Electronic Trial Master File (eTMF)

Rethink your study document management strategy with TrialKit
When it comes to today’s clinical trials, eTMF’s predecessors (paper-based file storage and common content management systems) create unnecessary hurdles to regulatory compliance and inspection readiness. It’s time to advance to an approach that enhances efficiencies, ensures Good Clinical Practice (GCP), and consolidates your documents into a central location. TrialKit’s eTMF solution enables anytime, anywhere management of essential documents directly integrated with the rest of the TrialKit ecosystem.
Take a product tour of TrialKit eTMF
An accessible and unified eTMF solution
TrialKit offers electronic trial master file technology that is unified with the entire platform and available on both the web-based and native mobile apps. As a part of TrialKit’s cloud-based ecosystem, real-time access to documents and truly remote collaboration is possible when managing your operational and study documents.
Access and manage all essential documents and associated tasks in one centralized system along with other study activities.
Integrate eTMF as a component of the TrialKit data and study management platform (EDC, ePRO, eConsent, RTSM, Coder, etc.) or use as a standalone app.
Access eTMF with TrialKit’s native mobile app for iOS and Android to utilize all the functions available on the web while on-the-go.
Account administrators have the ability to designate which users can view contents and change contents within eTMF using the same admin capabilities present in all other TrialKit modules, further establishing secure access and compliance.
Allow designated site personnel and study team members to access, review, edit, sign and exchange essential site documents in a centralized platform.
TrialKit eTMF enables users to define their own folder structure, change folder and file properties and maintain all submissible data in a secure, central cloud database.
Move files to or from third party applications by leveraging TrialKit’s RESTful API.
Save resources by eliminating the need to store, review, and approve clinical documents in an external system or in paper filing systems.
A template of DIA’s recommended file folder and documentation structure and contents, based on DIA’s Trial Master File Reference Model v3.2.1, is included.
All transactions and changes in TrialKit eTMF are logged in a verifiable and reportable audit trail, including file versioning information.
Learn even more about TrialKit eTMF by visiting the Help Center
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