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Do You Struggle With Complex International Shipments?

Lee Sutton

By: Lee Sutton April 12 2018

Tags: Clinical Supply Optimization, Cold Chain, Logistics for Clinical Trials, Global Distribution, Transportation, Regulatory Import Export

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Managing international shipments can be challenging, especially when it involves emerging therapies that require a cold supply chain. So when faced with that need, wouldn’t it be wonderful if you had one person you could contact who would take care of everything? Unfortunately it isn’t always that easy.

The end-to-end supply chain includes numerous steps, many of which aren’t typically handled by conventional freight forwarders. Questions that must be answered and issues that must be addressed can go beyond basic transportation needs. These include:

    What is the most appropriate packaging solution?
  • Will the Investigator Site be responsible for procuring this, or can it be supplied?
  • Is the selected packaging solution going to be acceptable in both the country of origin and destination?
  • Is there a reusable shipper service, ideally removing shipper when the package is delivered rather than via a follow up appointment?
    Is the material being shipped an emerging/new therapy?
  • Are there defined ‘Harmonized Tariff Codes’?
  • What is the regulatory environment, and does it place additional requirements on the shipper?
    Who will arrange for required international clearances?
  • Who will serve as the Importer of Record (IOR)?
  • Is there a customs broker and, if so, who will be responsible for getting them involved?
  • Who will complete all the required documentation?
  • Who is responsible for which payments e.g. Duty, Taxes
    Who oversees and addresses temperature management?
  • Who provides required temperature data loggers?
  • Who activates, and then who is responsible for deactivating and reporting?
  • If there is a transportation or customs delay, who ensures the materials stay within the required temperature range?

Any one of these issues, if not addressed in advance, may result in delays which can lead to product loss and patient impact. Getting something from Point A to Point B involves a lot more than arranging transportation. As you prepare to initiate trials in new markets, be sure you’ve explored the above areas and have the confidence you need in your supplier(s) that they will help you and your international shipment navigate through the complexities of the end-to-end supply chain.

Join us at the 2018 Global Clinical Supply Chain Conference. Our Technical Workshop “End to End Logistics Management” will explore all these issues in greater detail.

Lee Sutton