Manage TMF Oversight With Vault eTMF

Sponsors that outsource clinical trial management activities to contract research organizations (CROs) retain the regulatory responsibility for the quality and integrity of trial data and conduct. Adherence requires sponsors to have systems and processes in place to ensure adequate sponsor oversight, as well as document and demonstrate how the trial master file (TMF) is set up and maintained.

Yet sponsors may lose oversight of the TMF in outsourced studies because the TMF structure lacks consistency across multiple systems and partners, increasing the risk of inspection findings, delayed trials, and unexpected costs.

Veeva Vault eTMF gives sponsors real-time and secure access to clinical documentation at every point throughout a trial’s setup, execution, and archival. It provides the visibility, transparency, and control to oversee trials more effectively, while removing the need for costly end-of-study migrations.