When it comes to managing cold chain clinical trial shipments, are all couriers created equal?
No single courier can get into every corner of the world seamlessly. Balancing your risk level with timeline requirements, especially in a cold-chain environment, means understanding which couriers and which types of couriers (integrators vs. premium couriers) you should select for each route and each shipment.
To begin with, let’s review the two major categories of couriers – integrators vs. premium couriers.
- Integrators –These companies typically have fixed and inflexible weekday departure times within a global network. Services can be somewhat limited (e.g. handling dangerous goods), and when shipping internationally, services such as Customs brokerage and proactive management of in-transit shipments (e.g. re-icing when delayed) may not exist. On the positive side, when dealing with small shipments, they are very price competitive.
- Premium Couriers – In contrast to an integrator, these couriers thrive on providing flexible, customized services. When it comes to collecting the outbound shipment they offer daily departures, including weekends, and they work with most commercial airlines. Pickup times can be scheduled according to your needs vs. theirs. From the moment the shipment leaves your door they manage the process to final delivery, often including Customs clearance. Needless to say these services are offered at a higher fee.
Does this mean you should always choose a premium courier for temperature managed shipments? Not necessarily. So how do you balance cost and risk in your courier selection plan?
It helps if you can develop a systematic way to evaluate the options based on actual performance data. Over the years we have distributed a high volume of clinical trial shipments to locations around the globe. As a result of that experience and our data objective monitoring we’ve gained visibility to both cost and performance execution across a range of service providers. Here are a few basic steps that will help you get started:
- Map out your Network. There is a lot that goes into a robust cold chain strategy and the first step is often overlooked. As early as possible in your clinical trial planning process, create your distribution plan and map out the network. Develop a comprehensive list of all your destination countries and number of packaging sites located in each country. Determine each route and how long it will take to get your Investigational Medicinal Product (IMP) from the packaging location to the depot or investigator site in each country.
- Audit the Courier(s). Take the time to examine multiple service providers and be sure to conduct comprehensive courier audits. Make sure that your courier can demonstrate that its internal quality systems, facilities, equipment and infrastructure meet all regulations for handling pharmaceutical goods in the markets you need to serve. Equally important is ensuring you will have door-to-door visibility to your shipment. If a courier does not have an online system for your access, be sure they are pushing status information to you and that you have ready access to a global support team.
- Courier Selection. It may seem easy to just pick one courier to handle everything for you, but that could cause your transportation budget to skyrocket or, even worse, cause unnecessary delays in transit or Customs in the destination country. Be specific about the locations you need to reach, the temperature requirements of your shipment, and the expected service levels you require. You might discover that in some situations an integrator will be perfectly suitable where, in other circumstances, you might require the services of a more specialized courier.
- Confirm Export/Import Requirements. Where international shipments are required, be clear on the roles and responsibilities of all parties. Who will serve as the Importer of Record? Do you know what documentation is required? Do you have a Customs Broker? Never assume a courier will be able to support you with all of these needs.
Learn more about how data-driven decisions on cold-chain supplies management mitigate risk across the clinical trial supply chain.