Technology
Secure Document Exchange
Accelerate study startup via end-to-end integration and automated seamless exchange of research documents between sites, sponsors, and contract research organizations (CROs).
Key Features
- Centralized document management and communication
- Seamless distribution and monitoring of study documents
- 21 CFR Part 11 compliance
- Support for global, regional, or site-specific document requests
- End-to-end integration with sponsor electronic trial master file (eTMF) and site electronic investigator site file (eISF)
Streamline Collaboration Across Sponsors and Sites
End-to-end Document Management
All regulatory documents, whether originating from a sponsor or site, can be securely managed, signed, and exchanged. The integration ensures seamless transfer to the appropriate long-term storage, such as the sponsor’s eTMF or the site’s eISF, without needing users to leave their systems.
Centralized Management and Tracking
Documents and associated metadata are centrally managed, allowing for real-time tracking and distribution across global sites. This streamlines document handling, ensures the latest versions are always available, reduces the risk of errors, and improves version control.
Faster Study Startup
Accelerate communication and collaboration between sites, sponsors, and CROs by minimizing manual processes. With automated notifications and centralized document handling, study teams can move faster and maintain audit readiness from the outset.
Regulatory Compliance
Ensure 21 CFR Part 11 compliance across systems, while maintaining data integrity and security. The solution is adaptable to any technology infrastructure, making it a flexible option for sponsors, sites, and CROs.
Testimonial
At the outset of our multi-cohort global Phase II oncology study, our reliance on generic document management systems resulted in managing over 300 emails per day across our study teams and site staff. We implemented Advarra’s Longboat technology to centralize and streamline document distribution and collaboration with our sites throughout the rest of the study. Longboat made it easy to distribute critical regulatory documents, provide high-level study updates, and monitor acknowledgment of receipt without email, ensuring efficiency, better version control, and improved compliance.
