Cut Costs by up to 50% with More Insightful Monitoring
AptivInSite™ – a Smarter Look at Risk-Based Monitoring
Regulatory authorities recently released specific guidance on the acceptability of alternative monitoring approaches, including risk-based monitoring. Applying this framework, AptivInSite enables dynamic management of on-site and centralized monitoring without the need for 100% source document verification (SDV).
Based on an innovative approach to SDV called ‘Verification by Statistical Sampling’, AptivInSite is a robust, effective risk-based monitoring strategy that optimizes trial quality management and is fully aligned with current regulatory guidance. The AptivInSite approach allows sponsors to use resources efficiently, reduce monitoring costs, and ultimately improve the quality of clinical trial data.
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