Results

Proven in real clinical trials

Three case studies from trials run on FICS, each metric reported with its context and methodology.

Case study 01

Phase 1 in Australia, running today

A first-in-human oncology program for a lean biotech, delivered by Pi Health as CRO on FICS.

  • Study started December 2025, now at the final dose level
  • Quick, efficient recruitment, sites satisfied with the software
  • The partnership has been extremely successful and is now expanding to Phase 2 and to other assets

“Going back to using different systems for each study instead of FICS would be an absolute nightmare to manage.”

Head of Clinical Operations, Sponsor Biotech
26,348

data points collected, clean

10subjects enrolled in solid tumors, 2 cohorts cleared
5interim monitoring visits performed

“The work that the Pi Health team did was extraordinary.”

Director and Founder, Sponsor Biotech
Case study 02

Lead CRO on a global Phase 2 for a top-10 pharma

A global oncology study across the US, Europe, and Australia, running live on FICS today.

Also delivered during startup
  • 40+ sites completed feasibility questionnaires directly in FICS
  • Up to 37 days earlier insight into site responses
  • TMF filing automated, documents filed in seconds
  • User onboarding in 14 seconds versus days in legacy systems
  • Real-time sponsor and site visibility from day one
74 days
UK MHRA / REC / HRA approval
against a 120-day projection
99%
TMF filing accuracy
across 821 documents
2 days
Australia amendment approved
clean turnaround, no queries
~1 month
Site selection compressed
feasibility through selection

“Amazing work. This was a really tough one and we really thought it would not go through. A major victory given the MHRA's feedback.”

Senior Director, Global Medical Affairs, top-10 pharma sponsor
Case study 03

Full lifecycle: 61% faster trial execution

A Phase 2 immuno-oncology study for a global large-cap biotech company delivered end to end on FICS versus a traditional CRO and stack.

Study conduct duration
Study start to last subject enrolled
13 months →6.5 months
Study close-out duration
Last subject last visit to database lock
5.5 months →2 weeks
Time to clinical report
Database lock to tables, figures, listings
2 months →2 weeks
  • 7 months from first patient enrolled to drug marketing approval
  • Under 6 weeks to enroll 50% of target patients
  • Regulatory-grade: real-time, audit-ready data with no third-party conversion

Same protocol scope. Same regulatory bar. The time came out of the workflow, not the science.

20.5 → 8months

total study timeline vs. a traditional CRO & stack

Traditional CRO & stack20.5 mo
Pi Health + FICS8 mo
61%faster end-to-end trial execution

One trial. One shared record. One operating system.

See how these results would translate to your program.

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