Risk Based Monitoring (RBM) is a proactive, strategic approach to site monitoring and clinical data management that allocates resources based on need. It goes hand in hand with Quality by Design (QbD), a concept that has been embraced by nearly every industry to help improve processes and create quality products. It’s based on the idea…
Category: RBM
Risk Based Monitoring: A more strategic approach to site monitoring and clinical data management
By Kristie Lively, VP of Clinical Operations & Quality Compliance, eclipse When executed properly, a Risk Based Monitoring approach to clinical trial monitoring helps sponsors allocate resources more effectively, saving money and time and improving data quality. Here’s a closer look at the practice, its future and what it could mean for the industry. The…
3 Key Components to Risk Based Monitoring
Risk Based Monitoring is about using the right people, clear processes and superior tools to run a better trial. Risk Based Monitoring (RBM) is an increasingly popular approach to site monitoring and clinical data management that allocates resources based on risk and need, as opposed to delegating resources equally, regardless of each site’s unique challenges.…
Is Risk Based Monitoring the future of clinical trials?
When and why to opt for Risk Based Monitoring, an increasingly popular approach to clinical trial site management Site monitoring is one of the most costly factors of clinical trials. Traditionally, clinical trial teams have had to allocate equal resources to all study sites, regardless of risk. When adopting a Risk Based Monitoring approach, you…
