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Session 2 Track 3 - Establishing Processes and Controls to Ensure an Inspection-Ready TMF Every Day
Session Chair(s)
Lisa Mulcahy
Owner, Principal Consultant
Mulcahy Consulting, LLC, United States
Problems with TMF quality can now be a critical finding during a regulatory inspection; further motivating life sciences organizations to ensure their TMFs are inspection ready at all times. This session provides real-life case studies from two companies who have adopted an electronic, integrated TMF approach to enable inspection readiness. Speakers will explain why direct access to the eTMF is critical for all stakeholders, and describe how they use remote access to provide internal and external parties with the appropriate level of access to submit, collect, QC, and approve trial documents.
Speaker(s)
Benefits and Challenges of Establishing an eTMF in a Clinical Trial
Rebecca Moraris
Firma Clinical Research, United States
Director, Clinical Management
Using a Cloud-based eTMF to Improve Quality and Document Management Processes
Jen Goldsmith
Veeva Systems, United States
Incorporating Quality Reviews of the TMF into Everyday Work Processes: Basic Strategies to Implement Today!
Lisa Mulcahy
Mulcahy Consulting, LLC, United States
Owner, Principal Consultant
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