One thing is certain when supporting a clinical trial - change is inevitable and delays will happen. Whether itâs the manufacturing of drug or packaging materials, procurement of a comparator drug product, or the review and approval process of label text â 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. |