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Life Sciences

Is Risk-Based Monitoring Rigorous Enough?



In RBM, not all sites are monitored the same way and not all source data is 100% verified. This can make it seem like the monitoring that IS happening isn’t as rigorous or in-depth as it should be…with “should” being the operative word. 

What monitoring “should” look like is based on our past experience and preconceived ideas. What we’re used to is all sites and all source data being treated equally, and anything less than that seems like cutting corners. But things that are new and different aren’t always what they seem.

In an RBM strategy, the monitoring that’s performed 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, when we set aside our existing ideas about monitoring and source data verification (SDV), and genuinely consider the facts, we can see the true beauty of RBM: It’s rigorous precisely where and when it needs to be.

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Marin Richeson

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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