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.

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Product screenshot, FICS study dashboard
Trusted by leading global pharma and biotech teams
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Platform architecture

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.

eTMF
EDC
CTMS
Feasibility
Safety
Monitoring
Data Extract
FICS Platform
One shared record · AI in every workflow
Startup
Operations
Data
Documents
Sites
Safety
Validation
Unified Trial Record
·
Workflow Engine
·
Regulatory Audit Trail
·
AI Intelligence
AI embedded across every workflow
One audit trail·No reconciliation·Amendments propagate automatically·AI governed inside regulated workflows
Lifecycle

One record from protocol to database lock.

Four connected domains cover the whole trial, each one writes to the same record the others read.

Study Startup
Trial Conduct
Data & Monitoring
Closeout
Study Startup
Feasibility & site selection
Site qualification
Budgets & contracts
Essential documents
Regulatory activation
Greenlight & workflow orchestration
Trial Operations
CTMS
eTMF & eISF
Clinical Interface
Patient & site portals
Safety workflows · IRT & supply
Sponsor–site collaboration
Clinical Data
EDC with protocol-driven study build
Intelligent edit checks
EMR-to-EDC automation
Continuous data-quality monitoring
Risk-based monitoring
Data cleaning & database lock
Validation & Quality
FICS Attest
FICS Catalyst
Risk-based validation
Traceability & evidence
Unified audit trails
Inspection readiness
AI

AI embedded in the work, not added as a chatbot.

Every output is source-grounded, reviewable, traceable, and governed within the platform.

Source-grounded
Reviewable
Traceable
Human oversight
Protocol-to-study build
Hand FICS the protocol and it drafts the complete study build, CRFs, visit schedule, and edit checks, ready for human review, with every element traceable to its source line.
Protocol
CRF set
Edit checks
Visit schedule
Intelligent edit checks
Generate and maintain edit checks grounded in the protocol.
Continuous data-quality monitoring
Every data point checked as it arrives, not at cleaning.
Risk & clinical monitoring
Surface site and patient risk signals as they emerge.
Clinical-operations intelligence
Ask operational questions; get source-grounded answers.
Document intelligence
Classify, file, and QC documents against the TMF plan.
EMR-to-EDC orchestration
Move source data into EDC without transcription.
AI-native validation
Author, execute, and evidence validation with AI assistance.
FICS Validation Cloud

AI-native validation infrastructure for regulated software and clinical systems.

Two products, one lifecycle, for FICS itself and for third-party regulated systems.

FICS Attest
System of record

The system of record for AI-native validation, the governance and evidence layer for your regulated systems.

Risk-based validation lifecycle
Traceability & evidence, end to end
Inspection-ready audit trails
Learn about Attest
FICS Catalyst
Productivity workspace

The AI productivity workspace for validation teams, author, execute, and document validation work faster.

AI-drafted scripts and protocols
Guided execution and capture
Evidence handed to Attest
Learn about Catalyst
Catalyst accelerates the work. Attest governs the lifecycle.
CRO services

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
Pi Health clinical operations team reviewing a study on FICS
Solutions

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.