Electronic Trial Master File Software for Clinical Research
Organize clinical trial documents, version history and quality workflows with AIClinTrack’s eTMF foundation for sponsors and CROs — with access control and audit-ready activity records.
A structured foundation for clinical trial documents
The AIClinTrack eTMF foundation helps sponsors and CROs organize trial master file documents with version control, access control and audit-ready activity records. It provides readiness-oriented oversight to support — not replace — your inspection-preparation processes.
Structured document organization
Organize clinical trial documents in a structured way so teams can find essential records quickly.
Document version history
Maintain version history for documents so the current and prior versions remain traceable.
Access control
Role-based access controls help ensure the right people can view and manage the right documents.
Document QC workflow
Move documents through a quality-control workflow to support consistent document handling.
Study & site document context
Keep documents in the context of their study and site for clearer organization and oversight.
Audit-ready activity records
Retain activity records for document actions to support audit-ready workflows.
From document organization to readiness-oriented oversight
The eTMF foundation supports a structured document workflow that keeps version history and access control consistent.
- 1
Organize documents
Structure documents by study and site so essential records are consistently filed.
- 2
Control access
Apply role-based access so only authorized users can view or manage each document.
- 3
Run document QC
Move documents through a quality-control workflow with version history maintained throughout.
- 4
Maintain readiness
Retain audit-ready activity records that support your inspection-preparation processes.
For sponsors, CROs and clinical document teams
Trial master file management should support the teams responsible for essential documents. The AIClinTrack eTMF foundation is built with these use cases in mind.
Sponsors
A structured, version-controlled foundation for organizing essential clinical trial documents across studies.
CROs
Manage clinical documents on behalf of sponsors with role-based access and readiness-oriented oversight.
Clinical document & QC teams
Move documents through QC with version history and audit-ready activity records in one place.
Support for inspection readiness — without overclaiming
No software can guarantee inspection outcomes. The AIClinTrack eTMF foundation provides structured organization, version history and audit-ready activity records that support your own readiness and quality processes.
- Structured document organization by study and site context.
- Document version history to keep records traceable.
- Audit-ready activity records that support inspection preparation.
Frequently asked questions about the eTMF foundation
Continue exploring the platform
See the AIClinTrack eTMF foundation
Request a demo to see how sponsors and CROs organize clinical trial documents with version control and audit-ready records.