Transitioning to risk-based clinical trial management under ICH E6(R3)

Risk-based quality management (RBQM) is becoming central to clinical trial oversight, with ICH E6(R3) emphasising proportional, patient-focused approaches. Sponsors and CROs are moving away from rigid monitoring plans toward strategies that embed quality throughout trial design and execution.

Guide

A Comprehensive Guide to Adaptive Site Monitoring

Blog

ICH E6(R3), Demystified Part 2 | Defining Critical-to-Quality

Ethical and Actionable Trial Outcomes ICH E6(R3) is more than just an update to Good Clinical...

Press Release

CluePoints Appoints New Chief People Officer to Support Next Phase of Global Growth

King of Prussia, PA – January 12, 2026 – CluePoints, provider of leading statistical and AI-driven...

Blog

ICH E6(R3), Demystified: Turning Guidance into Oversight | Part 1

The New Era of Good Clinical Practice: A Practical Guide for Sponsors and CROs The updated...