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. |