Shipping logistics and distribution is one of the biggest areas of concern facing the clinical trial supply industry today. Companies often rely heavily on external vendors which mean the challenges include not only the process of distribution but also the selection and management of appropriate vendors.
Effectively managing clinical trial logistics involves the specialist management of the entire clinical supply chain, often in a variety of different locations globally. Customs clearance and cold chain management are two examples of the many challenges that arise when addressing clinical trial logistics and shipping.
At a time when pharma companies are trying to save money, shipment costs are a huge expense. Companies are now looking into the cost of air and sea freight as a means of saving money. New strategies for control shipments are currently being explored. One of the challenges associated with shipments are the increasing number of legislations that ensure companies have better control of their materials during transportation. A number of Nordic based companies are exploring risk-based strategies, some of which include looking at the data available on different shipment routes.
The level of risk is assessed on each route, for example, a low risk route may mean the risk of temperature deviation is minimal. In terms of materials, if the IMP is a high risk product, an insulated shipment route would be mandatory. Going forward, it’s best to have an action plan in place in case there are deviations in conditions during transportation. Some companies are finding they have to re-evaluate their entire supply chain and agree on internal risk management if there have been problems with shipment conditions previously, or if the product is labeled high risk.
In this case, a full control strategy may potentially be required. A full control strategy involves insulated shipment containers or controlled refrigeration all the way to the study site. A half control strategy is when there’s a medium risk product involved, which would be transported in storage hubs. The amount of material will also dictate whether a full or half control strategy is used. The risk assessment carried out by the pharma/biotech company will decide this. Most of the time products used for clinical trials are lower risk than products already on the market, suggesting that a full control strategy is always required to transport clinical trial material.
On the other hand, we still need to maintain the correct conditions for the product as it is still being used by patients, as patient risk is clearly paramount. If a warning signal has been received from the control systems, company scientists collect and analyze the data and need to decide what must happen to that particular batch. Clearly this would be a colossal waste of money and time so ideally needs to be avoided at all costs. Hence, it is vital to have systems in place to understand the risk level of products and to monitor their conditions. The solution to avoid any risk at all is clearly to have a full control strategy, but that’s not appropriate when it comes to cost, therefore we need more of a risk based strategy.
Often with clinical trial products, cold shipments are required to keep the material in optimum conditions during transportation. However, again, this form of shipments incurs a high cost. One Nordic company I spoke to explained they generally always use air transport but are currently looking into sea transport and other types of trade, ones which come at a lower price. The main challenge they have with utilizing air transport is cost, but also there are environmental and sustainability issues that come with flying compared to land or sea passage. Transport by sea would encourage companies to save money and become more sustainable, however the down side is the time it takes. The planning side of things would have to be drastically changed if products were to be transported by boat. This in turn could potentially delay the clinical trial and this would have severe impacts on patients if they do not receiving medication on time.
Many companies decide on transporting products for larger studies by sea and products for smaller trials by air. Often companies will not have a container small enough to transport materials for small studies by sea, this is easily done by air. It would pose logistical challenges finding ways to pack a standard size container in order to transport products for a small study by sea. Potential solutions to these air/sea transport challenges could be to encourage companies R&D supply chain to be more flexible. A few Nordic companies have said they are currently working on this now. The clinical supply chain industry could learn more from commercial supply chain as they transport higher volumes of products very successfully and have standard procedures in place. An industry expert said we should talk more to our commercial colleagues and identify what parts we can take and mimic.
A recurring theme within clinical trial logistics is how to address product stability and cold chain management. Often high risk material required for trials is sensitive to radiation or heat. Therefore companies are looking at various methods for temperature monitoring techniques, such as real time monitoring. These techniques are fairly new and allow the clinical trial supply team to receive real time data about the conditions the product is in throughout its whole journey from manufacturing to study site.
Assessing new medicines through clinical trials is gradually becoming more complex due to multiple reasons, such as temperature deviations and changing country specific regulations. The complexity of supply chain logistics will only increase as sponsors begin to look at new sites in new geographies. These challenges are forcing us to have a new view of clinical trial supply chain management. Many companies are exploring different logistical adaptations to help you mitigate risk and reduce supply chain costs.