⎯⎯⎯ Captivate eTMF
Trial Master File solution for effortless document management
Document Management
Inspection-Ready Documentation
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.
Centralized Oversight & Integration
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.
Structured Lifecycle Tracking
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.
TMF Reference Model
Support for global TMF Reference Model indexing or custom taxonomy.
Metadata Capture
Consistent document metadata capture for reliable classification and search.
Configurable Filing
Folders, categories, and subcategories aligned to specific study needs.
Advanced Search
Full search and filter capabilities across documents and metadata.
Automated Versioning
Timestamped history of all document versions
Audit Trails
Tracking for uploads, revisions, approvals, and access
Lifecycle States
Clear differentiation between draft, final, and archived content
Rollback Support
Support for rolling back to prior versions when needed
Configurable Routing
Define automated document review and approval paths reflecting your SOPs.
Action Alerts
Automated alerts and reminders for pending review or approval actions.
Role-Based Review
Controlled access to review, approve, or annotate essential trial documents.
Collaborative Review
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
The Captivate Platform
Shared Study Context
Shared context with Captivate EDC and VDC modules for aligned workflows.
Centralized Visibility
Visibility into document status relative to key clinical milestones.
Unified Archiving
Unified export capability for archived trial master file packages.
Consistent Metadata
Consistent metadata and audit trails across all Captivate systems.
Cross-Study Dashboards
Completeness and review status across all studies
Global Filters
Search across studies, documents, and metadata seamlessly
Summary Reporting
Ready-to-use reports for operational leadership and QA
Regional Variations
Support for multi-region regulatory requirements
Choose Captivate
Standards-Aligned
Document organization and indexing
Version Tracking
Comprehensive trails and version history
Configurable Workflows
Reflects your real-world SOPs
Integrated Context
Linked across the Captivate platform
Compliance Ready
Built-in readiness for inspections
Ready to Learn More?
Discover how Captivate can support your clinical research needs. Our team is here to answer questions and show you what’s possible.