ProtoPulse

ProtoPulse is a web app with an AI-assisted rules engine that helps clinical trial sites and sponsors catch protocol deviations early, while there’s still time to prevent repeat errors. It ingests key study documents (protocol, ICF, visit schedule, lab manual) and maps them into a structured checklist by visit and procedure. Site staff log what actually happened (or sync from EDC exports), and the app flags mismatches: wrong window, missing assessments, prohibited meds, late labs, or consent timing issues. It generates deviation narratives in sponsor-preferred formats and produces trend dashboards for monitors and QA. This is not a replacement for EDC/CTMS; it’s a deviation prevention layer that’s lightweight, fast to deploy, and focused on operational reality. Expect heavy compliance work (21 CFR Part 11, audit trails) and slow enterprise sales, but the value is tangible when a study is bleeding deviations.