The Evolution Of Risk Management In Clinical Trials

When the concept of risk based monitoring was first introduced, following draft guidance from the FDA, the industry implemented it primarily as a cost saving measure to reduce source data verification and to decrease monitors‘ travel time and time on site. Over the past five years, that emphasis has shifted from risk based monitoring of data to risk management of all factors that could jeopardize a trial at each clinical site. The concept of addressing trial risk holistically has also been aided by the relatively recent introduction of cloud-based clinical trials. The cloud has made anywhere/anytime, centralized monitoring (adaptive-on-site and off-site) of all risk-related trial factors a seamless reality.

Looking ahead, the cloud can integrate centralized monitoring, risk management measures, and predictive analytics. It can also create risk repositories, to keep trial costs in check and optimize better quality results for life saving therapies.