The continuous flow of site performance metrics is a key element in the implementation of adaptive monitoring techniques and is essential for remote monitoring. Real-time patient data provides continuous performance metrics giving operational teams clear visibility into how each site is performing, allowing for scheduled site visits based on site performance and study requirements.
Adaptive monitoring combines continuous remote monitoring with need-based site visits to optimize site performance and involves CRA time both in-house and on-site. This replaces the fixed schedules and rigid adherence to predefined plans used in traditional studies, and allows dynamic resource allocation to all monitoring activities.
The challenges associated with monitoring clinical investigations, particularly complex adaptive clinical trials, has prompted the FDA to encourage the adoption of alternative monitoring solutions that will ensure the collection of quality data and the safety of study subjects. The FDA addresses this topic in the draft guidance, “Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring” (August 2011)
With AptivAdvantage™ we develop and manage an appropriate, risk-based monitoring plan for an adaptive trial that customizes the level of source data verification (SDV) and the number of required site visits based on actual study results. This enables sponsors to potentially reduce the number of monitoring visits and study monitors to realize study efficiencies leading to significant cost-savings.