eTMF

Medidata eTMF is an electronic trial master file solution designed to help clinical trial teams maintain inspection readiness throughout the study lifecycle. Rather than relying on manual document management and periodic reconciliation, the platform automatically updates as study work is completed, ensuring the TMF consistently reflects the current state of the trial. It is built for sponsors, CROs, and lean clinical operations teams managing both simple and complex studies at scale.

By reducing administrative burden and providing continuous visibility into document status, Medidata eTMF allows teams to focus on study oversight rather than filing coordination. The solution is part of the broader Medidata Platform, enabling deep integration with Rave EDC and Medidata CTMS for a unified clinical operations environment.

Core Capabilities

• Automatic TMF updates: As work is completed in Rave EDC and Medidata CTMS, documents and metadata are populated automatically, minimizing manual filing and reconciliation efforts.
• Auto-filing and intelligent placeholders: Standardized structures and intelligent placeholders ensure required documentation is created and organized without added coordination across teams.
• Real-time oversight: Dashboards provide live visibility into TMF status, so teams always have a clear picture of document completeness and study progress.
• Live TMF migration support: The platform supports migration of existing trial master files, enabling teams to transition without disrupting ongoing study operations.
• Support for simple and complex studies: The solution scales to accommodate a wide range of study types and sizes.

Integration with the Medidata Platform

• Medidata eTMF is unified with Rave EDC and Medidata CTMS on the Medidata Platform, enabling instant auto-population of content and data from these applications.
• Data from Rave EDC populates directly into dashboards, providing up-to-date study information without manual uploads.
• Monitoring visit reports generated in Medidata CTMS are automatically filed into the TMF, keeping the system complete and contemporaneous at all times.

Document Management and Search

• Advanced search algorithms allow users to locate artifacts based on content, title, and metadata, making retrieval fast and reliable.
• Auto-naming capabilities standardize content across the TMF, simplifying search and management of both regulated and non-regulated documents within a single interface.
• Full support for the Drug Information Association (DIA) TMF Reference Model is included, along with an out-of-the-box DIA file plan configuration to ensure compliance with industry standards.
• Study plans can be generated quickly using the pre-configured DIA file plan, reducing setup time at study start.

Inspection Readiness and Compliance

• Inspection readiness is built into the default state of the system, rather than being an ongoing manual task requiring periodic review cycles.
• Automated quality checks and standardized filing structures reduce the risk of gaps or inconsistencies in the TMF.
• Seamless collaboration features support cross-functional teams working across sites and geographies.

Implementation and Training

• Medidata eTMF is designed for rapid deployment using agile planning and implementation methodologies, with a typical go-live timeline of as little as six weeks from kick-off.
• Medidata offers a variety of training options for clients and partners, including both self-paced and instructor-led courses through the Medidata Global Education and Training program.

In a documented case study, Enterin used Medidata eTMF to automate TMF workflows, streamline monitoring, and reduce manual effort, saving five to six hours per week while also lowering site burden — demonstrating the platform's practical value for lean clinical operations teams.