Trial Master File
Instant safe access to your clinical data from any place in the world


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

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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.
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