Your Hub for ICH E6(R3) Guidance & RBQM Insights
As the regulatory landscape evolves, Vertex and its partners must lead with confidence, quality, and clarity. This resource hub brings together thought leadership, implementation strategies, and peer insights—all aligned to the ICH E6(R3) framework and Clue Points’ RBQM Promise.
Whether you’re navigating protocol design, preparing for inspections, or simply staying informed—this page is here to help.
Decoding ICH E6(R3): What It Means for Risk-Based Quality Management (RBQM)
ICH E6(R3) provides greater clarity on proactively designing quality into clinical trials, identifying critical-to-quality (CtQ) issues and adopting risk-proportionate approaches. The industry has been encouraged to implement it in the spirit in which it was written, focusing on issues critical to patient safety and trial success.
So, what should you know about ICH E6(R3), and how does it impact Risk-Based Quality Management (RBQM)?
RBQM Maturity Model Unlocking RBQM Success: Insights, Trends & Strategies for Smarter Clinical Trials
Based on a recent global survey of 119 pharmaceutical and biotechnology companies conducted by Tufts CSDD, the session explores RBQM implementation through the lens of a new maturity model, highlighting traits and challenges across four key groups: Innovators, Early Adopters, Early Majority, and Resisters. Where do you fall on the spectrum? How about your peers? Now’s your chance to find out.
Detecting Data Integrity Risks with ePRO Audit Trail Analysis
This on-demand webinar, hosted by CluePoints, GSK, and Pfizer, explored how two global pharmaceutical leaders tackled this challenge head-on by integrating Time-Based Testing (TBT) into their centralized monitoring strategies.
Whether you work in data management, central monitoring, QA, or clinical operations, this webinar delivered actionable insights into the technologies driving greater confidence in clinical data.
US Executive Roundtable: ICH E6 R (3) Guidelines Key Findings
• Greater FDA Collaboration – The FDA co-led this roundtable, marking a shift toward more open, innovation-friendly dialogue with industry.
• Flexibility Over Rigid Rules – ICH E6(R3) moves away from one-size-fits-all compliance to a principles-based, risk-proportionate approach.
• Clearer Roles, Smarter Oversight – Guidance clarifies responsibilities for sponsors and investigators, and supports modern trial designs and digital tools.
• Adoption Will Vary – Organizations are at different readiness levels—early QA alignment and internal training are essential.
• Training Is Coming – Global training is in development, with more interactive guidance and real-world examples expected soon.
• Built on a foundation of regulatory science and statistical rigor
• Proven to support ICH E6(R3) alignment and inspection readiness
• Enables proactive detection of risk through data-driven analytics
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