Risk-Based Thinking in Clinical Trials


This DIA DIRECT Webinar is brought to you by DIA in cooperation with MasterControl.

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In This Webinar...

Risk has always been front and center in clinical trials. Risk-based thinking not so much. The desire to err on the side of caution leads many companies to distribute their risk management efforts evenly across sites instead of focusing those efforts where they are most needed. Instead of taking the same approach across the board, regulators are encouraging pharmaceutical companies to look at where the biggest risks to data quality, patient safety, and trial integrity are, and focus most of their efforts on that.

Learning Objectives:

At the conclusion of this webinar, participants should be able to understand:

  • Effective methods for assessing and mitigating risk
  • Ways AI/ML can expedite risk-based decision-making
  • Tools to help companies complete and analyze their data.


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  Matt Lowe, Chief Product Officer, MasterControl
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Ansalan Stewart, Health Science Policy Analyst, Division of Clinical Trial Quality, Office of Medical Policy, CDER, FDA
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MaryAnne Rizk, Managing Partner, Rizk Management Consulting