Transform Clinical Trial Audit Trails into Actionable Intelligence

Why tools, guidance, and training are not enough for ICH E6(R3)

Many Audit Trail Review Analytics (ATRA) implementation efforts focus first on tools and end in friction. This video explores how proportional focus, validated analytics, and seamless operations create flow instead of noise. Confident Fit for Purpose data in clinical trials is not an accident, it is built on context.

How would you assess yourself?

Do you know what your critical processes and data are?

Risks are identified but prioritization remains inconsistent.

Focus is proportionate, risk-based, and clearly defined.

How reproducible and validated are your data flow and analytics engine?

Analyses are manual, unverified, and not reproducible.

Analytics are validated, reproducible, and fully repeatable.

How much friction and manual work do you have in your current process?

Workflows are fragmented and heavily manual in execution.

Tools and processes operate together with seamless flow, no Excel trackers.

Ready to get started?

The Three Requirements for Modern Clinical Trials

Build Proportional Focus

  • Identify which audit trail signals, systems, and processes are most critical to review based on risk. Focusing effort where it matters most aligns with ICH E6 (R3) principles and prevents wasted time on low-value activities. 

Develop Validated Analytics

  • Create reproducible and reliable analytic methods that turn audit trail data into meaningful insights. This enables consistent detection of process anomalies and supports evidence-based oversight across studies.

Enable Seamless Operations

  • Embed audit trail review into data management to reduce friction and speed resolution. Strengthen real-time oversight and inspection readiness per ICH E6(R3).

You need this if -

You're still manually reviewing audit trails

You believe audit trail data is a competitive advantage—not just a regulatory checkbox

Your RBQM program doesn't include audit trail data signals

You’re preparing for ICH E6(R3) inspections and need audit trail readiness

Ready to turn your audit trails into trusted insights that drive better decisions?