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DIA DIRECT: Risk-Based Thinking in Clinical Trials

Risk-based thinking is the key to focusing sponsor resources on the sites that need the most attention. Determining which sites those are and how to best address the risks they present requires advanced digital solutions, including artificial intelligence (AI) and machine learning (ML).


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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

Upon completion of the webinar, participants will be able to:

  • 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

Continuing Education Credits are not available for this event.

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