Tech-Enabled CRO

A modern CRO, powered by our own AI-native operating system

Pi Health combines experienced clinical delivery with FICS, our AI-native clinical trial operating system, to run startup, conduct, data, safety, and closeout as one connected program. One team. One source of truth. Fewer handoffs, faster decisions, and real-time visibility from first site to database lock.

Discuss Your StudySee the results
Pi Health clinical operations team reviewing a study together, with a CRO excellence framework on the whiteboard behind them.
500+
Clinical trials delivered across our team’s careers
50+
Regulatory approvals our team has helped bring across the line
4
Regions of in-house delivery: US, EU, Australia, Asia
1
Unified system from first site to database lock

What we do

  • Full-service CRO delivery: clinical operations, monitoring (CRAs), data management, biostatistics and programming, regulatory, medical monitoring, safety and pharmacovigilance, and project management
  • FICS: our AI-native trial operating system, replacing the fragmented stack of CTMS, EDC, eTMF, ISF, feasibility, and monitoring tools
  • Global reach: in-house teams across the US, EU, Australia, and Asia, delivering trials wherever your program needs to run

One connected program

From first site to database lock

  1. Study startup
  2. Trial conduct
  3. Clinical data
  4. Safety
  5. Closeout
One shared record on FICS

Capability

Full-service CRO capability, in house

Every function you would otherwise contract across three or four vendors, delivered by one team on one system.

Clinical Operations

Study startup, site activation, and day-to-day trial conduct.

Monitoring (CRAs)

In-house CRAs in the US, EU, and Australia; risk-based and on-site monitoring.

Data Management

Study build, edit checks, cleaning, and database lock on FICS.

Regulatory

IND, CTA, CTN, ethics submissions, and health authority interactions.

Medical Monitoring

Oncology medical monitors, eligibility review, and dose escalation support.

Safety & Pharmacovigilance

SAE processing, expedited reporting, and safety surveillance.

Project Management

Integrated planning, cross-functional coordination, risk management, and sponsor governance.

Biostatistics and Programming

Statistical strategy, analysis planning, programming, data outputs, and support through final reporting.

Global footprint

United States
Clinical ops, data, regulatory, safety, and CRAs
Europe
Clinical ops, regulatory, and CRAs
Australia
Clinical ops and CRAs, with a Phase 1 site network
Asia
Delivery through established partnerships

One team. One system. Your whole trial.

See how Pi Health runs trials end to end on FICS, from first site to database lock.

Discuss Your Study