01
Build
Protocol → eCRFs
Upload a protocol and draft visits, forms, fields, branching logic, and a study data dictionary — ready for human review.
AI-native clinical trial infrastructure
From protocol PDF to a study your team can trust.
AccuraTrials checks the protocol, extracts study intelligence, drafts eCRFs, generates validation rules, and records every AI and human decision.
Human-in-the-loop Immutable audit trail No-code configuration
Protocol checks
Quality, ethics, regulatory, and study completeness
Structured extraction
Rules, safety measures, eCRF variables, visits, endpoints
Auditable by design
AI output and human reasoning stay permanently traceable
BuildValidateMonitorAudit
One connected system
Four AI systems. One accountable workflow.
The automation is fast. The controls remain human. Every output is reviewable, editable, approvable, and auditable.
02
Validate
English → tested rules
Turn protocol language and plain-English instructions into transparent, editable validation logic with a live preview.
03
Monitor
Every data point
Surface anomalies, missing data, visit-window risks, safety conflicts, and protocol deviations before they compound.
04
Audit
AI + human traceability
Record every suggestion, edit, approval, rejection, reason, prior value, and timestamp in an inspection-ready trail.
The workflow
A clean path from protocol to tested study logic.
Review each AI action at the point where it happens. Accept, edit, or decline with a required reason. Nothing silently enters production.
Walk through the live concept01Upload protocol
02Run preliminary checks
03Review extracted intelligence
04Generate and approve eCRFs
05Generate validation rules
06Test with simulated data
07Audit every AI and user action
Transparent extraction
See the evidence behind every generated item.
Hover an extracted rule, safety measure, visit, or eCRF variable and the exact protocol language is highlighted beside it. Your team can verify provenance before approval.
- Source sentence and page reference
- Confidence and extraction category
- Human approval status and reason
Protocol parser
ONC-204 · Section 5.2
Participants must be at least 18 years old at the time of informed consent. Baseline laboratory assessments must occur within 14 days before the first dose. Any Grade 3 or higher adverse event must be reviewed within 24 hours.
Protocol rule98%
Age at consent ≥ 18
Protocol rule98%
Baseline labs: Day −14 to Day 1
Safety rule98%
Grade ≥3 AE review within 24h
Compliance & audit
Automation that can explain itself.
Every AI suggestion, prompt, source reference, user decision, edit, and approval is recorded. Human-in-the-loop review is built into the workflow rather than added later.
21 CFR Part 11
Credential re-authentication, immutable trail, reason-for-change, and signed approvals.
AI audit trail
Prompts, model output, source evidence, confidence, and final human disposition.
ICH GCP traceability
Subject lifecycle, protocol amendment, SDV, and study configuration history.
Human control
No AI suggestion becomes approved study logic without explicit review.
Built to remove setup friction
Less waiting. More clinical judgment.
30 sec
Plain English to an editable validation rule
0
Dedicated programmers required for study configuration
Same day
Protocol amendment updates without a vendor change order
✦
Bring your hardest protocol.See every step.
Trust every decision.
Walk through protocol checks, evidence-linked extraction, eCRF generation, validation rules, and separate AI and user audit trails.