Export Control Risks Hidden In Clinical Supply Workflows

By Julie David, content lead – Trade Compliance Academy

When clinical supply professionals think about export controls, the first thing that usually comes to mind is shipping investigational product across borders. That’s understandable. Physical shipments are visible, tangible, and often where compliance reviews occur.

But after more than a decade working in export compliance, I’ve found that some of the most significant export control risks aren’t necessarily tied to the movement of product at all. They’re tied to the movement of information.

In today’s clinical supply environment, sponsors are collaborating with CDMOs, laboratories, depots, logistics providers, and clinical sites across the globe. Technical data is shared through cloud platforms. Manufacturing know-how is exchanged during technology transfers. Foreign nationals may participate on project teams, whether they’re located overseas or working within the United States. As studies expand into new countries, activate additional depots, or onboard new service providers, those information exchanges often increase long before the first shipment moves.

As clinical trials become more global and therapies become more complex, many organizations are evaluating automation solutions to improve efficiency and visibility. If export compliance is part of that conversation, and I believe it should be, the question isn’t necessarily which software platform to buy. The better question is what capabilities will help you identify, manage, and document export control risks before they become compliance issues.

Start By Understanding Where Your Risks Actually Are

One mistake I frequently see is organizations evaluating automation solutions before they fully understand where exports are occurring within their operations. If you only look at shipments, you’ll likely miss a significant portion of your export activity.

Think about your clinical supply ecosystem. Where is technical information being shared? Who has access to manufacturing processes? Which external partners can view product specifications, analytical methods, or development data? Are there foreign nationals participating in projects that involve controlled technology? These interactions often occur during routine activities such as onboarding a new depot, transferring analytical methods to a testing laboratory, or preparing to launch a study in an additional country.

Before investing in any automation solution, map both your product flows and your information flows. In many organizations, the latter creates far more compliance challenges.

I’ve seen companies with highly sophisticated shipment tracking capabilities that still manage critical technology transfers through email, shared drives, and manually maintained access lists. That’s a visibility problem, and visibility is ultimately what automation should provide.

For Traditional Small Molecule Programs, Don’t Overlook The Fundamentals

Small molecule studies may not carry the same operational complexity as advanced therapies, but that doesn’t mean export compliance can be treated casually. In fact, some of the most common compliance issues stem from basic process failures.

If I were evaluating automation capabilities for a traditional clinical supply program, I’d focus heavily on classification management, restricted party screening, documentation, and record retention. One question I like to ask is: “Where are your classifications stored?” If the answer involves spreadsheets, individual employees, or digging through old emails, there is probably room for improvement.

Classifications and licensing determinations often remain relevant for years. Teams change. Responsibilities shift. Clinical programs expand into new countries. Automation can help ensure that compliance decisions are documented consistently and remain accessible when they’re needed. This becomes particularly important when a study adds new depots, packaging partners, or distribution regions that require revisiting prior compliance decisions.

The same is true for restricted party screening. Many organizations perform screening when a vendor is onboarded but fail to revisit those reviews as studies evolve. New sites, consultants, logistics providers, and service partners are constantly being added to clinical programs. At the same time, government agencies regularly add entities and individuals to restricted party lists, meaning a screening result that was clear six months ago may no longer be sufficient today. Comparator suppliers, specialty couriers, central laboratories, and regional distribution partners may enter the supply network long after initial study start-up, creating additional screening requirements.

The best automation solutions don’t simply perform screening. They make screening part of an ongoing process rather than a one-time event.

For Biologics, Pay Attention To Technology Transfers

When I think about biologics, I spend less time worrying about the physical movement of product and more time thinking about the movement of information.

Biologics development frequently involves collaboration among sponsors, CDMOs, testing laboratories, and manufacturing partners. Those relationships require sharing proprietary technical information, manufacturing procedures, and analytical methods, and process knowledge. A single technology transfer may involve process documentation moving from a sponsor to a CDMO, analytical methods being shared with a testing laboratory, and manufacturing data being returned to support clinical supply decisions. From an export control perspective, those exchanges deserve just as much attention as a shipment crossing an international border.

