ICH E6 R3

Jan 2025

Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know

By |2025-01-16T16:22:21+02:00January 16, 2025|Blog, Good Clinical Practice, News|Comments Off on Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know

The ICH E6(R3) guideline was formally adopted on January 6, 2025, introducing reinforced principles for clinical trial conduct. This final version builds on its draft with clarified expectations and some notable revisions. Let’s explore the highlights and the implications for stakeholders.

Nov 2024

Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease

By |2024-11-25T15:21:25+02:00November 25, 2024|Blog, Good Clinical Practice, News|Comments Off on Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease

Clinical trial participants have the right to access their personal data, a principle emphasized in the ICH E6(R3) guidelines. Sponsors must ensure transparency and provide participants with their data in a clear and accessible format. Our Subject Profiles tool offers a streamlined solution, enabling sponsors to generate comprehensive reports efficiently, thereby meeting regulatory requirements and enhancing participant trust.

Nov 2024

Why Sponsors Should Embed RBQM Principles and Adaptive Monitoring Strategies in Protocol Design

By |2025-01-17T12:39:35+02:00November 19, 2024|Blog, Good Clinical Practice, News|Comments Off on Why Sponsors Should Embed RBQM Principles and Adaptive Monitoring Strategies in Protocol Design

This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.

Oct 2024

Navigating ICH E6(R3): New Standards for Medical Monitoring

By |2024-10-31T10:30:22+02:00October 30, 2024|AI in Clinical Trials, Blog, Good Clinical Practice, News|Comments Off on Navigating ICH E6(R3): New Standards for Medical Monitoring

Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.

Sep 2024

Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

By |2024-11-25T19:43:54+02:00September 11, 2024|Free Infographics, Good Clinical Practice, News|Comments Off on Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

With the ICH E6(R3) guideline set for approval by October 2024, sponsors face new requirements in risk management, RBQM, and data integrity. Stay compliant and efficient by downloading our free infographic that highlights the key differences between ICH E6(R2) and E6(R3).

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