GCP - Advarra

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Are you prepared for ICH E6 (R3)?

The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Research organizations must critically evaluate both their clinical priorities and operational procedures to ensure compliance.

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ICH E6(R3) Implementation Starts Now: Are You Ready?

The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.

GxP Audits Guide for Successful Clinical Trials

A robust GxP audit program enhances regulatory compliance by ensuring quality and consistency across investigator sites, vendors, and internal processes in clinical trials.