Pi Health
Runs oncology and other clinical trials for sponsors as a CRO on its own AI-based trial platform.
Company basics
- HQ
- United States
- Founded
- 2021
- Delivery model
- Software plus service
- Pricing model
- Not disclosed
Scope
- Industries
- Healthcare
- Regions
- Asia, Australia, Europe, United States
- Languages
- unstated
About Pi Health
Pi Health develops FICS, which it describes as an AI-native operating system for clinical trial management, and also offers clinical trial execution as a contract research organization. The platform brings electronic data capture, clinical trial management, electronic trial master file, study startup, safety monitoring and risk-based monitoring into one shared trial record with embedded AI.
The company states its CRO services cover feasibility, startup, operations, data management and closeout, delivered by the people who develop the platform. Applied AI features listed include protocol-to-study build automation, edit checks grounded in protocol requirements, EMR-to-EDC data orchestration and real-time data quality monitoring. The site lists 21 CFR Part 11, GxP, SOC 2 and HIPAA among its compliance statements.
It is aimed at pharmaceutical and biotech sponsors, and demos are requested through the website.
What they do
- End-to-end delivery (you don't operate the tools)Source · checked 2026-09-29Full-service CRO running clinical operations, data, regulatory, safety on its own platform.
- Human review includedSource · checked 2026-09-29Outputs described as source-grounded and reviewable; study build ready for human review.
Pricing
- Pricing model
- Not disclosed
- Published starting price
- Not published
- Pricing page
- Not published
Evidence of outcomes
BOutcomes reported by the company or its investors.Company case studies at pihealth.ai/results: anonymized sponsors, 20.5 to 8 month timeline claim, 74-day UK approval; GSK collaboration on press page. Self-reported.
A: third-party verifiable outcomes · B: outcomes reported by the company or its investors · C: no publicly verifiable outcomes yet. Demos, forecasts and slogans do not count.
Our read
Editorial view based on public information — not an endorsement.
Capabilities
| Check | Status | Source |
|---|---|---|
| End-to-end delivery (you don't operate the tools) | Confirmed | Source · checked 2026-09-29Full-service CRO running clinical operations, data, regulatory, safety on its own platform. |
| Human review included | Confirmed | Source · checked 2026-09-29Outputs described as source-grounded and reviewable; study build ready for human review. |
| Signed off by licensed professionals (CPA, attorney…) | Not stated | — |
| Works inside your existing systems | Not stated | — |
| Private / on-prem deployment available | Not stated | — |
| API or data export | Not stated | — |
| Multilingual delivery | Not stated | — |
Commitments
| Check | Status | Source |
|---|---|---|
| Public delivery SLA | Not stated | — |
| Outcome-based pricing | Not stated | — |
| Refund / satisfaction guarantee | Not stated | — |
| Customer data not used for training | Not stated | — |
| SOC 2 | Confirmed | Source · checked 2026-09-29SOC 2 stated on legal page and footer; no report detail. |
| ISO 27001 | Not stated | — |
| HIPAA | Confirmed | Source · checked 2026-09-29HIPAA stated; legal page lists a Business Associate Addendum. |
| GDPR | Not stated | — |
| Named party responsible for outcomes | Not stated | — |
Funding
Over $30M Series A led by AlleyCorp and Obvious Ventures, with Invus Capital and oncology leaders (March 2024).Announcement
How we check
Every check below links to its source and shows when we checked it. "Not stated" means we found no public statement — it does not mean "no".
Other routes
Use a tool yourself
Get it implemented
Sources
- Company website: https://pihealth.ai/
- End-to-end delivery (you don't operate the tools): https://www.pihealth.ai/solutions
- Human review included: https://www.pihealth.ai/
- SOC 2: https://www.pihealth.ai/legal
- Funding announcement: https://www.nasdaq.com/press-release/pi-health-raises-over-$30m-in-series-a-to-revolutionize-cancer-care-and-clinical
Change history
- 2026-09-29 · Listed on Toolsfine