When it comes to getting investigational product to patients—on time and in spec—the Qualified Person (QP) is a non-negotiable asset. Acting as the final gatekeeper before release, the QP holds the line between regulatory compliance and costly disruption.

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.

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.

Transitioning from mid-stage clinical trials to Phase 3—and ultimately to commercial supply—isn’t just a scale-up. It’s a fundamental shift in how demand is defined, how supply is planned, and how risk is managed.

On the surface, the core mechanics of supply planning don’t change. But what feeds that planning does. The inputs on both sides of the equation—demand and supply—look completely different by the time you’re preparing for a product launch. If your planning team doesn’t anticipate that shift early, you may feel it later.