Risk-based monitoring has been discussed in clinical research for more than a decade, yet many organizations still struggle to implement it in a meaningful and effective way.

In this episode of the Clinical Trial Podcast, we sit down with Dr. Artem Andrianov, a leading expert in clinical data quality and risk-based quality management, to unpack what risk-based monitoring really means in today's regulatory landscape.

Artem has over 25 years of experience in the pharmaceutical industry and is the CEO and cofounder of Cyntegrity a company that specializes in data driven risk management in clinical trials.

Together, they explore how the industry has evolved from traditional monitoring approaches to a more holistic model centered on risk-based quality management and quality by design.

Dr. Andrianov shares practical insights on common misconceptions, why simply reducing monitoring is not a strategy, and how technology and analytics can be used to proactively manage risk.

The conversation also examines the changing role of CRAs, and the growing expectations from regulators and inspectors.

Moses Maimonides (Rambam)

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