If you’re evaluating automation capabilities for biologics programs, I would look closely at how the system manages access to technical information. Can you see who has access to sensitive documents? Can you track when information was shared? Can you demonstrate that appropriate reviews occurred before access was granted? Can you produce an audit trail if someone asks for it two years from now?

Those aren’t always the first questions organizations ask when selecting software, but they’re often the questions compliance teams wish they had asked earlier.

Cell And Gene Therapies Raise The Stakes

Few areas of clinical supply are evolving faster than cell and gene therapy.

These programs often involve highly specialized manufacturing processes, patient-specific materials, multiple external partners, and global supply networks that must operate with extraordinary precision. Patient-specific manufacturing records, chain of identity documentation, and manufacturing slot coordination often move alongside the materials themselves, creating additional information flows that must be managed.

From an export compliance perspective, complexity is usually what drives risk. The more organizations involved, the more handoffs occur. The more handoffs occur, the harder it becomes to maintain visibility.

When evaluating automation capabilities for advanced therapies, I would focus less on individual features and more on whether the solution provides visibility across the broader ecosystem. Can you see who has access to technical information across partner organizations? Can you document compliance reviews before information is shared? Can you track both materials and associated technical data as they move through the supply chain?

I’ve seen organizations maintain excellent visibility over physical product movement while having far less visibility into how technical information moves among partners. In many cases, the latter presents the greater export compliance challenge.

Decentralized Trials Are Changing The Compliance Conversation

Another area that deserves more attention is decentralized and digitally enabled clinical trials.

The industry has embraced remote collaboration, cloud-based platforms, electronic trial management systems, and global access to data. These capabilities offer tremendous operational benefits, but they also create new compliance considerations. Clinical supply teams may be coordinating direct-to-patient shipments, home healthcare visits, local laboratory services, and regional vendors through the same digital ecosystems.

When information can be accessed from virtually anywhere, organizations need to think carefully about who can access it, where that information is being stored, and whether appropriate controls are in place. Server locations and data hosting arrangements can have important export compliance implications, particularly when sensitive technical data is stored, processed, or accessed across multiple jurisdictions. Understanding where data resides and who may have access to it is becoming just as important as understanding where physical products are shipped

This is where automation can be particularly valuable. Access controls, approval workflows, user permissions, audit logs, activity monitoring, and data storage governance may not be the most exciting features during a software demonstration, but they can become extremely important when questions arise about who accessed information, where it was stored, and whether appropriate controls were in place throughout its life cycle.

As organizations modernize clinical operations, export compliance should be included in conversations about system access, data storage, and data governance, not just shipping activities.

Don’t Chase Features. Look For Visibility.

When organizations evaluate automation solutions, it’s easy to get distracted by lengthy features lists.

In my experience, the most valuable automation capability is visibility. That visibility becomes especially important when studies expand into new countries, new partners are added, or technology transfers occur across multiple organizations. Can the system help you identify potential export control risks before they become problems? Can it document the decision your organization makes? Can it provide evidence that appropriate reviews occurred? Can it help you understand where controlled products, technology, and information are moving throughout your clinical supply network? Those capabilities are often more valuable than any individual feature.

At the end of the day, automation should do more than make processes faster. It should help organizations make better decisions and demonstrate compliance with confidence.

As clinical supply chains continue to expand globally and drug modalities become increasingly complex, export compliance will become more intertwined with everyday operations. Organizations that evaluate automation through that lens will be better positioned to manage risk, support global clinical development, and avoid discovering compliance gaps only after a regulatory or auditor starts asking questions.

About The Author:

Julie David is the content lead for the Trade Compliance Academy at Skill Dynamics, where she creates and maintains training programs that help organizations embed trade compliance directly into their business processes. With more than 14 years of experience in U.S. export controls, regulatory compliance, and corporate fraud detection and prevention, Julie brings a strong risk-management lens to building effective compliance programs. Her work focuses on fostering compliance cultures, strengthening internal controls, and equipping teams with the knowledge they need to proactively identify risk, prevent violations, and support business objectives. Through Skill Dynamics’ role-based learning platform, Julie ensures trade compliance training is practical, engaging, and aligned with how businesses actually operate.