a successful audit and mock inspection.
The session will share a high-level view of the approach used, key challenges encountered, and practical lessons learned along the way. Attendees will gain insight into how focused oversight, collaboration, and process improvements can strengthen TMF quality and support sustainable inspection readiness.
Speaker
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Owner & TMF Consultant · ICE Consulting
Speaker
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