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Session 4 Track 3: eTMF Collaboration in Outsourced Studies
Session Chair(s)
Joanne Malia, MS, MSc
Director, Development Records Management
Regeneron Pharmaceuticals, United States
Utilizing experiences and case studies from both the Sponsor and CRO side, we will outline typical operating models, and introduce potential new models for consideration, outlining the pros and cons of each, importantly, for both the Sponsor and CRO.
In deciding on an operating model, it is important to understand the total cost of ownership holistically, as well as the impact to Inspection Readiness, and the roles and responsibilities between CRO and Sponsor.
Managing Trial Master File and Regulatory documents in an outsourced model can be a stressful and challenging effort, if the operating model is not well thought out and planned for. In this session you will hear from both Sponsor and CRO experiences.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the operating model options for eTMF management and Regulatory documentation with a CRO
- Understand the impacts both from Sponsor and CRO of each option
- How advanced technologies and frameworks such as RPA and the TMF Reference Model Exchange Mechanism can facilitate
Speaker(s)
eTMF Collaboration – What are the Operating Models?
Jamie O'Keefe
Astrix, United States
Head, Clinical & Regulatory Consulting
TMF Collaboration: Sponsor View
Mallorie Sayre, MLIS
Moderna, United States
Associate Director
TMF Collaboration: CRO View
JP Miceli
Advanced Clinical, United States
Associate Director, Document Management
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