Under Surveillance

International Clinical Trials
November 2013
By Chitra Lele and Samyuktha Ajay, Sciformix

On-site monitoring is a resource-intensive component of clinical trials, contributing to over 30 per cent of their costs. Moreover, it is estimated that only about 50 per cent 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).

Read the full article on Risk Based Monitoring and Centralized Statistical Surveillance.