⎯⎯⎯ Captivate eTMF
Trial Master File solution for effortless document management
Captivate eTMF is a secure, standards-aligned electronic Trial Master File solution designed to help sponsors, CROs, and study teams manage essential trial documentation in a consistent, transparent, and inspection-ready manner.
Built to integrate with the broader Captivate clinical data platform, Captivate eTMF supports centralized oversight of regulatory and administrative artifacts while preserving traceability, compliance, and workflow flexibility.
Designed for real-world study operations, Captivate eTMF enables structured document organization, automated lifecycle tracking, and controlled access helping teams reduce administrative burden, improve oversight, and support audits and inspections with confidence.
Support for global TMF Reference Model indexing or custom taxonomy.
Consistent document metadata capture for reliable classification and search.
Folders, categories, and subcategories aligned to specific study needs.
Full search and filter capabilities across documents and metadata.
Timestamped history of all document versions
Tracking for uploads, revisions, approvals, and access
Clear differentiation between draft, final, and archived content
Support for rolling back to prior versions when needed
Define automated document review and approval paths reflecting your SOPs.
Automated alerts and reminders for pending review or approval actions.
Controlled access to review, approve, or annotate essential trial documents.
Support for functional teams to collaborate without version conflicts.
Designed to meet regulatory and privacy expectations across global trials while supporting audits without unnecessary friction.
Compliance with 21 CFR Part 11, Annex 11, and GDPR
Secure document storage and transmission
Role-based access control with detailed permission levels
Comprehensive audit trails for uploads and approvals
Shared context with Captivate EDC and VDC modules for aligned workflows.
Visibility into document status relative to key clinical milestones.
Unified export capability for archived trial master file packages.
Consistent metadata and audit trails across all Captivate systems.
Completeness and review status across all studies
Search across studies, documents, and metadata seamlessly
Ready-to-use reports for operational leadership and QA
Support for multi-region regulatory requirements
Document organization and indexing
Comprehensive trails and version history
Reflects your real-world SOPs
Linked across the Captivate platform
Built-in readiness for inspections
Discover how Captivate can support your clinical research needs. Our team is here to answer questions and show you what’s possible.
