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RBQM is now the prevailing approach to clinical trial oversight in regulated drug, biologic, and device development. The core idea is proportionality: monitoring intensity and quality controls are aligned to the risks that matter for subject safety and decision-making endpoints, rather than applying uniform, resource-intensive methods such as blanket 100% source data verification. RBQM centers on identifying Critical-to-Quality (CtQ) factors, establishing Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), and using centralized analytics and targeted on-site activities to address high-priority issues.

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The website promotes a Leadership Assessment as a free tool to help leaders optimize their business and increase success. By taking the assessment, users receive a personalized roadmap. This tool is a starting point for identifying transformational goals, getting clear on what matters most, and building a strategy for sustainable growth with Steven Cooper Coaching.