AccuraTrials
Compliance isn't a feature — it's the architecture. Every data change is recorded. Every signature is re-authenticated. Every AI decision is logged. Designed for the day an inspector walks in.Compliance isn't a feature — it's the architecture. Designed for the day an inspector walks in.
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.
Secure by design.
Permanently recorded.
Every EDC has an audit trail. AccuraTrials takes data integrity further. We enforce field-level AES-256 encryption for PHI, generate automated IQ/OQ/PQ validation evidence on every build, and hash-chain our audit logs to guarantee absolute immutability — maintaining audit-ready records at all times.
Request Compliance Docs →Validation Packages & Certifications
We don't just build software; we build validated systems. Our engineering lifecycle is designed to produce inspection-ready documentation automatically.
Automated IQ/OQ/PQ
Every deployment triggers a comprehensive test harness that verifies audit trail integrity, e-signature binding, and access controls. Validation evidence is generated automatically.
SOC 2-Aligned Controls
Our infrastructure and operational processes are designed around the SOC 2 security, availability, and confidentiality trust principles.
ISO 27001-Aligned ISMS
AccuraTrials operates an Information Security Management System (ISMS) aligned with ISO 27001 standards for rigorous risk management and continuous security improvement.
Continuous Code Review
Every line of code is reviewed for security vulnerabilities, performance bottlenecks, and compliance impact before merging. Our architecture is built with compliance in mind.
21 CFR Part 11
FDA electronic records and e-signatures rule. Every feature: credential re-auth on signature, immutable audit trail, automated Part 11 test harness on every build.
ICH E6(R2) GCP
Good Clinical Practice standard for trial design, conduct, and reporting. Full subject traceability, SDV workflow, and protocol-adherent query management built in.
HIPAA
Protected Health Information safeguards. PHI fields are designated at the form level and access is controlled by role and site assignment. Audit trail covers all PHI access.
GDPR
European data subject rights and privacy. Configurable retention policies, data access controls, and a full audit trail of every access event supporting data subject requests.
Inspection-ready from day one.
Request our compliance documentation package, including SOP index and automated test harness details.
Request Compliance Docs →