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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