Clinical trial logistics has become far more complex—especially as decentralized models expand and biologics, cell and gene therapies, and global patient populations place new demands on supply chains. Ensuring the integrity of clinical trial materials, from kit building through sample return, is no longer just an operational concern—it’s central to trial success.

In this Q&A, Jose Ianez, Senior Director of Logistics Operations LATAM at Marken, shares his perspective on the challenges behind today’s clinical trial supply chains. With more than 25 years in healthcare logistics, he oversees operations across Latin America—from planning through final delivery to the patient.

Here, he discusses how Marken’s Laboratory Advantage service is helping sponsors streamline kit supply, protect sample integrity, and improve the speed and reliability of clinical trial logistics.

Contract Pharma: As part of Marken’s Laboratory Advantage, what are the most critical aspects of supplying kits and moving specimen samples, and how does it expedite the processing of clinical trial materials and specimens?

Jose Ianez: At the core, it comes down to three things: speed, sample integrity, and compliance. Everything we do is built around protecting those priorities.

A lot of it comes down to knowing the regulatory environment since the rules can change from country to country, especially in regions like Latin America. Our teams stay in close contact with local health authorities, so we’re usually aware of changes early and can adjust before they cause delays.

Where sponsors tend to run into delays is exactly there—regulatory gaps, incomplete documentation, or packaging that doesn’t meet requirements. Those issues can slow things down quickly. We help bridge that by supporting documentation, preparing shipments correctly from the start, and coordinating across all stakeholders—sites, brokers, CROs—to make sure everything is aligned before a shipment moves

CP: Why is Marken’s Lab Advantage essential to optimization and efficiency in the logistics for today’s clinical trial arena?

Jose: Trials today are more complex, and the materials involved—especially advanced therapies—are more sensitive. That puts a lot of pressure on timelines, particularly when you’re moving samples from patient to lab with very limited windows of time.

We’re constantly looking for ways to reduce transit times. That might mean testing new routes, working with different airports, or even introducing new logistics pathways that haven’t traditionally been used for clinical trials. But it’s not just about speed—it’s about proving those routes work, validating them, and ensuring regulators are aligned.

We also rely heavily on data. We test scenarios, analyze performance, and use that information to guide decisions—what routes to use, where risks exist, and how to mitigate them. The result is more predictable delivery timelines, fewer disruptions, and better overall trial efficiency.

CP: What happens on your end when regulations change—does it affect how you handle shipments?

Jose: It does. Even small changes—like a tweak to paperwork or import rules—can slow things down if you’re not expecting them.

We try to stay ahead of that as much as possible. Our regulatory teams keep a close eye on what’s coming, so we can adjust early—whether that means updating processes, coordinating with partners, or putting backup plans in place.

At the end of the day, experience helps. When you’ve dealt with these situations before, you can react faster and keep things moving without putting the samples at risk.

CP: Could you tell us about the challenges you have experienced managing the logistics for clinical trials, and how Marken has been able to overcome and differentiate from the competition?

Jose: There are always unpredictable challenges—regulatory changes mid-shipment, infrastructure limitations, even labor disruptions. The key is being able to respond quickly and make decisions based on real-time data.

We’ve had situations where regulations changed while shipments were already in transit. In those cases, we were able to pivot quickly, implement alternative solutions, and still maintain cold chain and delivery timelines.

One example that stands out was during a prolonged customs strike in Brazil. Because of the relationships we’ve built with local authorities and our involvement in industry groups, we were still able to move clinical trial materials without impacting patients. That kind of local engagement and regulatory alignment is a big differentiator for us.

CP: Tell us about the technology Marken uses to accelerate shipments and elevate the Laboratory Advantage offering?

Jose: Technology is a big part of what we do. We have 24/7 control towers monitoring shipments globally, with real-time tracking and the ability to respond immediately if something goes off track.

We also use sensors that provide product-level visibility—monitoring both internal and external conditions throughout the journey. That gives sponsors confidence that temperature and handling requirements are being maintained at every step.

On the packaging side, we’ve introduced several solutions designed for both performance and sustainability. For example, our InfiniDI solution extends temperature stability for more than 144 hours without dry ice replenishment, while InDigo uses fully recyclable materials. We also have larger passive systems like the Vault, which can maintain temperature for extended periods—even in locations without reliable infrastructure.

Marken’s Credo Vault passive shipper is designed to maintain temperature stability for high-value clinical materials, even in regions with limited infrastructure.

CP: How does Laboratory Advantage work to expand the geographic reach of trials and increase diversity?

Jose: Latin America is a great example. It offers strong patient diversity and cost advantages, but historically there have been barriers around infrastructure and regulatory timelines.

We’re helping address that by developing new routes, improving logistics capabilities, and working closely with local authorities to streamline processes. At the same time, we’re supporting trial sponsors and sites to ensure materials can move efficiently and patients can stay engaged in studies.

When you combine the right logistics network with proper packaging, regulatory alignment, and technology, you can reach more patients—and that ultimately improves trial diversity and outcomes.

CP: In the future, what changes do you see for supply chains connecting clinical trial materials, patients, and sites?

Jose: We see logistics becoming more integrated into the clinical trial process—not just moving shipments, but supporting sites more directly.

That includes helping with documentation, guiding processes, and even taking on some administrative tasks so sites can focus on patients. As trials become more decentralized and hybrid, logistics providers will play a bigger role in connecting patients, sites, and sponsors.

At the same time, therapies will continue to grow in complexity, and cold chain requirements will become even more demanding. Sponsors should be thinking now about partners who can adapt to that—both in terms of infrastructure and expertise.

CP: For sponsors evaluating partners today, what should they be looking for in a logistics provider to ensure both speed and sample integrity across increasingly complex trials?

Jose: First is compliance—you need a partner that understands the regulatory environment in detail. Second is technology and expertise, especially when dealing with complex clinical trials and sensitive materials.

And third is the ability to take on more responsibility. Sponsors increasingly want logistics providers who can handle regulatory processes, act as importers of record, and manage the operational details so their teams can stay focused on the trial itself.

That’s really where we see our role—acting as an extension of the sponsor’s team, bringing the expertise, infrastructure, and local knowledge needed to keep trials moving efficiently.

Beyond Logistics—A More Integrated Role

Marken’s approach extends beyond transportation. The company works closely with regulatory bodies, customs authorities, and industry groups to help shape processes that support clinical trials.

In regions like Latin America—where government involvement in healthcare systems adds complexity—this level of engagement can help streamline approvals and avoid bottlenecks. The company also supports sites directly in some cases, helping reduce administrative burden so teams can focus on patient enrollment and data collection.

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