Audit Detective: Your Frontline Defense Against Compliance Risk
Audit Trails are under the spotlight. Stay ahead of regulatory expectations with Audit Detective — Cytel’s robust solution for audit trail review — to ensure compliance and inspection readiness.
Audit Trails Are No Longer Optional. Neither Is Getting Them Right.
Regulatory agencies now treat audit trail data with the same level of scrutiny as clinical data, and expect proactive, ongoing reviews. Relying on outdated or manual approaches is a risk you can’t afford. Audit Detective is Cytel’s intelligent solution built specifically for this challenge — enabling faster, more reliable audit trail reviews that align with the 2023 global regulatory guidance.
Audit Detective offers a set of standard checks and can be easily expanded and customized to meet your specific study needs. It provides both a graphical view for quick assessment and detailed listings for tracking actions and outcomes. Additionally, users receive audit trail review plan text for easy inclusion in the Data Management Plan (DMP) and structured audit trail analyses aligned with the plan, ensuring a comprehensive and compliant audit trail review process.
Regulatory-Ready
Built to align with global expectations — no gaps, no guesswork.
Scalable & Customizable Solution
Equipped with standard checks and easily customizable to meet study-specific needs.
Data Integrity & Transparency Guaranteed
Identify inconsistencies, unauthorized access, and unusual activity patterns in audit trails through a comprehensive set of checks.
Actionable Outputs
Structured audit trail analyses with detailed assessment reports, providing transparency and ensuring compliance.
Full Visibility Across Critical Systems
Audit Detective goes beyond clinical data to cover the full spectrum your operational environment — delivering comprehensive reviews across systems where compliance lapses can occur:
- Clinical Systems
- EDC
- Biomarkers
- PK
- ePRO/eCOA
Beyond clinical data, Audit Detective is also applicable for audit trail reviews in operational systems:
- Electronic Trial Master File (eTMF)
- Clinical Trial Management System (CTMS)
- Learning Management System (LMS)
Whether you are preparing for inspection or conducting ongoing surveillance, Audit Detective helps you detect risks, prove control, and protect your trial from costly oversight failures.
Claim your free 30-minute strategy session
Book a free, no-obligation strategy session with a Cytel expert to get advice on how to improve your drug's probability of success and plot a clearer route to market.
