Opportunities for efficiency in the global clinical supply chain

Over the past decade, clinical trials have become significantly more complex. They now span more regions than ever before, a number of adaptive study designs have been introduced and the participant numbers have fluctuated greatly, with some operating with only a few patients for orphan treatments.

This has placed additional strain on traditional clinical supply chain models to meet such needs while also ensuring greater productivity and efficiency.

What are the traditional models of the clinical supply chain?

Under the traditional clinical trial supply model, the supply chain performs primary and secondary packaging on the bulk drug, adding booklet labels and storing the packages in one or two central locations. When a site requests trial materials, the booklet labelled drugs are shipped.

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However, this centralized inventory may not align with the actual site’s need. Often, a buffer stock of around 200% is included to alleviate any potential uneven demand. Most of this stock will likely go unused.

‘Just-in-time’ labelling is also based on a static stock approach, which uses primary and secondary runs to produce partially finished, base-labelled patient kits. These kits are then held in a central location to await final fixed label updates prior to release and distribution. 

When an order is received, partially finished kits are pulled and given the final pre-printed label. They are then inspected, released and shipped. This is a customization of the traditional model, which offers more flexibility at the point of dispatch, but it can add costs by disrupting the supply process.

What are the benefits of demand-led supply?

To address these shortcomings, many have looked to demand led supply to increase supply chain flexibility, speed and efficiency by uncoupling primary and secondary packaging.

Using a demand led supply model, the primary packaging of the bulk drug is performed in a central location. The drugs are then shipped to regional facilities located closer to the trial sites. This offers a number of benefits.

As the drugs are stored in local sites, the delivery time from a request can be much shorter. Holding decentralized stock that is not committed until a patient need is established can also reduce clinical waste.

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The sites also store the drugs in their primary packaging. Only when a request comes in are they given a relevant country label and patient-specific information prior to shipping. Not only does this increase flexibility of use for the drugs, but it also cuts down the lengthy traditional booklets to an accessible patient and country-specific information.

This flexibility is also useful when it comes to making changes to expiry dates. In a demand-led supply model, you can adapt for late-stage customization. As expiry dates are applied to drugs as they leave the secondary packaging location, you can be sure they feature the most up to date details. This makes a significant change from the traditional task of expiry extension labelling, including re-labelling or destroying stock at clinic sites to meet an expiry date need.

By using bright stocks across the demand led supply model, materials can also be pooled, which can increase efficiency. Pooling stock across multiple studies in regional facilities can mean that when a request comes in from any study, the stock can be labeled as needed.

What are the downsides to demand led supply chains?

The downsides to demand led supply are two fold. Firstly, the system requires an upfront investment of resources and expertise to set up the decentralized GMP packaging centers. The second downside is that all of these centres have to be standardized by standard operating practices across printers, scanners, cameras and ancillary packaging equipment. The systems used across the sites also need to be standardized so they are interoperable.

The clinical trial supply chain can be an important productivity enabler if handled correctly. With companies continuing to seek shorter timelines along with greater efficiency, flexibility and reduced costs, demand led supply could be a viable solution.