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One thing is certain when supporting a clinical trial - change is inevitable and delays will happen. Whether it’s the manufacturing of drug or packaging materials, procurement of a comparator drug product, or the review and approval process of label text – any delay puts pressure on the next step in the supply chain. Often the last processes are faced with making up for lost time.

When a global pharmaceutical manufacturer experienced an unexpected six-week regulatory approval delay, they required a flexible solution to ensure first patient visits could proceed as scheduled. The approach involved:

  • Specially designed procedures that leveraged a unique quality agreement
  • Streamlined parallel processes that enabled rapid turnaround
  • Proactive logistics management to expedite distribution


Download this case study to learn how they executed processes in days vs. weeks with zero patient impact.

 
 
 
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