Expanding Clinical Trials Internationally in the ATMP Space
Expanding an advanced therapy clinical trial beyond your home country is an exciting milestone that reflects not only scientific progress and growing confidence in clinical trial results to date but also represents the potential to reach more patients and positively impact more lives. But for many researchers and early-stage biotech teams, it can also be a daunting step into unfamiliar territory.
Even when the science is ready, operational and regulatory complexities can create barriers. International trials introduce variables like country-specific regulatory requirements, import/export protocols, release procedures such as Qualified Person (QP) release in Europe, and the need for tightly controlled logistics and supply chains. Planning for these challenges early can make all the difference, avoiding delays in favor of decisive progress.
The Reality of Going Global in ATMP Trials
Advanced therapy medicinal products (ATMPs) carry unique sensitivities. They are often time- and temperature-critical, have limited shelf life, and require precise chain of custody from collection through to delivery. Unlike standard pharmaceuticals, these materials can’t sit idle at customs or be replaced if something goes wrong.
At the same time, regulations vary significantly by country. Requirements that seem standard in one region may not translate easily elsewhere. Customs documentation, import licenses, storage conditions, and quality expectations can differ, and a lack of clarity can lead to delays, refusals, or holds.
Planning for international expansion means thinking beyond scientific readiness. It’s about preparing for a new set of operational realities, including navigating different regulatory bodies, aligning documentation formats, and anticipating approval timelines. Many teams find themselves facing a second learning curve just as they’re ready to scale. But with awareness and the right support, this complexity can be tackled with confidence.
Understanding Country-Specific Regulations and QP Release
One of the most misunderstood aspects of international trial expansion is the QP release process in Europe. A QP is a certified individual responsible for ensuring that medicinal products meet regulatory requirements before being released for use.
If you’re shipping investigational ATMPs into the EU without a QP release strategy in place, you risk significant delays. Your shipment may arrive, but it won’t move forward until it’s been formally reviewed and released by a QP. This can impact your timelines, patient access, and even product integrity if serious delays occur.
Imagine planning a dose administration, only to find the product held up due to missing documentation or lack of QP oversight. These aren’t theoretical risks, they’re common pitfalls for early-stage teams unfamiliar with regional regulatory norms.
The good news? QP isn’t a roadblock, it’s just a normal process that can be proactively managed. When you understand documentation needs, approval steps, and timelines in advance, you can integrate QP oversight into your operational plans. Regulatory foresight is more than simple compliance, a robust strategy is active trial risk mitigation.
Navigating Import/Export Challenges and Trade Compliance
Beyond regulatory approval, your trial materials must also move smoothly through global trade systems. Each country has its own import/export requirements, and the simplest of missteps (like incomplete paperwork, incorrect harmonised codes, or a failure to anticipate duties) can derail your shipment.
For ATMPs, which may be classified as biologics, human cells/tissue, or investigational materials, depending on jurisdiction, trade compliance becomes an exercise in operational risk management. And these aren’t challenges that can be solved reactively. Customs delays can compromise product viability, patient schedules, and site readiness.
This is where local insight and expert guidance can make all the difference. Working with a supply chain partner like Cryoport Systems that has a global footprint and understands regulatory and trade nuances in various countries helps you navigate complexity with confidence. Trade compliance should be embedded in your trial planning, not treated as an afterthought.
Coordinating Global Logistics: More Than Just Shipping
When planning global logistics for ATMP trials, shipping is just the starting point. What’s needed is a full-scope, end-to-end cold chain strategy that accounts for chain of custody, lane validation, temperature assurance, continuous monitoring, and contingency planning.
Time- and temperature-sensitive materials like ATMPs must be supported by infrastructure that can match their critical needs. This includes specialised packaging qualified for international transit with appropriate hold times, pre-validated shipping lanes, localised handling capabilities, and the ability to respond in real time if something changes during transit.
What to consider when evaluating a logistics partner:
- Do they offer end-to-end visibility, including temperature and location monitoring?
- Can they demonstrate validated shipping lanes for your countries of interest?
- Are their packaging systems validated and requalified on a regular basis, pre-approved and compliant across all jurisdictions?
- Do they offer integrated support for customs, documentation, and trade requirements?
- Do they provide local coordination and contingency planning in case of delays?
The most effective global supply chains aren’t stitched together, they’re designed with intent. When logistics strategy is integrated with regulatory planning and trial timelines, your study is far more likely to run smoothly as you move to later stages with expanded patient populations and geographic regions.
Actionable Tips for Global Trial Planning
International expansion requires more than just ambition, it demands proactive foresight and the right expertise. While no two ATMP trials are exactly the same, planning for expansion from the earliest stages can help you navigate global requirements with confidence.
Start early. Identify the import/export requirements, regulatory timelines, and documentation needs for each target country during trial design, not after initiation.
Secure a QP release plan. If you’ll be shipping into the European Union, establish a clear strategy for Qualified Person (QP) release, including timelines and documentation responsibilities.
Choose logistics partners wisely. Select partners with integrated capabilities to avoid gaps between shipments and compliance.
Prepare for the unexpected. Build a robust risk mitigation strategy and contingency plans for delays, customs holds, or re-routes, especially for time-sensitive or irreplaceable materials like ATMPs.
Align teams across borders. Ensure your sites, vendors, and internal stakeholders are aligned on responsibilities, communication challenges, and escalation procedures.
Planning for global success doesn’t require over-engineering, it’s about anticipating friction points and smoothing the path before issues arise. With the right structure in place, international expansion becomes a strategic advantage rather than a stumbling block.
Taking your advanced therapy trial global is a significant milestone, one that celebrates scientific maturity and commercial ambition. But success abroad requires more than data and determination. From QP release and regulatory timelines to customs clearance and time-critical logistics, the path to global expansion introduces new layers of complexity that can either be navigated proactively and confidently or become barriers to progress.
The good news is that you don’t have to be an expert in international trade, regulatory affairs, or cross-border logistics, but you do need to plan like one. That means engaging with industry-leading partners like Cryoport Systems early and building a robust framework that accounts for country-specific variables.
Global expansion may be complex, but it’s far from impossible. With proactive planning and the right support in place, you can keep your trial on track and bring transformative therapies to more patients around the world.
