What Pi Health does

Pi Health is a Cambridge, Massachusetts-based health-technology company founded in March 2024 that builds FICS (Front-End Interoperable Capture Software), an AI-native clinical trial operating system unifying EDC, CTMS, eTMF, eISF, and safety into a single shared data record with AI embedded at every workflow stage. The platform is extended by add-on modules — FICS Encoder (AI medical coding against MedDRA and WHODrug), FICS Attest (AI-powered GxP validation and 21 CFR Part 11 compliance), and EMR-EDC Orchestrator (AI-orchestrated EMR-to-EDC automation over HL7, FHIR, and LOINC). Pi Health serves pharmaceutical and biotechnology sponsors and, secondarily, contract research organizations, addressing fragmented legacy clinical trial stacks, slow study conduct, and high validation overhead. The company operates a hybrid business model combining SaaS subscription licensing of the FICS platform with fully outsourced clinical research services delivered as an AI-native CRO, currently anchored by a Master Clinical Services Outsourcing Agreement with GSK for a global Phase II oncology trial and a strategic partnership with Australian biotech Filamon for an anti-inflammatory cancer program.

Name

Pi Health

Legal name

Pi Health Inc.

Website

https://pihealth.ai

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

51–100 employees

Short description

Pi Health is a Cambridge, MA-based health-technology company that builds FICS, an AI-native clinical trial operating system unifying EDC, CTMS, eTMF, eISF, and safety, serving pharmaceutical and biotechnology sponsors as both a SaaS platform and an AI-native CRO.

Ownership category

akta.pro rank

Product category

Clinical Trial Software (eClinical Solutions)

NAICS

Custom Computer Programming Services (541511), Scientific Research and Development Services (5417)

SIC

Services-Prepackaged Software (7372), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Electronic Data Capture (EDC) Platforms (HLACAOAA)

akta.pro secondary industries

Clinical CROs (Phase I–IV) (HLAGAAAA), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH)

Keywords

• Clinical trial software
• Electronic data capture
• Clinical trial management
• AI medical coding
• Contract research organization

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices10 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Clinical Research Services: Pi Health operates as an AI-native contract research organization (CRO) providing fully outsourced clinical research services, including site selection, subject enrollment, study execution, real-time monitoring, and regulatory submissions.
2. FICS Platform Subscription: SaaS subscription model for the FICS clinical trial platform accessed through subscription agreements. Platform includes EDC, CTMS, eTMF, Safety, Encoder, FICS Attest, and EMR-EDC Orchestrator modules.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Pi Health provides FICS (Front-End Interoperable Capture Software), an AI-native operating system for global drug development that unifies EDC, CTMS, eTMF, eISF, and Safety modules into a single intelligent platform with a shared data layer. The company also operates as an AI-native contract research organization (CRO), delivering fully outsourced clinical research services including site selection, patient enrollment, study execution, real-time monitoring, and regulatory submissions for oncology clinical trials.

Product overview

Pi Health offers FICS (Front-End Interoperable Capture Software), an AI-native operating system for global drug development that unifies previously fragmented clinical trial systems into a single intelligent platform. The core FICS platform integrates EDC (electronic data capture), CTMS (clinical trial management), eTMF (trial master file), eISF (investigator site file), and Safety modules into one unified system with a single data layer, eliminating cross-system reconciliation. Additional add-on modules include FICS Encoder (AI-powered medical coding using MedDRA and WHODrug), FICS Attest (AI-powered GxP validation and 21 CFR Part 11 compliance), and EMR-EDC Orchestrator (AI-orchestrated EMR-to-EDC automation using HL7, FHIR, and LOINC standards). The platform embeds AI throughout workflows for protocol-driven study builds, real-time safety signal detection, automated document classification, predictive enrollment modeling, and conversational clinical operations. Pi Health operates as both a software provider and a contract research organization, delivering fully outsourced clinical research services powered by the FICS platform.

Differentiator

Problem solved

Functional benefit

Brands

• FICS: AI-native clinical trial operating system platform that unifies EDC, CTMS, eTMF, eISF, and safety into a single workflow-driven system.

