eTMFlex
The Next-Generation eTMF System for Clinical Trial Documentation
eTMFlex is a powerful and flexible software solution designed to manage all documentation related to a clinical trial in compliance with electronic Trial Master File (eTMF) standards. Built for adaptability and scalability, eTMFlex offers intelligent tools to organize and continuously evolve your trial’s document structure.
Dynamic Data Dictionary
At the core of the platform lies the Data Dictionary, an Excel file that defines the entire hierarchical structure of the trial’s document tree: folders, documents, metadata, and rules. Once the initial file is uploaded, the structure can be modified at any time through an update file, downloadable directly from the platform.
This update file keeps the original format and offers an intuitive way to make changes: green cells represent existing nodes that can be updated, and built-in formulas ensure every change is propagated wherever the node is used.
You can update names, descriptions, document/folder flags, comments, code templates, and symbolic links. Red cells indicate issues with symbolic links, with readable messages to guide correction.
Symlinks Across Document Trees
One of eTMFlex’s most advanced features is the support for symlinks—symbolic links that connect nodes from different trees within the same protocol. This allows for modular and non-redundant documentation structures.
Symlinks are defined directly in the Data Dictionary using a clear and flexible syntax. Upon import, the system associates each symlink with its target node, generating a coherent and fully navigable document tree.
Symlinked nodes behave just like regular nodes in the interface: users can navigate parent/child relationships seamlessly, even across separate document trees. The system handles path rendering intelligently to ensure a consistent user experience.
Custom Human Code Templates
Each node can be linked to a human code template, a powerful system for dynamically generating readable and consistent codes based on variables. Templates support conventions such as site codes, country codes, IMP references, or staff member identifiers.
Codes are automatically generated using the actual document tree structure and specific entity values, allowing for flexible and automated code management.
Advanced Milestone Management
eTMFlex includes robust tools for managing milestones, which can be configured per site, lab, or country. When creating a milestone, the user selects the entities involved, with write access limited to the permitted scope.
Milestones start in the "Created" state and can later be activated. Activation automatically generates the corresponding document nodes based on the Data Dictionary and the selected entities.
Once activated, milestones are only visible to users with access to at least one related node. Each user sees only the documents relevant to their assigned organizations. The system also supports milestone cloning, useful for replicating configurations across similar protocols or new studies.
Electronic Signature
eTMFlex integrates an electronic signature system compliant with international regulatory standards (21 CFR Part 11), allowing documents to be signed electronically directly within the platform. Each signature is uniquely associated with the user, recording the timestamp, role, and action. This ensures authenticity and integrity of all critical documents, simplifying the regulatory management of the trial.
Immutable Audit Trail
Every action in eTMFlex is recorded in a complete and immutable audit trail, tracking modifications, creations, deletions, and document access. The audit trail is accessible in real time and maintains a detailed history of who did what, when, and why. Thanks to this functionality, sponsors, CROs, and clinical sites can ensure transparency, regulatory compliance, and ease of inspection during both internal and external audits.
eTMFlex is ideal for CROs, sponsors, and clinical sites seeking a robust yet flexible tool that adapts to the unique structure of each trial and evolves with it. By combining an intuitive user interface with a technically sophisticated backend, eTMFlex sets a new standard for eTMF document management.
Visit the eTMFlex dedicated website for more information.