Clinical Supply Optimization: Process Improvement Accelerates Clinical Trial Deliverables And Execution

Today, biopharmaceutical sponsors are under intense pressure to reduce the time required for drug development. As a result, these sponsors are continually searching for new approaches to reduce lead-time and costs without affecting the quality of the clinical trial deliverables and execution.

The Challenge

As one example, a global top 10 biopharmaceutical sponsor reached out to Thermo Fisher with a clear requirement: Reduce the study startup phase to 91 days. In other words, comparator sourcing and blinding, kitting, packaging, labelling and distribution to the sites had to be executed within this short window.

Typically for this type and size of trial, the study start-up phase from took about five months (from the time the sponsor requested the drug to the release of the medication at the depot). The Thermo Fisher Scientific operations team embraced the ambitious goal of reducing timelines by 40% to achieve an optimized supply chain of just three months.