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Is Risk-Based Monitoring Just A Fad?

by Marin Richeson on February 25th, 2016 | ~ minute read

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While some of you might be hoping that RBM is just a trendy idea that we’ll soon forget, I have to say that when regulatory agencies take the time to draft and produce guidance documents on the topic…

United States Food and Drug Administration (FDA): Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013)
European Medicines Agency (EMA): Reflection Paper on Risk Based Quality Management in Clinical Trials (November 2013)

…it’s most likely here to stay.

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biotech clinical trials compliance CRO medical device pharma RBM remote monitoring Risk-Based Monitoring risk-based monitoring in clinical trials SOPs

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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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