Medidata eTMF
Keeping a trial master file (TMF) inspection-ready requires more than storing documents. Teams need confidence that what’s in the TMF reflects what’s actually happening in the study, without constant manual checks and reconciliation.
Medidata eTMF automatically updates as study work is completed, reducing the effort to review and manage filing as studies scale.
Simplify Oversight at Scale
Medidata eTMF makes inspection readiness the default, not an ongoing task. By reducing manual steps and keeping document status clear across the study lifecycle, teams spend less time managing the TMF and more time overseeing the study.
Clear Visibility into TMS Status
Automatic TMF Updates as Studies Run
Live TMF Migration Support
Real-time Oversight
Support for Simple and Complex Studies
What You’ll Gain with Medidata eTMF
Reduced Complexity
Save Time with Automated Workflows
As work is completed in Rave EDC and Medidata CTMS, documents and metadata are populated automatically, minimizing manual filing and reconciliation.
Auto-filing, standardized structures, and intelligent placeholders ensure required documentation is created and organized without added coordination, so teams focus on oversight, not administration.
Featured Resource
Automated TMF Workflows for Lean Teams
Managing confirmation letters, reports, and oversight updates can quickly overwhelm small teams. Explore how Enterin used Medidata eTMF to automate TMF workflows, streamline monitoring, and reduce manual effort—saving 5-6 hours per week while lowering site burden.
Read Case Study
FAQ
How does Medidata eTMF integrate with Rave EDC and Medidata CTMS?
Medidata eTMF is unified with Rave EDC and Medidata CTMS on the Medidata Platform, allowing it to instantly auto-populate content and data from these applications. For example, data from Rave EDC populates directly into dashboards, and monitoring visit reports generated in CTMS are automatically filed into the TMF, ensuring the system remains complete and contemporaneous without manual uploads.
Does the platform support the DIA TMF Reference Model?
Yes. Medidata eTMF provides full support for the Drug Information Association's (DIA) TMF Reference Model and includes an out-of-the-box DIA file plan configuration. This ensures that study plans can be generated quickly while maintaining industry standards for compliance.
What is the typical implementation timeline for Medidata eTMF?
The solution is designed for rapid deployment using agile planning and implementation methodologies. Typically, the installation process—from kick-off to go-live—takes as little as six weeks.
How does the system handle document search and retrieval?
Medidata eTMF utilizes advanced search algorithms that allow users to locate artifacts based on content, title, and metadata. Powered by auto-naming capabilities, the system ensures content is standardized, making it simple to search and manage both regulated and non‑regulated content within a single interface.
Does Medidata offer training for its clients and partners?
Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.