BSI eTMF (electronic Trial Master File)

BSI eTMF is a comprehensive and powerful yet affordable solution for managing clinical trial documents. Available as a part of BSI CTMS or as a standalone application. This highly intuitive platform covers every facet of document management within clinical trials to ensure compliance with regulatory requirements and help companies be ready for audits and inspections.

BSI's solution offers a very user-friendly interface that prioritizes an intuitive user experience, thereby fostering seamless collaboration among study team members.

It is seamlessly integrating with the BSI CTMS system ensuring data consistency across your entire clinical trial ecosystem.

• Document Management - BSI eTMF presents a complete set of functionalities that support compliant document management for clinical trials.
• Monitoring and Reporting - BSI eTMF empowers users with flexible reporting, allowing personalized document reports to be easily configured and exported to Word or Excel.
• User Access and Permissions - Granting and managing access to BSI eTMF for study partners, inspectors, and auditors is straightforward. 
• Automated workflows - Automation allows streamlining of complex document workflows within the trial management process.
• Regulatory compliance - Ensuring regulatory compliance is paramount in clinical trials, and BSI eTMF addresses this by adhering to industry standards and regulatory requirements such as from 21 CFR Part 11, ICHGCP E6(R2) and GDPR (General Data Protection Regulation).
• Integration with other systems - The seamless integration of BSI eTMF the BSI CTMS system and EDC is a pivotal feature that ensures data consistency and traceability across the entire clinical trial ecosystem.