Effortless Study Document Management
Captivate® eTMF
Streamline Document Organization and Compliance. 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, eTMF simplifies the complexities of trial documentation while maintaining the highest standards of privacy, security,and scalability.
Captivate® eTMF includes efficient role-based design with a focus on user roles and permissions, Captivate® eTMF ensures that study administrators and sponsors retain complete control over document access and management. From creating nested folder structures to tracking document version histories, Captivate® eTMF is built to optimize trial workflows and maintain a clear audit trail.
Captivate® eTMF Features
- Permission-based access control ensures only authorized users can view and manage study files
- User friendly workflows make it easy to create, edit, organize, and move folders and documents
- Version control allows for tracking document versions with upload and download functionalities, including expiration dates
- Generate comprehensive reports of all study documents for streamlined oversight
- Safeguard your trial files using scalable storage solutions with pre-signed links for secure uploads and downloads
- Meets global regulatory standards, including 21 CFR Part 11, HIPAA, GDPR, and Annex 11 ensuring your trial is compliant