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For effective clinical trial logistics, it is vital that the right drug is in the right place, on time and within budget. Trials are becoming more global in nature, increasingly complex and involving expensive drug materials that are often in limited supply. Standard models of clinical trial supply - where waste and slow delivery times of material are typical - are not suitable to meet the growing needs of the industry, and new demand-led and hybridised supply models are becoming more appropriate to increase efficiency.
Traditional models, which work with either a supply-led or a just-in-time approach, lack flexibility and efficiency to match trial needs. Demand-led supply, however, takes a dynamic approach to inventory management through the use of bright stock and delayed secondary packaging processing, which is conducted regionally instead of from a central location. This two-stage process sees the primary packaging of the drug being undertaken at a central location before being sent to regional, secondary GMP packaging facilities near the clinical sites involved in studies. Secondary packaging (kit assembly) and the final, patient-specific labelling takes place within these regional packaging hubs, once an order is received from the study sponsor.
Using a demand-led supply model, primary-packaged products can have country-specific labelling added, removing the cost and burden of approvals of multilanguage and multiregulatory booklet labels, so that stock can be sent easily and quickly to whichever site is involved wherever it is located. This flexibility also allows new countries within studies to be added with little delay to logistics.
By using flexible and decentralised stock, overage and wasted materials, which can be as high as 200% when using a supply-led model, can be reduced to below 20%.
Just-in-time labelling, like supply-led demand, is a model based on a static, stock-based approach that uses discrete primary and secondary packaging runs by protocol to produce partially finished, base-labelled patient kits at a central location, which are moved to regional and local warehouses for final labelling, release and distribution. An important difference between just-in-time supply and new demand-led supply models is that the latter produces bright stock, which includes a batch-lot barcode, and undergoes all necessary analysis and quality release immediately after primary packaging. This information is fed into a centralised inventory tracking system that enables the movement of the bright stock to be tracked throughout the supply chain and, importantly, removes the need to test samples of the finished patient kits later, slowing down the release process.
Barcode scanning during secondary packaging at regional GMP-certified facilities verifies that all elements have been assembled correctly in each package and the inventory system is automatically updated. As with the just-in-time approach, patient kits are distributed to the clinical sites based on actual patient need, but with demand-led supply, finished kits receive a single-panel, country-specific label, and the lead time to the clinical site is as short as a few days. The absence of a large, multilanguage booklet label reduces the lead time required for the secondary packaging process, and additional countries can be easily added with a country-specific label.
Clients are looking for shorter timelines, greater efficiency and flexibility, and reduced costs. There is not one model that fits all, and a hybridised model may be the most suitable to ensure the goals and demands of a study are met.
Demand-led supply can be incorporated into nearly all studies, allowing savings to be made in time and money, enabling earlier trial completion and accelerating a new drug's time to market.