protocol

Dec 2024

Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy

By |2025-01-17T12:35:24+02:00December 31, 2024|Good Clinical Practice, News|Comments Off on Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy

The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management. Combined with RBQM principles, sponsors can streamline trials, enhance safety, and align with regulations.

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.

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