BSI eTMF

The BSI eTMF is an advanced electronic system tailored for managing trial master files across various sectors such as pharmaceuticals, biotech, MedTech, and academic research. It offers a streamlined interface and supports comprehensive functionality needed for efficient trial management.

This electronic platform assures users of audit and inspection readiness, incorporating regular updates in response to evolving market conditions and regulatory requirements. Developed in collaboration with existing users, it ensures affordability without compromising on power.

The BSI eTMF facilitates seamless clinical trial management from startup through closure, offering customizable document plans and real-time tracking of document creation, review, and approval processes. Its compliant design adheres to 21 CFR Part 11, ICH-GCP E6(R2), EMA/INS/GCP/112288/2023, and GDPR standards, safeguarding patient data.

Key Features:

• Comprehensive Functionality: Supports varied trial master file structures and offers controlled access to study partners.
• User-Friendly Interface: The HTML5 web-based design provides an intuitive and pleasant user experience.
• Seamless Integration: Quick to implement with predefined configurations for medical device and pharmaceutical studies.
• Cost Efficiency: Provides a low total cost of ownership with minimal training and operation costs.
• Collaborative Capabilities: The BSI Portal allows efficient document exchange and collaboration with study sites.
• Secure Data Handling: Meets stringent regulatory and data protection standards.
• Controlled Access: Offers secure and efficient access for sponsors, CROs, sites, vendors, auditors, and inspectors via sophisticated rights management.

The system's integration into daily operations enhances the efficiency of managing and storing trial documents, all while ensuring compliance and reducing dependency on legacy systems.