Download: Centralized Statistical Surveillance – Risk Based Monitoring

Under Surveillance
In a sign of the times, the drive for ever-more targeted and effective trial monitoring is leading to the growing take-up of central statistical surveillance to identify unexpected data patterns.On-site monitoring is a resource-intensive component of clinical trials, contributing to over 30 percent of their costs. Moreover, it is estimated that only about 50 percent of the monitor’s time is actually spent on monitoring activities, while the rest is spent on travel, logistics and reporting.As a result – and in view of the low R&D productivity and major cost pressures on the pharma industry over the past decade – it is hardly surprising that there has been an increased focus on reducing the cost of clinical trial monitoring by making the process more efficient.Centralized, remote, risk-based and adaptive monitoring are effective strategies which reduce the need for on-site monitoring visits and source data verification (SDV). Indeed, both the US Food and Drug Administration (FDA) and the European Medicines Agency are urging greater reliance on centralized monitoring practices to identify when on-site monitoring is truly required, and how it can be optimized using metrics collected by centralized monitoring methods.

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