Case Study

Process And Communication: Navigating Logistical Complexity In Matched Cellular Therapy Trials

clinical trial patient iStock-659270722

Situation:

  • Autologous and other matched cellular therapies hold tremendous promise for oncology and other indications, yet the development of these transformational personalized investigational products can be operationally and logistically complex
  • They may require collecting a range of samples from each patient, shipping those samples to a manufacturing facility for analysis and as raw material for investigational product manufacturing, creating a patient-specific product, and then shipping that product back to the investigative site for administration
  • An issue during any of these 4 steps creates a ripple effect that can impact outcomes not only for the individual patient, but for the entire study. Sponsors count on Precision to avoid such issues.
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