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ICH E6(R3) Compliance

How to Prepare for ICH E6(R3) Guideline for Good Clinical Practice

Adoption Timeline

Twenty years ago, the International Council for Harmonisation (ICH) drafted the Guideline for Good Clinical Practice (GCP), ICH E6, an international ethical and scientific quality standard for clinical trials. Since then, the complexity of clinical trials has increased significantly, and ICH E6 has been revised to reflect changes in emerging technology and evolving trial designs.

The latest revision, ICH E6(R3), published in January 2025, builds upon GCP by further emphasizing the importance of proactively fostering quality culture in clinical trials and drug development planning.

 

The European Medicines Agency (EMA) will adopt ICH E6(R3) effective July 23, 2025. Other regulators have yet to announce an official endorsement of these updated GCP guidelines, but the U.S. Food & Drug Administration (FDA) has published a draft guidance. Further regulatory adoption is expected soon, so it’s imperative that investigators prepare to transition from ICH E6(R2) to ICH E6(R3).

Partner with Industry Experts

The experienced team at Trial Interactive can guide you through this change process and consult on advanced technology and services that address the evolving needs of your clinical trial. Our eClinical platform offers ICH E6(R3) compliance through:

  • Inspection-ready eTMF

  • Author-to-archive content management

  • Seamlessly connected QMS & LMS solutions

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Strengthen Your Organization's ICH E6(R3) Compliance

Compliance Essentials

Successfully Support Various Trial Designs

As ICH E6(R3) emphasizes risk-based oversight, data quality, and stakeholder collaboration, it's essential to adopt a clinical trial management system (CTMS) that supports various trial designs efficiently. Trial Interactive’s next-generation CTMS empowers teams to remotely manage activities, streamline study execution, and maintain real-time visibility across the trial lifecycle.

Learn About Our CTMS Solution

Understanding Quality Culture

ICH E6(R3) places heavy emphasis on fostering a culture of quality throughout your clinical trial teams and processes. Learn more about how to achieve this in our free on-demand webinar, The Three Pillars of Quality Management.

Implementation

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Meet with Trial Interactive’s industry experts to learn more about how our clinical products and services support your trial’s compliance with ICH E6(R3) GCP guidelines.

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