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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.

A digital interface showing a person interacting with transparent virtual icons related to compliance, such as "Policies," "Regulations," "Audit," "Guideline," "Requirement," and "Law." The word "COMPLIANCE" is prominently displayed in the center, surrounded by hexagonal icons representing various regulatory and legal concepts.

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.

The Evolution of Clinical Quality: Key Considerations from ICH E6 R3

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of

GxP Best Practices for Safer, Smarter, Faster Clinical Research

GxP guidelines help clinical research meet rigorous standards for safety, quality, and compliance, supporting the development of therapies and medical devices.

Vendor Qualification vs Requalification Audits: What’s the Difference?

Different types of audits can be performed to support your vendor qualification and management program. These audits should be conducted using a risk-based approach. In this blog, we outline the difference between these types of audits and how to identify vendors that have the most potential risk for your program.