How Robust Is Your Analytics Engine?

Unlock the Power of Lean, Trusted Insights in Clinical Research

Free 20-Minute Teaching on

June 18th at 12pm EDT

Is your analytics engine built on expert-driven custom work — or is it automated, adaptable, and always ready?

Every manual step adds cost, delay, and risk — especially under ICH E6(R3), which assumes your analysis is planned and reproducible.

Data teams shouldn’t have to choose between compliance and efficiency. With FLEX, you get both—automated workflows, better quality, and less manual effort. Meet regulatory needs while saving time. Smarter, faster, easier.

person staring at screen of ones and zeros

Is Your Audit Trail Just a Log — Or a Powerful Risk Management Tool?

Audit Trail Analytics – From Records to Real Insights

person staring at screen of ones and zeros
quality control
quality control

Are You Ready for ICH E6(R3)? Build a Smarter Approach to Risk-Based Monitoring.

Risk-Based Quality Management (RBQM) Implementation

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Building Pharma Solutions? Are They Scalable, Practical, and Built to Last?

Solution Consulting & Implementation

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Nechama Katan
Nechama Katan

Want to Elevate the Conversation? Book a Speaker Who Brings Insight and Impact.

Speaking Engagements & Training

Want to solve the impossible and turn chaos into clarity?

The Wizard's Library

Essential Knowledge for Clinical Trials & Risk-Based Thinking

  • ICH E6(R3) – Good Clinical Practice Guideline (2025)


    The latest GCP guideline from ICH, E6(R3) emphasizes risk-based quality management, audit trail analytics, and proportionate approaches to trial oversight. A must-read for understanding evolving regulatory expectations in modern clinical trials.

  • Wicked Problems (CogNexus)

    Wicked problems are complex, shifting challenges with no single solution, no clear endpoint, and no definitive test of success. Each attempt to solve them changes the problem itself. This classic paper lays the foundation for understanding wicked problems—and why they require collaborative, adaptive, and systems-based approaches rather than linear thinking.

  • ICH E8(R1) – General Considerations for Clinical Studies (2021)

    This updated guideline reframes quality in clinical trials by promoting a culture of trust, open dialogue, and critical thinking. It moves away from rigid, checklist-driven approaches, advocating instead for risk-proportionate planning and engagement of stakeholders, including patients. A foundational read for anyone designing studies with integrity, relevance, and operational excellence in mind.