Medidata eTMF: Simplify Trial Oversight With Unified Document Management

A robust and reliable electronic Trial Master File (eTMF) must be continuously inspection-ready, supported by clear, accessible metrics that enable proactive monitoring and effective collaboration across sponsor, CRO, and site teams. In today’s complex clinical trial environment, the eTMF must do more than store documents — it must reflect the current state of the study at all times and support confident regulatory oversight.

Medidata eTMF is a global, secure collaboration platform designed to ensure trial master file content remains complete, accurate, and contemporaneous with study execution. By seamlessly managing TMF documents throughout the study lifecycle, Medidata eTMF helps organizations maintain ongoing inspection readiness while reducing operational burden.

The platform supports a risk-based quality control (QC) review approach, enabling teams to focus resources on the most critical content. Content creation and management are streamlined through automated population of documents and metadata generated in connected Medidata applications, significantly reducing manual filing and reconciliation efforts and establishing a true single source of truth across systems.

As a result, document creation timelines are shortened, and the time required to reconcile site files with the trial master file is substantially reduced. Medidata eTMF also supports live study migrations and long-term eTMF archiving, ensuring continuity, compliance, and data integrity across the full trial and post-trial lifecycle.