Preparation Key for Global Trade Compliance in Clinical Trials

Matthew Leets of Alkermes discusses navigating customs, taxes, and shipping for investigational products across borders

Apr. 13, 2026 at 11:06am

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A minimalist studio still-life photograph featuring a stack of customs forms, a shipping label, and a small glass vial on a clean, monochromatic background, symbolizing the abstract corporate strategy and logistics challenges of global clinical trial compliance.Navigating the complexities of global trade compliance is crucial for pharmaceutical companies conducting international clinical trials.Boston Today

For global clinical studies, shipping investigational materials and active pharmaceutical ingredients (API) to sites in different countries from a central manufacturing base can be complex, with each country having different procedures for taxes, customs, and import permits. Matthew Leets, head of global trade compliance at Alkermes, emphasizes the importance of early preparation to address these challenges, including properly valuing unpriced investigational products and managing blinded shipments.

Why it matters

Navigating the 'Holy Trinity' of customs valuation, customs description, and country of origin is crucial for pharmaceutical companies conducting global clinical trials. Improper handling of these elements can lead to delays, extra costs, and even unblinding of studies. As geopolitical tensions and new trade policies impact supply chains, having trade compliance expertise involved early is key to avoiding disruptions.

The details

Leets explains that for investigational products without a commercial market price, companies must calculate a value based on the cost of inputs like API and manufacturing. For placebo-controlled studies, the placebo is typically valued the same as the active drug minus the API cost. To keep blinded studies compliant, companies may 'blind' the entire customs invoice by elevating all line items to the highest value, though this incurs extra taxes. Leets also notes that recent geopolitical events like the Iran conflict and US pharma tariffs are likely to impact transportation costs, but should not directly disrupt clinical trial shipments unless the routes cross conflict zones.

  • Leets will present on this topic at the upcoming Arena International Clinical Trial Supply (CTS) New England conference on April 14, 2026.

The players

Matthew Leets

Head of global trade compliance at Alkermes, a pharmaceutical company.

Alkermes

A pharmaceutical company that develops and manufactures investigational drug products.

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What they’re saying

“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.”

— Matthew Leets, Head of global trade compliance

“Often, companies may 'blind' the entire customs invoice. The partially compliant solution I have landed on in the past is to elevate the value of all line items in the invoice to the highest value. But the downside is having to pay extra VAT and taxes. Still, it's the best compliant solution to keeping an invoice blinded.”

— Matthew Leets, Head of global trade compliance

What’s next

Leets will be presenting on this topic at the upcoming Arena International Clinical Trial Supply (CTS) New England conference on April 14, 2026.

The takeaway

Proper preparation and involving trade compliance experts early in the process are crucial for pharmaceutical companies to navigate the complexities of global clinical trial logistics, from customs valuation and documentation to managing blinded shipments and adapting to changing trade policies.