Thought Leadership – PROMETRIKA CRO

Showing posts by Andrew Park, Pharm D.

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August 31 2022 Andrew Park, Pharm D.

Risk-based Monitoring and the Monitor's Roles - Part 1

“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives. We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”
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November 22 2021 Andrew Park, Pharm D.

Source Document Verification and Source Data Review: What's the Difference and Why We Should Care

The thinking on monitoring of clinical studies has been changing over the past several years, so now is a good time to reassess the place of SDV and SDR in the operation of clinical trials.
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