Captivate eTMF (Electronic Trial Master File) is designed to help studies and sponsors efficiently organize and manage clinical trial documentation, ensuring smooth submissions at the conclusion of the data collection cycle. Built on the robust Captivate platform, it simplifies the complexities of trial documentation while maintaining the highest standards of privacy, security, and scalability.
Access & Security
Permission-based access control restricts document viewing and management to authorized personnel only
Role-based design with focus on user roles and permissions
Clear audit trail functionality for all document activities
Document Management
User-friendly workflows for folder creation, editing, and organization
Version control tracking document iterations
Upload/download capabilities with expiration date management
Document movement and organization tools
Compliance & Reporting
Global regulatory compliance: 21 CFR Part 11, HIPAA, GDPR, and Annex 11
Comprehensive reporting generating overviews of all study documentation
Scalable storage solutions with pre-signed links for secure file transfers