AccuraTrials
From protocol to clean clinical data — without a programmer. The AI reads your protocol, drafts your forms, writes your edit checks, watches every data point, and audits every trail entry.From protocol to clean clinical data — without a programmer. AI builds, validates, monitors, and audits your trial.
Execution failures cost millions.
AccuraTrials catches them early.
The Issue
Traditional systems detect deviations after the risk has occurred. They rely on static edit checks that miss cross-visit inconsistencies and contextual errors.
The Cost
A single FDA Form 483 observation costs an average minimum of $300,000 to remediate, and severe multi-system citations can exceed $1.5M in direct operations and consultant costs.
Our Solution: AI Copilot
Operates right inside the eCRF. It understands protocol context during data entry, proactively catching errors and data-quality gaps before they become inspection findings.
Turn millions of passive audit logs into
active risk defense.
The Issue
It is humanly impossible for monitors to manually sort through 5.9 million data points to verify data integrity and catch late safety reporting. When risk is buried in complex logs, oversight fails.
The Cost
Inadequate site monitoring is a top driver of sponsor Form 483s. 25% of FDA sponsor inspections result in citations, triggering costly remediation, delayed submissions, and compromised data reliability.
Our Solution: Audit Trail AI
Our AI auditor acts as an automated, continuous monitor. It scans millions of logs for risk signals: missing change reasons, repeated late edits, and site-level anomalies — surfacing issues before they become inspection findings.
AI suggests your edit checks.
- Describe a rule in plain English — AI proposes the logic for your approval
- Quick Add builder: field → operator → value in 3 clicks
- 4 outcomes: Block Save, Auto-Query, Warning, Conditional Required
- Live SVG branching diagram updates as you configure
Four AI systems. One compliant study.
Build — Feed it your protocol
Upload a protocol PDF. The AI reads it and drafts your eCRFs, visit schedules, and branching logic. You refine and approve.
Validate — Describe rules in English
Say what you need: "Age must be 18+." The AI writes the edit check — field, operator, value, outcome. Review and apply.
Monitor — AI watches every entry
While your study runs, the AI screens for missing data, out-of-window visits, protocol deviations, and anomalies — flagging them for your team.
Audit — AI reviews trail activity
Millions of audit entries, scanned continuously. The AI surfaces unusual changes, late edits, and inspection-readiness gaps before an inspector does.
What AccuraTrials is purpose-built for
AI-native from day one. Not retrofitted onto legacy architecture.
See it live in 30 minutes.
Personal demo — we'll walk through your exact study type and answer every technical question.