Quality Assurance
FDA Update on ICH E6, E8, QbD and RBM in Clinical Trials
Posted in: News & Articles, Quality Assurance
Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) approaches in clinical […]
Read More....Revolutionizing Clinical Trials: The Power And Potential Of Risk-Based Monitoring
The article explores the benefits and misconceptions of risk-based monitoring (RBM) in […]
Read More....The Fallacy of the Corporate Memory Concept
Posted in: Quality Assurance
The article challenges the concept of “corporate memory” within large CROs, arguing […]
Read More....Shifting the Approach: 4 Strategies for ICH E6(R3) Implementation
Posted in: Quality Assurance
Successfully navigating the evolution of Good Clinical Practice requires well-defined implementation Strategies […]
Read More....Gap Analysis and Collaboration Lead to Success
Posted in: Quality Assurance, TMF
Gap analysis, when properly executed and coupled with true collaboration, is a […]
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