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

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

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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 CRF 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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