Temperature-controlled comparator drugs used in clinical trials can be difficult to transport from the manufacturer to the clinical trial site. A trial sponsor must carefully plan and manage the transportation process in order to ensure the drugs stay within their specified temperature range. Any deviations outside this range can compromise, not only the product itself, but the whole clinical trial.
It is crucial, therefore, for a trial sponsor to choose the most suitable type of transportation carrier for its product. This article will provide information on active shipping configurations and their capabilities.
Active shipping configurations rely on either an external electricity source, or on-board battery power, to provide advanced temperature controls. Thermostats are used to sense changes in temperature and activate a cooling or heating mechanism as needed. Some models have built-in cooling or heating systems (sometimes both), whilst others use dry ice as a cooling agent, or phase change materials as a cooling/heating agent.
There are a number of factors that make this type of shipping configuration useful for trial sponsors. These containers are designed to hold multiple pallets, making them ideal for large shipments. Furthermore, a trial sponsor company usually leases a container, if and when needed, meaning it does not take up warehouse space. They are also considered to be safer than passive shipping configurations, as the units lock and remain locked throughout the whole transportation process. This allows for a constant temperature range to be maintained easier, and can also limit any tampering with the product itself.
However, there are also some issues that arise when using this type of shipping configuration. As active shipping configurations are usually leased to the trial sponsor, availability can sometimes be an issue, especially in time-sensitive situations. Furthermore, because they are usually made to support large shipments, it might not be cost effective for a company to use one if it has a small shipment, as it will be paying for empty, unused space. Weather can also be an issue, as cold winter temperatures might affect the functionality of dry ice and batteries etc.
As such, it is clear that there are both positives and negatives involved when using active shipping configurations. Properly understanding the comparator drug temperature requirements, as well as the transportation process, will help a trial sponsor decide whether or not this type of shipping configuration is suitable for the successful transportation of its product.