TMF

Trial Master File

All project documentation is stored in one place with shared access

Easy access to all documents
Real time folders completeness statistics
Access control
Access through WebDAV
Document and folder approval process support
Folder structure templates
Adjustable change notifications

Benefits and features

Document template creation

TMF template creation. Ability to copy file structure and access rights into other projects. Folders structure templates, placeholders for standard documents, site-repeatable and country-repeatable folders
Reporting, tracking and versioning in TMF

Customizable notifications set up for change tracking, folder completion and list of pending TMF activities. Real time completeness statistics per folder, folder completion management
Batch file import and export

The system allows to import and export all files in a folder at the same time. To upload files just drag and drop them to the TMF window. No need to download documents, work with the documents in a browser window
21 CFR Part 11 compliance

Audit Trail functionality embedded in TMF allows to track all changes in the system; the system is validated and tested in accordance with all 21 CFR Part 11 requirements
Safe cloud storage

Web access with no installation needed from any device anywhere in the world

Stiris would highly recommend Flex Databases as a client‐focused company with a technology that delivers on its promise and their team are a pleasure to deal with.

Amanda Carrera. Vice President, Stiris Research Inc.

TMF

Trial Master File

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