Just-in-Time or Plan Ahead? Mastering Logistics Strategies for Complex Clinical Trials

Logistics for clinical trials must adapt to rapid changes, while delivering products safely, reliably and on time. However, not all clinical trials are equally straightforward. Some – such as decentralized clinical trials (DCTs), global trials, and trials with cell and gene therapies (CGTs) or other short shelf-life products – can add layers of complexity that make them more challenging to coordinate.

Coordination of these complex clinical trials requires a careful balance of advanced planning and in-the-moment capabilities. Some elements of logistics need to be flexible, while others should be preplanned to ensure all needs are met. For clinical trials in which logistics are particularly intricate or supply chain disruptions are expected, it’s essential to distinguish between what requires flexibility and what must be planned in advance.

Storage and transport conditions

There are some things in the conduct of a clinical trial that are nonnegotiable, and high on that list are the environmental requirements for maintaining a drug’s integrity. Any lapses in planning or lack of sufficient equipment puts the therapy, and as a result the trial as a whole, at risk, making it critical to prepare proper storage measures at every step in its journey. 

This is particularly relevant for investigational medical products (IMPs), such as CGTs or certain vaccines, that must be stored and transported at extremely low temperatures – sometimes as low as the cryogenic range – to maintain viability. In these cases, logistics coordinators should be prepared in advance with the proper equipment and procedures to ensure that no temperature excursions take place. Savvy coordinators will have an established temperature-control infrastructure that includes the appropriate storage, shipping containers and packaging, including liquid nitrogen dewars and dry shippers.

Regulatory considerations

Equally inflexible are regulatory requirements. In addition to compliance being a central component of achieving approval, regulations related to logistics often focus on ensuring the safety, stability, and quality of a product, ultimately protecting trial participants and the trial’s integrity. Rigorously planning this element is imperative to safeguarding the compliance of every step of a trial.

A particular concern for logistical coordination, regulations surrounding the import of IMPs can add to the complexity of global clinical trials. Before an IMP is released for use in the European Union (EU), for instance, a qualified person must certify that the batch complies with European good manufacturing standards. Prior to EU import, rigorous records – including necessary supply-chain timelines, temperature-control and storage-condition records, and detailed shipment inventories – must be maintained to ensure compliance with all regulations and sponsor specifications. The import of CGTs, meanwhile, can involve even more stringent regulatory requirements, including detailed shipping and handling instructions, chain of custody, and traceability.

Labeling

Labeling, however, is an area in which sponsors should be prepared for change, making just-in-time labeling a worthwhile consideration. Under just-in-time principles, labeling is performed only shortly before it is needed, rather than well in advance, offering greater flexibility for last-minute changes. Additionally, this can conserve resources by only using the necessary materials, and avoid delays due to the need for relabeling.

Just-in-time labeling can be especially useful in the case of DCTs and other dynamic trial formats because participant enrollment and site assignment can shift unpredictably, and labels must include the most accurate, up-to-date information possible. Applying labels too early carries the risk of participant or site information changes, which would require relabeling, likely at significant cost. As a result, waiting to apply labels to DCT materials until shortly before they are shipped is often the best way to ensure efficiency.

Routing

The best route for transporting materials is extremely malleable. Countless unpredictable factors, such as traffic, weather, and closures, can turn a typically faster route into an unacceptable delay. In some cases, rerouting mid-transit may be necessary, relying on real-time tracking and up-to-date information about factors that can impact travel time to determine the most optimal pathway. This extends to being able to pivot to alternative methods of transportation, such as when mechanical difficulties result in a flight cancellation and require the use of land transport.

While expedient transport is critical for the majority of clinical trials, it is exceptionally so for IMPs that have limited shelf life, or those that depend on stringent temperature control. Large delays in these cases may put the viability of the drug itself at risk, meaning that it is essential to be prepared to alter routes at any time.

Meeting clinical trial needs

Ultimately, knowing when to be flexible and when to plan in advance comes down to understanding which clinical trial elements are liable to change, and which have no room for variation. When clinical trials are particularly complex, having a partner who can navigate these challenges becomes even much more crucial. An experienced logistics partner, such as Yourway, understands these differences and has the agility to adapt, when necessary, while also supporting a trial’s immutable requirements.