Flagship platform

Proto AI

From first hypothesis to validated eCRF — authored, parsed and checked in days, with every value traceable to its source.

Proto AI now covers the whole protocol lifecycle. Protocol Authoring drafts the study itself from an evidence-grounded blueprint; Parse reads it, Forms writes the eCRF spec your EDC can ingest, and Validate checks live data against protocol-defined rules — with a human decision gate on every output. It does not replace clinical expertise. It removes the typing.

Book a live demoWays to evaluate
How it works

What happens to a protocol?

01
Proto Parse
Ingests the protocol and supporting documents — OCR plus transformer models — and returns structured JSON, XML and Markdown instead of 300 pages of prose.
02
Proto View
Every extracted entity is reviewed and corrected in one interface, with each value linked back to the exact page and line it came from.
03
Proto Forms
Generates the standards-compliant eCRF specification — CDASH and SDTM — and exports annotated Excel, JSON or ODM-XML straight into your EDC.
04
Proto Validate
Runs protocol-defined checks on live data: pass, fail or warning, each with its rule source, a suggested action and a QA flag.
New module · Protocol Authoring

Start before the protocol exists.

Most protocol risk is locked in at the writing desk. Protocol Authoring replaces the blank document with a guided, evidence-grounded workspace — hypothesis to an early-phase protocol draft in hours, not months, born structured, cited and compliance-checked.

See it on your study →
01
A blueprint, not a blank page
A guided conversation captures phase, indication, endpoints, hypothesis and design philosophy — a machine-readable blueprint of the study before a word is drafted.
02
Evidence-grounded references
The system researches comparable protocols by indication, phase, endpoints and population — and explains what worked, what caused friction, and why. You lock the reference set.
03
A living, SPIRIT-aligned draft
Sections are drafted in a live editor with inline clarifying questions, while SPIRIT and ICH-GCP alignment, endpoint logic and statistical coherence are checked continuously — not at the end.
04
An agent team, human governance
Specialist agents — design, endpoints, safety, statistics, regulatory — work in parallel. Every section routes to a named reviewer; every change is versioned and auditable.

What value does each seat get?

For CROs
Win smarter. Deliver predictably.
Up to 95%
shorter protocol-to-eCRF design cycle — the specialist reading week disappears
88%
improvement in data quality through continuous automated validation
45%
less manual workload, so the same team absorbs more studies
25%
profitability improvement from throughput rather than headcount cuts
For Sponsors
Protect assets. Oversee without micromanaging.
20–40%
fewer protocol amendments — inconsistencies surface while the protocol is still editable
Page-level
traceability: every extracted value points back to its source line, for you and for the inspector
Zero
AI outputs that move forward without a named human approving them
Continuous
audit readiness — the justification is written at the moment of the decision
Partnership models

How can you engage?

JUMPSTART
1 WEEK
One real protocol through Parse, View and Forms — run beside your current process so you can compare the output to your own team's.
Zero initial cost
SCALE
8–12 WEEKS
Roll out to a full functional unit and standardize delivery across your feasibility teams.
Functional-unit rollout
GROW
6 MONTHS
Enterprise partnership for scalable delivery, governance, and co-developed capability.
Enterprise partnership

Every engagement includes an ROI timeline showing how faster startups and protected margins pay for the platform.

How can you evaluate it?

15 MIN
Live demo
Watch us digitize a real protocol in real time, with your questions answered as we go.
Start →
5 MIN
Self-guided tour
Explore the Sponsor Oversight dashboard at your own pace — no call required.
Start →
8–12 WEEKS
Structured pilot
Run Proto AI on an upcoming protocol and see risk quantification on your own data.
Start →
✓ HIPAA✓ GDPR✓ FDA 21 CFR Part 11✓ ISO 27001✓ SOC 2 Type II