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