Hi,

Clinical trials involving controlled drug products carry a unique set of considerations that add logistical complexity, and it is the responsibility of the sponsor company to guarantee patient safety, regulatory compliance and to ensure there are no interruptions in the supply chain.

For one sponsor, there were several variable factors creating uncertainty in material forecasting of a controlled substance. Weight-based dosing, varying import regulations, and investigational material requiring 100% accountability were key considerations in developing a supply strategy.

Download our latest Case Study to find out how Almac Clinical Services helped one sponsor with inventory management and demand forecasting for a global, pediatric clinical trial involving a controlled substance.

Kind regards,

Almac Clinical Services