We're excited to share that HumanTrue has been named a winner in the TransCelerate Protocol Review Challenge (hosted by ClinEco as part of the SCOPE Summit). The challenge asked vendors to demonstrate how digital protocols, specifically those built on the USDM (Unified Study Data Model), can transform the way clinical teams review and work with trial protocols.
The Problem with Protocol Review Today
If you've spent time in clinical operations, you know the pain. Protocol documents are long, complex, and filled with critical details that teams must extract by hand. Reviewers navigate these documents manually, pull out the pieces they need, and re-enter information into other operational systems. Medical writers, clinicians, data managers, and site teams all need different views of the same information, but the document doesn't adapt to them.
The TransCelerate challenge asked a simple question: what if protocols were structured data instead of static documents? What could protocol review look like then?
The Cold Start Problem
One of the biggest challenges with digital protocols is the "cold start" problem. Most clinical trial protocols today are written as unstructured documents (PDFs or Word files). To get to a digital protocol, you first need to convert that document into structured data. This is where HumanTrue's platform shines. Our AI-powered system reads protocol documents, extracts key information, and transforms it into USDM-compliant data. This structured data then serves as the foundation for all downstream applications, including protocol review.
Our Submission
We submitted a demonstration of the HumanTrue platform showing how we approach protocol review when the protocol is expressed as structured USDM data. Our submission focused on making protocol information accessible and actionable for the people who need it most.
One quick note about the video - the constraint was a 5 minute video, so as a result we talk pretty fast!
The video walks through how our platform works, and how things like the schedule of activities work for reviewers. We also show our protocol chat feature that lets reviewers ask questions directly against the study content. Given the limited time, we weren't able to show other features like our consistency checks against ICH guidelines, burden scoring for complexity analysis, recruiting materials, consent forms, and more. (For that, feel free to contact us!)
The Recognition
HumanTrue was recognized for Best User Experience (UX) Design for Protocol Review. The judges highlighted our intuitive Schedule of Activities interface and the way we enable protocol review through conversational AI, backed by consistency checks and optimization features like complexity and burden scoring. All of this is powered by our database of USDM-compliant protocols.
Why This Matters
This challenge reinforces something we believe deeply: the future of clinical trial operations depends on treating protocols as structured data, not documents. When protocol content is machine-readable and standards-aligned, teams can build tools that actually help reviewers do their jobs instead of adding more manual work.
We're grateful to TransCelerate and ClinEco for organizing this challenge and for their continued leadership in pushing the industry toward digital data flow. If you're interested in learning more about how we're applying these ideas, check out the video above or get in touch. You can also check out our company page on ClinEco's site.