Life Sciences

Does Risk-Based Monitoring Increase Trial Risk?

risk-based-monitoring-in-clinical-trials

 

Life Sciences - How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process

This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.

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Just hearing the word “risk” can make people feel anxious, so it’s natural that the term “risk-based monitoring” conjures up concern. But, in reality, RBM is actually about mitigating risk in clinical trials. 

In an RBM strategy, rather than treating all sites and source data equally, the monitoring that’s performed (on-site and remote) is focused on the sites that need the most help and the data that’s most critical to the study or most likely to be recorded wrong.

So, you see, by focusing the resources you have on the areas that need the most support, you actually reduce the overall risk of your clinical trials.

About the Author

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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