June 2, 2025
Import Strategy
Importing Investigational Products: Getting It Right the First Time (Without Burning Time or Budget)
Importing clinical trial materials sounds simple—until it isn’t. The paperwork doesn’t line up. A comparator gets flagged. A country requires a license you didn’t know existed. Suddenly, your first-patient-in date is at risk because a shipment is stuck at the border.
Here’s the reality: importing investigational products (IP) is not an afterthought. It’s a strategic function that, if neglected, can quietly jeopardize your entire trial.
Start With This: Imports Aren’t Just Logistics
Most teams treat imports as a shipping task. But they’re actually a regulatory, operational, and legal risk zone.
Jurisdictional classifications vary. That placebo or investigational device you’re sending might be classified as a pharmaceutical product in another country. That affects not only clearance, but potential taxes and licenses.
Someone has to be the Importer of Record (IOR). And no—it’s not always your depot. If you haven’t confirmed who holds that responsibility country by country, expect delays.
Documentation must be precise. Invoices, Certificates of Analysis, import licenses, trial protocols—all need to align and match the declared value and classification. If even one document is inconsistent, you risk delays, holds, or rejections.
Where Imports Go Wrong
Clinical teams often assume their depot provider is handling the entire import process. The reality? Most providers execute what you’ve told them. They might not escalate country-specific red flags unless you’ve asked them to—or worse, they might not recognize the risk until it’s too late.
You need cross-functional alignment between supply chain, regulatory, and clinical operations to define the strategy. This means identifying required documents, assigning responsibility for customs filings, and understanding each country's import regulations before a shipment ever leaves the warehouse.
A Few Moves That Make All the Difference
Successful sponsors plan proactively. Some techniques worth building into your playbook:
Pre-approve import documentation with local regulators. Especially helpful in the EU, LATAM, and APAC—this avoids friction at customs.
Tailor invoices to the destination country. One invoice template won’t work everywhere. In-country Customs agencies expect certain line items, formats, declarations, and statements—especially when controlled substances or dual-use items are involved.
Clarify duties and tax liability. Will your local depot pay? Will your CRO pass it through? If this isn’t clear upfront, you’re likely to see last-minute cost disputes and site onboarding delays.
Import Delays = Trial Risk
Here’s what this really comes down to: every day your shipment is delayed, your timeline suffers. Site activations stall. Patients can’t dose. Study milestones slip.
And in most cases, it’s not due to bad luck—it’s due to preventable oversight.
That’s why import strategy deserves to be embedded early, during study design. It’s not just about clearing customs. It’s about clearing the path for your trial to stay on track.
Final Takeaways
Align early on documentation, IOR, and country-specific requirements.
Involve regulatory and clinical teams—not just supply chain.
Don’t rely on your depot or 3PL to catch strategic risks.
Localize your invoice and shipping templates.
Track the impact of delays—not just shipments.
You don’t have to be a logistics expert to get this right. You just need to ask the right questions, get the right people aligned, and build imports into your trial risk planning from day one.