Tag: protocol deviation risk

Link Between Performance and Regulatory Compliance

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Link Between Performance and Regulatory Compliance Understanding the Connection Between Site Performance and Regulatory Compliance Introduction: Why Site Performance Is a Regulatory Risk Indicator When a clinical trial site fails to meet operational expectations—such as subject enrollment, protocol adherence, or data quality—it often foreshadows deeper issues in Good Clinical Practice (GCP) compliance. Regulators like the…

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Historical Performance Review, Study Feasibility and Site Selection

Supply Chain Contingency Planning for Rare Disease Studies

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Supply Chain Contingency Planning for Rare Disease Studies Ensuring Supply Chain Continuity in Rare Disease Clinical Trials The Importance of Contingency Planning in Rare Disease Supply Chains Supply chain disruptions in clinical trials can jeopardize not only timelines but also patient safety—particularly in rare disease studies where patient populations are small and geographically dispersed. Unlike…

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Operational Challenges, Rare and Orphan Disease Trials