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Welcome.

I hope you find some useful nuggets in my posts.  "Start here" is a table of contents and a great place to start.  Otherwise you can click, tap, scroll and search to your heart's content!​

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​Please note that I will be adding new content as mentioned in "Coming Soon" posts for each section.

Risk-Based Quality Management

RBQM extends the concept of Quality by Design into the ongoing study management. The study monitoring, ongoing safety review, ongoing data review and study success tracking is based on important metrics and data analytics. This methodology reflects the study's key risks, trends and important signals whether related to safety, efficacy or integrity.

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