June 24, 2025
Export Strategy
Exporting Clinical Supplies with Confidence
Getting product out the door isn’t the goal—getting it to site, on time, and without risk is. And when it comes to exporting investigational medicines, success hinges less on logistics and more on foresight.
Clinical exports are often treated like a downstream task. In reality, they’re a risk vector that can derail entire trial timelines if not planned with precision.
Exports ≠ Reverse Imports
It’s tempting to treat exporting as a mirror image of importing. That’s where most sponsors go wrong. Export regulations vary widely by country—and that includes requirements for invoices, HS codes, declaration formats, and even tax-related documents.
One frequent pitfall: mismatched invoice values or missing export documents. These small inconsistencies can trigger customs scrutiny, delay clearance, or result in full shipment holds.
The takeaway? Export documentation should be built with dual compliance in mind—aligned with both the sending and receiving countries from the outset.
Functional Silos Create Gaps
Exports are inherently cross-functional, but most failures happen when roles and responsibilities aren’t clearly defined. Who owns the invoice? Who’s acting as Importer of Record (IOR)? Is the freight provider operating off the latest protocol amendment?
Successful sponsors coordinate between:
• Clinical ops
• Regulatory teams
• QPs and local reps
• Depot managers
• Freight forwarders
A high-performing team will take it a step further—pre-approving invoice templates with both sets of authorities before first shipment. That kind of anticipatory move removes downstream friction when activation windows are tight.
Don’t Miss Dual-Use and Comparator Traps
Export controls ramp up when dealing with rescue meds, comparators, or substances that fall under dual-use restrictions—especially in oncology, CNS, or advanced therapy trials.
Don’t assume clearance is granted just because the product isn’t commercial. Export licenses may still be required, and applying for them late can stall entire supply plans.
The fix? Build export classification assessments into your protocol startup checklist—before depots are even selected.
Five Things to Do Now
1. Treat exports like a regulatory deliverable, not a paperwork formality.
2. Audit your invoice and customs document flow for mismatches before first shipment.
3. Loop in your freight and regulatory partners early—don’t wait for product readiness.
4. Plan for dual-use and comparator licensing even if you think your product is exempt.
5. Standardize SOPs across sites and vendors to prevent version drift and miscommunication.
Clinical trials don’t get delayed at the formulation step—they get delayed at the border. A proactive export strategy protects trial integrity, keeps sites supplied, and ensures patients get what they need—without scrambling after avoidable mistakes.