Product/Service

Electronic Trial Master File (eTMF)

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We utilize Vault eTMF (Veeva Systems, Inc.) to provide unique and scalable solutions to maintain our clients’ eTMF with inspection-readiness practices incorporated into daily operations.

Study eTMF Manager:

  • Assist in developing a strategy for the implementation of an eTMF
  • Provision and implement Veeva Vault eTMF:
    • Provide experienced staff to guide the implementation process
    • Act as document managers
  • Develop a TMF Plan with associated metrics
  • Perform periodic QC on eTMF
  • Allow for real-time access to filed documents by ensuring efficient receipt-to-upload times
  • Manage eTMF lifecycle by effectively planning, collecting, and maintaining clinical trial documents on an ongoing basis
  • Monitor and understand the health of the TMF in real time

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