eTMF

ResearchManager eTMF is a digital Trial Master File solution designed for clinical research organisations, including CROs, sponsors, universities, and healthcare institutions. It supports secure, structured digital documentation management within clinical studies, combining integrated eISF functionality with validated electronic signatures to enable digital signing, automatic archiving, and fully traceable document storage.

The platform is part of the broader ResearchManager Clinical Research Suite and is certified to ISO 27001 and NEN 7510, and compliant with GCP, GDPR, FDA 21 CFR Part 11, ICH-GCP, and HIPAA. According to the vendor, it can reduce storage costs by up to 60%, improve document and signature traceability by up to 80%, and accelerate audit preparation by up to 50%.

TMF Structure and Configuration

• Supports the CDISC TMF Reference Model as a structural basis
• Document structure can be freely configured per study or adapted to specific study needs
• Suitable for sponsor, CRO, and academic study types
• Configurable document categories and metadata per protocol
• Version control and retention periods set per document type
• Real-time visibility into document completeness

Workflows, Electronic Signatures, and Archiving

• Structured document workflows with defined roles and responsibilities
• Validated electronic signatures for regulatory-compliant digital approval
• Automatic archiving of documents after signing, including version history and retention terms
• Full audit trail covering all actions within the system
• Documents are stored in a traceable, inspection-ready state

Integrated eISF and Site Collaboration

• Each investigator site has access to its own digital Investigator Site File within the same environment
• Sites can independently upload, manage, and sign documents
• Sponsors retain real-time insight into document status per site
• Reduces email traffic and accelerates document exchange between sites and sponsors
• Controlled access for external research centres

Compliance, Security, and Integrations

• Role-based access rights
• Single Sign-On (SSO) support
• Two-factor authentication
• Compliant with FDA 21 CFR Part 11 and ICH-GCP
• Secure data storage in accordance with ISO 27001, GDPR, and HIPAA
• Import and export capabilities in multiple formats
• REST API available for reading and writing data

ResearchManager eTMF is used by more than 200 organisations and has been in active use for over 13 years. It is recognised as a Momentum Leader on G2 in the clinical research category. The tool is available as part of the ResearchManager Clinical Research Suite alongside CTMS, EDC, RTSM, eConsent, ePRO, and other clinical operations modules.