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All Electronic Trial Master File (eTMF)

What is Electronic Trial Master File (eTMF) software?

Electronic Trial Master File (eTMF) software is a document management system for clinical trials. It provides a centralized, secure repository for all trial-related documents and replaces traditional paper-based methods. eTMF software offer researchers a solution for organizing, storing, and accessing critical trial information. Researchers can also instantly share and review documents, track changes through detailed audit trails, and maintain a standardized document structure. This helps meets stringent Good Clinical Practice (GCP) guidelines.

By automating document workflows, reducing administrative burdens, and minimizing storage costs, eTMF software enables clinical trial teams to focus more on research and less on paperwork.

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Evident IQ eTMF

Stay in control of your trial with real-time access to study documents through the EvidentIQ eTMF. It’s easy to use and simple to manage. Build custom workflows to route documents Read More...
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Top Benefits of eTMF Software

Electronic Trial Master File (eTMF) software digitizes and organizes essential clinical trial documents, ensuring secure access, compliance, and audit readiness across the study lifecycle. Benefits include:

  • Centralized document management: Stores all trial documents in a structured, searchable digital repository.
  • Regulatory compliance: Supports compliance with ICH-GCP, FDA 21 CFR Part 11, and other global regulations.
  • Improved audit readiness: Maintains real-time completeness tracking and audit trails for inspections.
  • Faster document retrieval: Enables quick, role-based access to critical files from any location.
  • Enhanced collaboration: Facilitates secure sharing between sponsors, CROs, and sites.
  • Document version control: Automatically manages revisions and maintains document history.
  • Reduced administrative burden: Minimizes manual filing and tracking of documents.
  • Lifecycle visibility: Offers dashboards and metrics for monitoring TMF health and milestones.

 

Clinical Trial Software Market Size, Clinical Trial Software Industry Report, Clinical Trial Software Infographic

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clinical trial software ecosystem, clinical trial software landscape

betterclinical showcases over 400 clinical trial software

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