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A clinical trial holds many potential risks that could jeopardize a company’s multimillion-dollar drug development investment.
The increasing complexity of clinical trials compounds these challenges. Therefore, comprehensive risk planning, including efficient monitoring and risk mitigation strategy, is essential for efficient drug development under limited contingency resources.
Currently used risk planning techniques may be limited due to the complexity of the clinical trial risk mitigation problem (e.g., multiple risks, multiple mitigation options per risk, risk mitigation impact uncertainty).
Deriving an effective clinical trial risk mitigation strategy could be time-consuming without proper modeling methodology. If a risk eventuates, necessary resources should be available on time to mitigate it.
For efficient risk mitigation plan execution, Quality Tolerance Limits (QTL) and Key Risk Indicators (KRI) should be optimally positioned and aligned with risk assessment, contingency resources, and risk monitoring strategy
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ORBee Consulting offers tools for strategic and operational planning in the biopharmaceutical industry, leveraging operations research techniques for optimization, simulation, statistical analysis, and analytical decision-making.
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