Protocol First

The Protocol First platform is a Next-Gen EDC / CDMS; an end-to-end Clinical Trial Execution System designed from the ground up for today’s complex, oncology and precision medicine trials; whether single trials or within a Master/Umbrella/Platform program. Protocol First exports in real-time to SDTM and acquires data directly from EHR systems through FHIR. Founded in 2015, and currently working with one of the top 5 CROs and 5 of the top 20 pharma/ biotechs, Protocol First (P1) has changed the paradigm of data entry, by integrating EHR-EDC, and allowing clinical data to be natively collected and exported in SDTM. The P1 system not only radically reduces initial EDC build timelines (80% faster on average), but also drastically cuts down amendment implementation/ validation and on-site monitoring tasks. The platform’s architecture is fundamentally different from legacy EDC and EHR, and was designed from the ground up, to specifically avoid the baked-in flaws of those systems. P1 utilizes a proprietary eProtocol format, which can model any trial design – basket, master, platform, umbrella etc in days, not months.