AccuraTrials — The intelligence layer for clinical protocols

The intelligence layer for clinical protocols

AI compiles the protocol into structured, executable trial logic. Source-linked, human-approved, audit-ready. No black box.

LIVE IN AN ACTIVE PHASE I TRIAL· STUDY SETUP: 4 WEEKS → UNDER 48 HOURS· 100% SOURCE-LINKED OUTPUTS· ONE GOVERNED MODEL PER TRIAL· AMENDMENTS IN HOURS· REGULATED AI · NO BLACK BOX· LIVE IN AN ACTIVE PHASE I TRIAL· STUDY SETUP: 4 WEEKS → UNDER 48 HOURS· 100% SOURCE-LINKED OUTPUTS· ONE GOVERNED MODEL PER TRIAL· AMENDMENTS IN HOURS· REGULATED AI · NO BLACK BOX·

Stateful protocols. AccuraTrials keeps the trial in sync.

AI reads the protocol PDF and compiles it into a governed, machine-readable model, builds the study from it, and monitors every connected system against it. Follow one protocol through the flow.

CLINICAL STUDY PROTOCOL
PDF
ACT-217 · Phase II
Version 4.0 · Amended
Subjects must be ≥ 18 years of age at screening.
Visit 2 occurs on Day 28 (±3 days).
312 pages
01 · THE PROTOCOL

Every trial starts as a PDF

Hundreds of pages of rules, schedules, and criteria. Today teams read them and re-key them by hand into every system that runs the trial.

312 PAGES · READ BY HAND
02 · INGESTION

Compiled into a machine-readable standard

The document is scanned and every rule is extracted, typed, and validated. Each one stays linked to the exact clause it came from.

SETUP: 4 WEEKS → UNDER 48 HOURS
INGESTION LAYER LIVE
study: ACT-217
rule eligibility.age: >= 18
rule eligibility.egfr: > 45
visit V2.day: 28 · window ±3
endpoint primary: ORR @ 24w
checks: generated ✓
source: linked · p.47
MACHINE-READABLE ✓ · VALIDATED
03 · ACCURA OS

The protocol becomes the operating system

The compiled model is live context for Accura OS. An amendment is a recompile, reviewed by your team rather than re-typed across systems.

AMENDMENTS IN HOURS
ACCURA OS
PROTOCOL-GOVERNED
EDC
CTMS
IRT / RTSM
CENTRAL LABS
ePRO / eCOA
SAFETY / PV
04 · EVERY SYSTEM

Connected to every system, individually

Accura OS holds a live link to each system in the trial. Signals flow in protocol context; issues arrive in red with evidence attached.

DEVIATIONS CAUGHT EARLY

Durable oversight. Every trial runs in context.

The AI does the busywork; your team keeps authority. These are the surfaces for building the study, absorbing amendments, watching data, and clearing queries.

<0h
Study setup
down from 4 weeks of manual build
0%
Source-linked outputs
with a human in the loop at key decisions
0
Systems monitored in context
EDC, CTMS, IRT, labs, ePRO, and safety
PROTOCOL COMPILE PIPELINE · LIVE4 AGENTS · 0 ERRORS
TRIGGER
v5.0 uploaded
source · PDF
STUDY MODEL
Context loaded
rules + history
ORCHESTRATOR
Routing extraction
handoffs active
Schedule agent
Criteria agent
Safety agent
1,847 rules extracted · every one linked to its clause · p.47 §5.2
PAGES READ
312
RULES
1,847
REVIEW
100% human
RUNTIME
accura mesh
Compile pipeline
Specialized agents extract the schedule, criteria, and safety rules into one shared study model, with every handoff logged.
VISIT SCHEDULE · NEXT 7 DAYS4 QUEUED
MONTUEWEDTHUFRISATSUN
Screening S-0142
IN WINDOW
Cycle 1 · Day 15 DOSING
IN WINDOW
Follow-up S-0098
QUEUED
WINDOWS COMPUTED FROM PROTOCOL100% IN WINDOW
Visit windows, computed
Every visit and its allowed window comes off the compiled schedule. Sites see dates; the model checks them.
APPROVAL GATESPART 11 READY
Amendment publish
CRA SIGN-OFF REQUIRED
Edit-check deploy
AUTO · AUDIT LOGGED
Eligibility decisions
HUMANS ONLY
LOCKED
EVERY ACTION ATTRIBUTABLE · EXPORTABLE LOG
Approval gates
AI proposes. Nothing publishes without the sign-offs your team configures.
REVIEW QUEUETODAY
Criteria conflict I-04 vs E-09 · fix draftedREVIEW
V2 window → ±5d · 41 artifacts recompiledAPPROVE
New eGFR edit check from v5.0APPROVED ✓
One review queue
Everything the AI wants to change lands here first, with the diff and its evidence.
DEVIATION MONITORLIVE
Missing visit data · Site 04EVIDENCE →
Lab value out of range · Site 11EVIDENCE →
Dosing outside window · Site 02EVIDENCE →
Deviations flagged with evidence
Every flag carries the protocol clause and the data that tripped it, so nothing is argued from memory.

Figures from our first live deployment. Source-linked outputs are reviewed by a human at key decision points.

Autonomy you can audit. Down to the clause.

The AI does the heavy lifting. Your team keeps sign-off. Every rule it extracts and every change it makes can be traced to its source, checked, and undone.

01 · NO BLACK BOX

The AI shows its work

Nothing it produces is taken on faith.

Every output cites its source
A rule that cannot point to its page and clause does not enter the study.
SOURCE-LINKED
AI proposes. People approve.
Publishing, overrides, and eligibility decisions sit behind your sign-off gates.
SIGN-OFF GATES
Attributable by default
Every read, change, and approval is timestamped and exportable.
PART 11
02 · HARD BOUNDARIES

The platform stays in control

It works within limits your team sets.

Reproducible compiles
The same protocol version compiles to the same model, every time.
DETERMINISTIC
Your data stays yours
No training on your protocols or patient data. PHI stays in your environment.
NO TRAINING
Change-controlled releases
Validation documentation ships with every release, before it touches a study.
VALIDATED
BUILT FOR REGULATED WORK GXP 21 CFR PART 11 HIPAA ALCOA+ AUDIT-READY EXPORTS
06 · THE EVIDENCE LOG

Numbers first. Claims second.

Why the industry was right to keep AI out, and the architecture that makes showing your work the product. Two notes from the founders.

001 · AI in clinical trials · Aug 2026 · 6 min

AI in Clinical Trials: Show Your Work, or Stay Out

Read the post →

The FDA gave its scientists an AI. Seven weeks later it was citing studies that don't exist. Why the skeptics were right, and the evidence-gated process that answers them.

Bhuwan Sai Kosuru · Co-founder & CEO
002 · Engineering · Aug 2026 · 9 min

The Audit Trail Is the Product

Read the post →

Raw model output fails every data-integrity principle clinical trials run on. The checks, the failures that shaped them, and five questions to ask any vendor.

James Gui · Co-founder & CTO

We are making AI safe for clinical trials.

Bring one protocol PDF. Leave with a governed, machine-readable study.

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Request / protocol walkthrough

Bring a protocol. We will model it live.

Thirty minutes on the real platform with the founders who built it. Technical questions are the point of the call.

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