ICH E6 R3 | Cyntegrity

Nov 2024

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

Blog, News

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

By Linda Bunschoten - Chief Marketing Officer|2024-11-20T18:27:43+02:00November 19, 2024|Blog, 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.

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

By Linda Bunschoten - Chief Marketing Officer|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.

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

By Julien Nunes Goncalves|2024-09-17T16:35:45+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).