Clinical trials often involve numerous cross-border shipments. Combined with the complexities of different international regulatory bodies this can be very time consuming, resulting in further delays for your clinical trial. Understanding the logistics behind shipping is essential when it comes to distributing your clinical trial drug product internationally and on time. Whether your drug is being distributed to the country next door or travelling overseas, it is important to consider the moving parts on both sides of the border. In this article, we break down some common misconceptions surrounding the shipment of drugs cross-border.
- Documentation: Each country has its own set of shipping regulations that need to be adhered to when delivering clinical trial drug products. For example, shipping from Canada to the United States requires additional international documentation and either an IND (investigational new drug) exemption or a unique IND ID number granted by the FDA. Even with all the correct documentation in place, it can still take additional time for the FDA to approve unfamiliar IMPs (investigational medicinal product) at the border. Here at Bay Area Research Logistics, we make sure to allow for extra time should your IMP be held up.
- Storage Conditions: Clinical trial drug storage is always a top concern. If a product’s temperature fluctuates outside of its required storage environment, the drug becomes compromised. This can easily add unforeseen time and resource requirements to the clinical trial and result in drug wastage. It is important to
partnerwith a trusted international courier, like FedEx or World Courier, to ensure that your drug product is travellingin properly regulated storage. As both of these courier services have a large global network and high connectivity, we collaborate with them to ensure that products arrive at their final destination in good condition. Without a trusted courier, your IMP can become compromised due to the changing temperature conditions and hold times that come with shipping clinical trial drug products cross-border.
- Channels of Communication: There are more moving parts than you might think. Behind every clinical trial there is the owner of the product, the sponsor, the manufacturer, the trial’s entire support system, the shipper, border security, delivery personnel…the list goes on. Bay AreaResearch Logistic’s shipping logistics department manages all of the day-to-day liaising in order to keep all of the necessary lines of communication open and functioning. This ensures that the drug product arrives to its final destination safely and on time. Additionally, each clinical trial drug that we handle has a cohesive team from start to finish so that no information is lost in translation.
Bay AreaResearch Logistics is home to a team of highly qualified individuals who will work with you to support your international clinical trial storage, shipping, and distribution processes. Contact a Bay Area Research Logistic representative to begin developing the most time-efficient clinical trial logistics solution specific to the unique needs of your trial – hassle-free.