laboratory

Audit Trail Analytics – From Records to Real Insights

With ICH E6(R3) reinforcing audit trail analytics as a regulatory requirement, organizations must move beyond simple record-keeping to actively analyze and leverage audit trail data. As the lead of the Audit Trail Review Analytics (ATRA) Working Group for the eClinical Forum, we bring deep expertise in implementing audit trail analytics—from defining risks and automating data pipelines to selecting, implementing, and integrating audit trail solutions within RBQM workflows. Whether you need a strategy, automation, or a full solution, we help ensure audit trails drive transparency, efficiency, and compliance.

laboratory
microscope
microscope

Risk-Based Quality Management (RBQM) Implementation

Regulatory expectations are evolving—ICH E6(R3) re-emphasizes central monitoring, proportionate risk response, and audit trail analysis in clinical trials. But where do you start? From vendor selection to team setup and study execution, we help you implement RBQM strategies tailored to your trials, ensuring relevance while optimizing operational costs.

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Solution Consulting & Implementation – The FLEX Model Approach

 Building solutions for pharma and biotech that work—and scale—is complex. Using our FLEX Model, we align your solution with business context, integrate it seamlessly with existing platforms, and drive actionable intelligence. Whether you're designing new tools, optimizing existing ones, or implementing innovative solutions for clients, we provide strategic and hands-on support to ensure success.

meeting with sticky notes on a whiteboard
Nechama Katan
Nechama Katan

Speaking Engagements & Training

 From moderating panels to leading podcasts and speaking at conferences, we bring deep industry insights and a dynamic presence to every stage. We also offer RBQM and related training to develop teams into critical problem solvers—teaching critical reasoning, storytelling, and strategic thinking. Explore past engagements or connect with us to level up your team's capabilities. 

Want to solve the impossible and turn chaos into clarity? Let’s talk.