As clinical trials become more complex in design, seek to include varying populations and reach patients around the world, having a robust end-to-end supply chain solution is vital to ensure investigational drugs are readily available at clinical sites when needed.
To help build a robust clinical supply chain that supports global trials effectively and efficiently, key areas to consider include:
- Demand Forecasting and Planning
A crucial starting point is to have an understanding of the trial protocol and patient enrolment projections to estimate the demand for the investigational drug. Factors such as trial duration, patient recruitment rates, dosing schedules, and geographical distribution should be considered. In addition, factors related to the study drug such as manufacturing schedule and quantities, dating period and stability program, and kit design should also be considered. Working closely with internal clinical teams and external partners such as contract research organisations (CROs) and your partner contract development and manufacturing organisations (CDMOs) are important for gathering accurate information for demand forecasting.
- Global Sourcing and Procurement
With the major upheaval in supply chains over the past number of years, global sourcing and procurement have been in the spotlight. Disruptions to the pharmaceutical supply chain vary in severity, frequency and lead time – and they happen regularly. Identifying reliable suppliers for raw materials/APIs, packaging materials etc. and working with global CDMOs with a local presence in your clinical trial territories will help secure your supply chain. The criteria for evaluating suppliers should be based on their quality, reliability, regulatory compliance, and ability to scale up to meet global clinical demand and ultimately commercialisation.
- Manufacturing and Packaging
Factor in your clinical supply strategy. Whether you are manufacturing and packing your clinical supplies in-house or partnering with a global integrated CDMO you should ensure your processes have the flexibility to quickly respond to unplanned events that will occur during the trial. Variations from planned enrolment rates or geographies, catastrophic loss of inventory, or interruptions in the supply chain will necessitate creative solutions. Packaging strategies should also be flexible to accommodate issues that arise.
- Distribution and Logistics
Develop a distribution strategy that not only ensures timely and compliant delivery of investigational drugs to trial sites worldwide but maintains the integrity and safety of your drug products throughout the supply chain. Your chosen distribution partners should have expertise in global shipping, customs regulations, and cold chain management if applicable for temperature-sensitive drug products.