The AI-Native Operating System for Clinical Trials
FICS unifies study startup, clinical operations, site and patient workflows, clinical data, trial documents, monitoring, and validation on one shared record, from protocol to database lock.

Replace the clinical-trial stack with one operating system.
The point solutions you run today (CTMS, EDC, eTMF, safety, monitoring) converge into one platform on one shared trial record, with AI streamlining every workflow. Nothing reconciles because nothing is separate.
Proven in real clinical trials.
Every claim below links to a case study with context and methodology.
One record from protocol to database lock.
Four connected domains cover the whole trial, each one writes to the same record the others read.
AI embedded in the work, not added as a chatbot.
Every output is source-grounded, reviewable, traceable, and governed within the platform.
AI-native validation infrastructure for regulated software and clinical systems.
Two products, one lifecycle, for FICS itself and for third-party regulated systems.
The system of record for AI-native validation, the governance and evidence layer for your regulated systems.
The AI productivity workspace for validation teams, author, execute, and document validation work faster.
Your study, run by the team that built the operating system.
Pi Health's CRO services deliver trial execution on FICS itself, feasibility, startup, operations, data, and closeout, from the people who build the platform your study runs on.
Explore CRO Services
Adopt it end-to-end, or one module at a time.
FICS deploys alongside your existing systems, start where the need is, expand when it proves itself. Every module joins the same shared record.
One trial. One shared record. One operating system.
Request a demo and see FICS on a real protocol, from startup through database lock.
