Preparation is key to understanding global trade compliance for trials

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different procedures in place, this can be confusing to navigate for companies that have little to no experience in running global studies.Investigational products do not have a set price since they are not yet available on the market, but a price must be in place for companies to pay the appropriate levies. While managing shipping requirements for participant-blinded studies that require a placebo, which is not taxed in the same way, something as simple as an unblinded shipping label may unblind the trial, significantly affecting operations.Matthew Leets, head of global trade compliance at Alkermes, says that preparation is key in addressing the challenges faced for shipping investigational products. In a conversation with Clinical Trials Arena, Leets outlines the potential solutions for shipping challenges, and touches upon the most recent supply chain questions in light of the US-Israel war with Iran.Matthew Leets, head of global trade compliance at AlkermesLeets will be presenting on this topic at the upcoming Arena International Clinical Trial Supply (CTS) New England conference on 14 April.This interview has been edited for length and clarity.Matthew Leets (ML): The key things are what I call the Holy Trinity - customs valuation, customs description, and the country of origin. For customs purposes, those are the required elements for any transaction. There are additional complexities with clinical trial material that intersect with, say, the Ministry of Health or the US Food and Drug Administration (FDA) or equivalent government agencies and their requirements, like import permits to gain entry into the destination country. Other complications depend on how the recipient countries' jurisdictions are structured, or which entities have concerns about the nature and type of the material.ML: Most of the issues surface due to different compliance requirements, and we are a very marginal use case within the global space. Rules are written principally for global trade, the exchange of goods and services that have a tangible cost attached. 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