Automated Data Flow: The First Step Toward Planned Oversight 

Free 20-Minute Teaching on May 21st at 12pm EDT

Most clinical teams still rely on Excel to manage risk—but manual data won’t cut it anymore. In just 20 minutes, you’ll see why automation is no longer optional, and how better data flow transforms oversight. We’ll challenge your current thinking and show you a simple model for scaling smarter, faster, and stronger.

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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.