Risk-Based Monitoring: Separating the Risk from the Noise

Clinical development professionals are tasked with making sure every trial site runs efficiently, follows protocol and generates the highest quality data. With increasing clinical trial length and cost, Risk-Based Monitoring (RBM) is growing exponentially amongst sponsors and CROs.

In fact, regulatory agencies are now strongly recommending a risk-based approach to monitoring – encouraging sponsors & CROs to focus resources on sites that need the most monitoring. The FDA has issued guidance (Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring) with the stated goal: 

“…to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting… The guidance describes strategies for monitoring activities that reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. For example, the guidance specifically encourages greater use of centralized monitoring methods where appropriate.”

In this video, we share how PerkinElmer Informatics helps companies implement a Risk-Based Monitoring approach to clinical trial development. 

Historically, clinical trial monitoring has always depended on 100% source document verification (SDV) and other on-site monitoring functions to ensure patient safety and data integrity – requiring up to 30% of the $2.6 billion it takes to bring a new drug to market.

This costly practice has been found to have almost no impact on data quality or patient safety – spurning regulatory agencies to encourage solutions such as RBM platforms that integrate data from different trials, at different locations and in different formats. In fact, RBM proponents believe the approach will return an overall reduction in trial clinical costs of up to 20% – making it equally attractive to both sponsors and clinical site managers. 

Watch the video to learn more about clinical trial management and implementing an RBM approach.