Concept of Centralized Monitoring
Centralized monitoring system is a remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted. Centralized monitoring process can provide many of the capabilities of on-site monitoring as well as additional capabilities. With the advent of electronic data capture tools and clinical analytic technology, it is becoming easier to monitor study data and track the risks or issues centrally or remotely. Even the regulators encourage greater reliance on centralized monitoring practices where appropriate to fulfill responsibilities of monitoring and for effective oversight of a study.
The right understanding and implementation of a centralized monitoring approach is essential in maximizing benefits. The successful implementation of centralized monitoring requires effective planning, process restructuring, cross-functional expertise alignment, and the right technology in place. The studies have shown that traditional ways of conducting frequent monitoring visits, every 4-8 weeks and 100% source data verification do not necessarily result in higher data quality. Therefore, there is a need to develop a smarter and complementary approach to achieve effective study monitoring.
Centralized monitoring if customized and planned properly using right technology offers a smart solution for “oversight” of a trial to ensure compliance to protocol, regulatory requirements. As the cost of clinical trial management is increasing, it is becoming utmost important to have proper oversight of clinical trials/programs to avoid any major setbacks and ensure achievements of expected quality, timelines and budget.
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