RUNNING SMARTER TRIALS WITH DATA-DRIVEN MONITORING
Clinical monitoring remains one of the most important and most costly activities in the clinical research paradigm. Monitoring provides the operational transparency required by investigators, sponsors, and regulators to make informed decisions about site performance, patient safety, and overall study progress. Yet unlike many clinical trial activities, which have been steadily transformed by technology, the monitoring function itself has changed little.
Now, after several years of industry discussion and recent industry collaboration1, there’s solidifying consensus that adoption of data-driven monitoring can substantially improve study quality, safety, and also reduce monitoring costs, which today account for 15-30% of total study costs. Data-driven monitoring represents a major departure from traditional monitoring in which clinical research associates (CRA) typically visit sites on a fixed schedule. Instead, data-driven monitoring leverages eClinical technology (EDC, CTMS, RTSM) to turn monitoring into a flexible, responsive, team-based activity.
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