Reimagining The Protocol For The Future Of Research

By Cal Collins

Clinical trial protocols are the blueprints of research, yet they remain locked in static, text-based documents that must be manually reinterpreted across each system—Electronic Data Capture (EDC), Electronic Health Records (EHR), and more—introducing inefficiency and risk. Through our collaboration with the HL7 Vulcan Accelerator, we’re pioneering the use of structured, machine-readable protocols—specifically the FHIR Schedule of Activities (SoA)—to transform this outdated model.

OpenClinica's pilot demonstrates how a single digital protocol can automate and align operations across multiple systems. This approach enables consistent visit schedules, data pulls, and documentation without redundant setup. Building on the success of OpenClinica Unite, our scalable EHR-to-EDC solution is already in use at over 450 sites. By digitizing protocol logic, we reduce manual effort, improve data quality, and support global standards like ICH M11. Structured protocols represent a foundational shift—harmonizing the design and execution of trials across platforms. Adoption takes time, but the groundwork is in place.