Developing A Strategy To Optimize Clinical Trial Supplies

Given the global nature of today’s clinical trials, effectively managing clinical supplies has become more complex than ever. Efficient supply planning is critical to the overall success and cost structure of clinical research and development (R&D). The annual expenditures for clinical supplies can account for 40 percent or more of a company’s entire R&D budget.1 Therefore, an effective supply chain management strategy is paramount.

The optimal supply management plan is one that strikes a balance between trial demand, trial budget, and available stock. Optimizing the clinical supply strategy will decrease the amount of wasted supplies, drive down costs, and ensure supplies reach the sites on time and in the correct quantities—helping to accelerate time to market.

The purpose of this article is to:

1. Outline the most common factors that influence trial supply and portray the influence they have on the decisions that determine the proper strategy.

2. Demonstrate how changes in the factors alter the plan and why one supply plan will not always translate to the next trial.

3. Briefly discuss what to do once the decisions for the supply strategy have been formulated and some methods of managing the plan during the live trial.

It is important to note that each company has different requirements for which line items are included in a clinical supply budget. For the purpose of this article, all supply and supply-related activates such as manufacturing, procurement, packaging, and shipping will be considered part of the supply budget. Although destruction is typically part of the overall supply budget, it will not be a discussion point.