Electronic Trial Master File (eTMF)
We utilize Vault eTMF (Veeva Systems, Inc.) to provide unique and scalable solutions to maintain eTMFs with inspection-readiness practices incorporated into daily operations.
Overview of expertise:
- Assist companies in developing a strategy for the implementation of an eTMF
- Provide and implement an instance of Veeva Vault Clinical eTMF rapidly
- Provide experienced staff to help guide the process and act as document managers
- Develop a TMF Plan and associated metrics
- Perform QC on eTMF on a basis as determined by the Sponsor (typically quarterly)
- Ensure Sponsor access to their documents in real-time with efficient receipt to upload times
- Manage eTMF life cycle by effectively planning, collecting, and maintaining clinical trial documents on an ongoing basis
- Monitor and understand the health of the TMF in real time
