5 Benefits of Risk-Based Monitoring (RBM) Within Clinical Trials

On May 3, 2018

Risk-Based Monitoring is a procedure which ensures the quality of a clinical trials study by identifying, monitoring and mitigating the risks that could affect the safety of a study. RBM leaves behind the traditional approach of monitoring clinical trials that involves visiting the laboratories frequently. Instead, RBM promotes a centralized approach to data collection as well as monitoring.

RBM mainly targets high-risk areas scientifically in addition to operationally and influences technology and other resources to mitigate these risks.

Why is RBM on the rise?

In recent years the cost and complexity of clinical trials have increased intensely. A third of studies can now be recognised to the traditional on-site review of trial data.

Efficient monitoring is an important process which looks at protecting the well-being of patients and maintaining the reliability of the final results.

According to regulatory bodies including the FDA, RBM is now the favoured method for monitoring clinical trials.

5 benefits of Resource-Based Monitoring

1) Real-time data entry: RBM encourages real-time data entry. Research studies found that sites which deploy RBM are 5 times more likely to enter study data within 7 days.

2) Time Efficiency: Employees have more time to focus on their core accountabilities due to their administrative tasks being reduced considerably.

3) Better Compliance: Data-driven insights and other digital tools help facilitate early detection of problems, improved training and identification of potentially fraudulent activities. These factors automatically result in better compliance.

4) Lower Cost: Over a quarter of the cost of a clinical trial is tied up within monitoring activities. As a result of this, if we can enhance the monitoring, we can reduce the costs.

5) Low Error Rate: By comparing the traditional studies, RBM’s process has reduced the number of critical data errors by as much as four times.

To learn more about the benefits of RBM, attend Arena International’s tailored RBM session at this year’s Clinical Operations in Oncology Trials East Coast 2018. Register today and Quote MK-BPS to reserve your place.