Centralized or On-Site Monitoring – Which is a Better Approach for Risk Based Monitoring?

In the nascent stage of Risk Based Monitoring, it started on-site. But, with the passage of time, the focus shifted towards centralized monitoring. Centralized monitoring for clinical trials is a preferred approach in the present day scenario. With centralization, the benefits of standardization, an organized approach and better control automatically flow in. During the trial delivery, it helps to deliver a result with utmost accuracy and there is no compromise with the patient safety and data quality. On the other hand, on-site monitoring is totally based on source data verification.

The on-site monitoring method has always been complex and there is higher probability of inaccurate results. Above all, it is costly too. With the cost and the complexity of the clinical trials growing in the recent years and the cost multiplying, most of the clinical trials are unsuccessful due to lack of resources.

But with the advent of risk-based monitoring, most of the clinical trials have started to gain consciousness. The centralized approach results in effective monitoring and also ensures that the cost reduces. The regulatory agencies like US Food and Drug Administration (FDA) too prefer the centralized way of monitoring since it has proved to be more successful for clinical researches.

Here we list the benefits of centralized risk-based monitoring:

• It results in fewer errors during the trial. On-site monitoring is limited in scope and more prone to errors. But centralized risk-based monitoring makes use of automated reviews to reduce errors.
• It confirms better analysis as all the data flows in the centralized dashboard where the CRAs can have side-by-side statistical and graphical checks.
• These dashboards are also able to identify the issues and resolve them even when the trial is ongoing, which the on-site monitoring fails to do.
• Centralized form of RBM allows cross-site comparison and helps to recognize the fraudulent data at a faster pace unlike on-site monitoring.
• Central monitoring of KRIs can be effectively done.
• Better speed and quality is also ensured with centralized RBM.

With a smart and simple approach, centralized RBM approach indeed paves the way for better success of clinical trials with cost reduction and improves the quality of clinical trials too.

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