02.22.23 -- Optimizing The Supply Of Decentralized Studies

To help accelerate a product to market, a sponsor can conduct a compressed timeline clinical trial. In order to ensure that the integrity of the study is not compromised there are a number of supply chain considerations to keep in mind, including inventory management and distribution strategy. An integrated solution can help sponsors proactively plan for these studies in advance and avoid potential setbacks.

A biotech company is developing a new class of anti-infective medicine based on minor groove binder compounds. A tablet formulation was a solution, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.

Successfully sourcing commercial products for comparative studies in an effective and efficient manner often proves far more challenging than assumed. A comprehensive plan should include insight from comparator sourcing and clinical supply management.

The need for flexibility in clinical supply has led to an increase in sponsors’ requests for more specialized services, including demand-led supply and direct-to-patient distribution. What are some key supply considerations that sponsors need to keep in mind when planning a decentralized trial? What should they know when choosing a supply partner for these types of studies?