Protas Partners with Trial Interactive to Modernize Clinical Trial Documentation

As a new not-for-profit organization setting up foundational systems, Protas needed a document management solution that would align with their mission to make trials more efficient and accessible. Their aim is to make it  easier and cheaper to run large-scale studies in treatments for common conditions, which could ultimately improve the healthcare of millions globally.

Having previously worked with paper-based systems historically in the industry  the team knew firsthand the obstacles: storage and archiving issues, missing or misfiled documents, environmental costs and critically, the lack of direct access to site documents between monitoring visits.

They sought a partner who could provide both the technology and expertise to avoid the past  experience with traditional TMF and ISF systems in previous roles, particularly around real-time document access to investigator site documents and quality control.

Trial Interactive provided Protas with an electronic ISF system, delivering a user-friendly platform that transformed how sites and central teams manage GCP essential documentation. The implementation included comprehensive support from Trial Interactive's team, actively listening to feedback and helping shape the product roadmap based on real-world usage, improving the management of GCP essential documentation for future trials.

The system enabled remote document review, real-time upload capabilities across multiple sites, and immediate identification of issues like duplicate documents, allowing for instant retraining before problems could spread. Sites could upload documents directly without printing and filing, while central teams gained unprecedented visibility into documentation status, training records and other critical study documents without traveling to sites. This perfectly complemented their own end-to-end trial management platform, Cantata, which embeds Protas led principles to reduce site and participant burden, and increase overall trial quality.

• Achieved 100% site adoption with overwhelmingly positive feedback on user-friendliness
• Eliminated travel costs for document review, CRAs can now review ISFs remotely instead of only during site visits
• Accelerated site setup timelines through real-time document upload and review capabilities
• Enabled immediate detection and correction of documentation issues, preventing systemic problems
• Reduced environmental impact by eliminating paper-based filing systems and associated printing/shipping costs
• Provided multi-site access for staff working across locations, streamlining document management
• Improved documentation quality compared to previous paper-based experiences
• Saved significant time for site staff who no longer need to print and manually file documents