Products and services

• FICS (Front-End Interoperable Capture Software) AI-native operating system for global drug development that unifies fragmented clinical trial systems (EDC, CTMS, eTMF, eISF, Safety) into a single intelligent platform with a shared data layer, powering faster, higher-quality trials from study startup through closeout.
• FICS EDC AI-native electronic data capture system with protocol-driven study builds, intelligent edit checks, and real-time data validation. Captures regulatory-grade data at point of entry and shares it across the FICS platform with built-in 21 CFR Part 11 compliance and EMR-EDC automation.
• FICS CTMS Next-generation clinical trial management system unifying study planning, site management, milestone tracking, and operational oversight. Deeply integrated with EDC, eTMF, and Safety. Features workflow-driven execution, real-time sponsor visibility, AI-powered predictive enrollment modeling, and risk-based monitoring.
• FICS eTMF Fully integrated electronic Trial Master File that eliminates manual document filing. Documents generated from CTMS, EDC, and safety workflows are automatically classified and filed into the correct TMF structure. Features AI-powered document classification, quality checks, and real-time completeness dashboards.
• FICS Safety Integrated adverse event capture, signal detection, and safety reporting within the clinical trial workflow. Safety data originates from the same unified data layer as EDC and CTMS, enabling earlier signal detection, real-time dashboards, and automated narrative generation with AI assistance.
• FICS Encoder AI-powered medical coding tool that automates classification of adverse events, medications, and medical history using MedDRA, WHODrug, and custom dictionaries. Operates directly on FICS EDC data, eliminating export-code-reimport cycles with AI-assisted coding suggestions, auto-coding, and audit trail from verbatim term through final coded term.
• FICS Attest AI-powered validation tool for GxP compliance that auto-generates validation documentation, executes traceability mapping, and maintains 21 CFR Part 11 audit trails natively. Consolidates eQMS, e-signatures, validation lifecycle, and audit trail into a single in-house platform, reducing validation time from weeks to days.
• EMR-EDC Orchestrator AI-orchestrated connector that automates data flow from electronic medical records into EDC systems. Built on HL7, FHIR, and LOINC standards, it extracts both structured and unstructured EMR data and maps it into GxP-compliant EDC fields. EMR-agnostic and EDC-agnostic.
• Clinical Research Services (CRO Services) Fully outsourced clinical research services as an AI-native contract research organization, including site selection, subject enrollment, study execution, real-time monitoring, and regulatory submissions. Powered by the FICS platform and delivered for pharma and biotech sponsors conducting clinical trials.

Quantifiable outcome

• 61% faster trial execution (study conduct from 13 months to 6.5 months; close-out from 5.5 months to 2 weeks; clinical report from 2 months to 2 weeks)
• +4 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability13 records

Feature11 records

Partnerships

Two partnerships are on record, tiered flagship and core.

• GSKflagshipStrategic or Co-development Partner · 25 September 2025Master Clinical Services Outsourcing Agreement for worldwide Phase II oncology trial. Pi Health leverages FICS platform to oversee site selection, subject enrollment, study execution, real-time monitoring, and regulatory submissions. Claims capability to accelerate study conduct by 50%. Collaboration aims to streamline inefficiencies in clinical trials and bring innovative cancer treatments to patients more quickly.
• FilamoncoreStrategic or Co-development Partner · 4 September 2025Strategic partnership with Australian clinical-stage pharmaceutical company to advance clinical development of innovative anti-inflammatory medications targeting age-related chronic inflammatory conditions. Pi Health provides clinical trial technology and management services supporting Filamon's expanding drug development pipeline.

Scale indicators5 records

Recent moves6 records

Emerging players

• Castor: Cloud-native EDC platform serving academic, biotech, and mid-market pharma sponsors with a self-serve plus enterprise motion; a direct EDC competitor targeting the same FICS customer segments.
• Medrio: EDC, ePRO, and eConsent platform focused on Phase I–III trials with mid-market and biotech sponsors; competes on speed of study build and ease of deployment, similar to FICS's positioning.
• Thread Research: Decentralized clinical trial technology platform with eCOA, telehealth, and patient engagement; an adjacent emerging player pursuing AI-enabled trial operations similar to Pi Health's vision.

Direct peers

• Medidata (Dassault Systèmes): Industry-leading Rave EDC, CTMS, eTMF and clinical analytics platform used by most top-20 pharma sponsors; the closest direct competitor to FICS across the same product categories (EDC, CTMS, safety).
• Veeva Systems: Veeva Vault CTMS, Vault EDC, Vault eTMF and Vault Safety offer an enterprise-grade unified clinical platform; competes head-to-head with Pi Health for pharma sponsor relationships.
• Clario: Provides eCOA, EDC, medical imaging, and endpoint adjudication for clinical trials, with a deep enterprise sponsor footprint; comparable to FICS in unifying trial data capture and management.
• Signant Health (formerly CRF Health / Clinical Ink): Provides EDC, eCOA, ePRO, and clinical supply solutions for clinical trials; competes on AI-enabled data capture and unified workflows similar to Pi Health's FICS platform.

Broad incumbents

• Oracle Clinical One: Oracle's unified clinical trial platform combining EDC, RTSM, and CTMS capabilities as part of a broader life-sciences portfolio; targets the same enterprise pharma buyer with deep IT integration.
• IQVIA: World's largest CRO with proprietary clinical technology platforms (e.g., IQVIA EDC, Orchestrated Patient Engagement); operates as both technology provider and CRO like Pi Health, but at vastly greater scale.
• ICON plc: Global CRO and clinical technology provider post-PRA merger, with proprietary Firecrest and other trial platforms; comparable hybrid services-plus-technology model targeting pharma and biotech sponsors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries10 records

Funding overview

Funding rounds2 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pi Health