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A Clinical Supply Chain is described as the chain from raw materials right through to worldwide distribution to customers. The clinical trial supply includes the 24-hour collection and delivery of biological specimens, investigational drugs, kits, and other study materials and supplies, expertise, and assistance. As the pressure to get drugs to market faster increases, Supply Chain Management (SCM) is a key aspect of achieving these efficiencies. Generally, the requirements of clinical trial materials are created by trial design, so the supply chain planning should start with the development, review, and optimization of a comprehensive trial protocol and then be finalized. Furthermore, the early involvement of supply chain experts can rapidly analyze necessary drivers connected with supply chain complexity.
Clinical trial supply chain management is a process of designing, planning, executing, and monitoring supply chain activities in a timely and cost-effective manner. It is an increasingly complex task in clinical trials planning and management. The structure of supply chains varies depending on the medical type, geographical position, the development of players, and other factors. Robust supply chain management is critical to the uninterrupted supply and quality assurance of clinical trial products. The biggest challenge for a clinical supply chain is the inability to meet the demand for trial drugs, which can result in interruptions of clinical trials. Before clinical trials begin, it is difficult to predict exactly how many drugs will be needed. The risk of supply chain disruptions can be reduced by regularly monitoring inventory levels and constantly re-forecasting trial demand based on the latest recruitment data.
Supply chain management has five basic components, including planning, sourcing, making, delivering, and return. Planning is essential to control inventory and manufacturing processes, which helps in the balance of supply and aggregate demand. Sourcing is the vendors that can provide goods and services in the most economical and efficient way. The vendors should meet certain standards to ensure the quality of goods. On the other hand, the delivery time is also a key aspect for identifying vendors. The third component is to perform all activities related to the transformation of raw material to the final product, such as assembling, testing, and packing. Another most important component of supply chain management is the delivery of finished goods and services. They must be delivered through the company's distribution channels and logistics services. Returns are the post-shipment customer support process associated with various returned products. Similarly, the low quality, defective, expired, or excessive raw materials can also be returned to the suppliers/vendors.
Fig.1 Basic Components of Supply Chain Management (Creative Biolabs)
It is difficult to achieve timely trial delivery with balanced cost, because of the constant battle between service, time, cost, and flexibility. The manufacturers must balance the relationship of the four factors and carefully assess the delivery time. For instance, according to the number of products, the initial supply can be transported by air and the replenished supplies can be routed by ground transport. Another example is that a single standardized process can be used to order high-volume, low-priced products with a long shelf life, which eliminates frequent reordering. The clinical trial supply is a business with volatility, uncertainty, complexity, and ambiguity. Manufacturers must consider both quantitative and qualitative parameters to develop and implement optimal logistics strategies, and balance the four dimensions of services, time, cost, and flexibility.
Fig.2 Align supply chain strategy (Creative Biolabs)
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