Faro Health
by Faro AI, Inc.
Agentic AI that turns clinical trial protocols from static documents into structured development intent
Faro Health is an AI platform for clinical development that models trial protocols as structured, machine-readable data instead of static documents, then layers agents over that model to design studies, author documents and automate study startup. It is built for biopharma clinical development, data management and medical writing teams who need to cut protocol rework and patient burden before a study ever reaches a site.
Faro Health, operating as Faro AI, Inc. and now branded at faro.ai, was founded in 2019 in San Diego by CEO Scott Chetham, previously Head of Clinical Research Operations at Verily Life Sciences. The company's premise is that clinical protocols have always lived in static, unstructured files, locking away their data and making downstream automation nearly impossible. Faro therefore builds proprietary clinical development data models and AI infrastructure that translate scientific, medical, regulatory and operational concepts into structured, machine-readable intent, so AI agents can reason across interconnected clinical workflows rather than parsing documents. The platform is organised into three areas: Study Design, which optimises protocols against real-time data and quantifies the impact of changes to the schedule of assessments; Document Authoring, which generates protocol drafts in minutes with medical writers retaining control of edits and approvals; and Workflow Automation, which drives automated EDC builds and digital data flow to compress study startup. Faro joined the Veeva Product Partner Program and built an integration that pushes the digital schedule of activities from Faro Study Designer straight into Veeva Vault EDC in a couple of clicks. The underlying method is peer-reviewed: a 2024 paper in Therapeutic Innovation & Regulatory Science describes redesigning and simplifying schedules of assessment and quantifying the impacts, applied to Merck protocols. Faro reports its platform has identified more than $300 million in potential cost savings, 200,000 potential patient hours avoided and over 1,500 potential RVUs avoided. On 26 August 2026 the company raised a $37.3 million Series B co-led by the Merck Global Health Innovation Fund and S32, with General Catalyst, Northpond Ventures, Polaris Partners, PTX Capital, Zetta and new investor Ankona Capital participating, bringing total funding to roughly $75.8 million. The platform is used by six of the world's ten largest pharmaceutical companies, on a team of around 70 people.
The head of clinical development operations or clinical data management at a pharma or biotech sponsor whose protocol amendments, schedule-of-assessment rework and EDC build cycles are the critical path to first patient in.
A protocol that exists as structured data, so design trade-offs are quantified before approval and the schedule of activities flows straight into EDC instead of being rekeyed.
At a Glance
- Category
- Industry & Government
- Pricing
- Subscription, Contact for pricing
- Target Market
- CIOs, Heads of Clinical Development, Clinical Data Managers, Medical Writers, Biometrics Leaders
- Deployment
- Cloud-only
- Founded
- 2019
- Headquarters
- San Diego, United States
- Team Size
- 51-200
- Customers
- Six of the world's ten largest pharmaceutical companies; individual names undisclosed
Key Features
- ✓Structured protocol data model
Converts unstructured protocol content into machine-readable clinical development intent that downstream systems and agents can act on.
- ✓Study Design optimisation
Quantifies the operational and patient-burden impact of schedule-of-assessment changes with real-time feedback during design.
- ✓AI document authoring
Generates protocol drafts in minutes while medical writers keep control of every edit, review and approval step.
- ✓Veeva Vault EDC integration
Sends the digital schedule of activities from Study Designer into Veeva Vault EDC in a couple of clicks.
- ✓Workflow automation for study startup
Automates EDC builds and digital data flow to compress the time between protocol approval and first patient in.
- ✓Agentic reasoning across workflows
Agents identify risks and inconsistencies across interconnected development processes rather than analysing single documents in isolation.
Capabilities
Use Cases
- •Protocol simplification
Redesign a schedule of assessments to cut unnecessary procedures and quantify the resulting savings in cost and patient hours.
- •Amendment avoidance
Surface design inconsistencies and feasibility risks before protocol approval, reducing the substantial amendments that stall enrolment.
- •Accelerated study startup
Push structured trial design into Veeva Vault EDC so data managers skip weeks of manual study build work.
- •Portfolio-wide standardisation
Apply consistent structure and design standards across many concurrent studies and therapeutic areas within one sponsor.
- •First-draft document generation
Produce a structured protocol draft from the study concept in minutes so writers edit rather than start from a blank page.
Ideal For
Best For
- ✓Quantifying patient burden and site feasibility while a protocol is still being designed
- ✓Generating first-draft protocol documents with medical writers retaining editorial control
- ✓Cutting EDC build time by sending a digital schedule of activities into Veeva Vault EDC
- ✓Reducing protocol amendments by testing schedule-of-assessment changes before finalisation
- ✓Standardising protocol structure across a portfolio of studies and therapeutic areas
Not Ideal For
- ✗Sponsors standardised on Medidata Rave or an in-house CTMS, since the publicly documented integration depth is essentially Veeva Vault EDC and other connections mean integration work
- ✗Organisations that will not put protocol IP into a vendor tenant, because the platform is cloud-only with no self-hosted option
- ✗Small biotechs running one or two studies, where an enterprise clinical platform and its validation overhead will not pay back against contract medical writing
- ✗Teams that need published, independently verified ROI before purchase — Faro's headline savings figures are self-reported and framed as potential rather than realised
Deployment
Market & Ratings
Six of the world's ten largest pharmaceutical companies; individual names undisclosed
Market Analysis
Pros
- ✓Six of the ten largest pharmaceutical companies already run the platform, the hardest proof point to manufacture in clinical software
- ✓The core method is peer-reviewed — a 2024 Therapeutic Innovation & Regulatory Science paper on redesigning schedules of assessment, applied to Merck protocols
- ✓Structured protocol data unlocks real downstream automation, with the Veeva Vault EDC integration sending the schedule of activities into study build in a couple of clicks
- ✓A SOC 2 Type II examination was completed with a clean opinion and no noted exceptions, audited by Sensiba San Filippo
- ✓Merck's Global Health Innovation Fund co-led the Series B, a strategic signal from the customer side of the market
Cons
- ✗Faro's impact figures — over $300M in cost savings, 200,000 patient hours avoided — are self-reported and explicitly framed as potential rather than realised outcomes
- ✗No named customer references are public; 'six of the top ten pharma' is unattributed, so buyer diligence has to happen under NDA
- ✗No G2, Capterra, TrustRadius, Reddit or Hacker News presence, so there is no independent practitioner review of the product anywhere
- ✗The publicly announced SOC 2 Type II attestation dates from January 2023 and there is no public evidence of HIPAA, ISO 27001, GDPR or 21 CFR Part 11 validation documentation a sponsor's quality group will demand
- ✗Documented integration depth is essentially Veeva Vault EDC; sponsors on Medidata Rave or an in-house CTMS should expect integration work
- ✗Cloud-only with no self-hosted option, a hard stop for the minority of sponsors that will not place protocol IP in a vendor tenant
Pricing
Enterprise
Contact for pricing
- ✓Study Design module
- ✓Document Authoring module
- ✓Workflow Automation and automated EDC build
- ✓Veeva Vault EDC integration
- ✓SOC 2 Type II controls
Faro publishes no pricing at all — no seat bands, no per-study rates, no public tiers. It sells enterprise subscriptions directly to biopharma sponsors through the long, committee-driven procurement cycle typical of clinical systems. Because the platform sits inside a GxP-regulated workflow, buyers should budget a formal vendor-qualification and computer-system-validation exercise alongside the licence itself.
Security & Compliance
Connect
Sources
This page was written from 5 sources, 3 on domains other than faro.ai.
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