Navigating Complexities In Global Clinical Trial Logistics

By Michael O’Kane, strategic business consultant

As clinical trials expand globally, the logistical challenges surrounding compliance, customs clearance, and temperature-sensitive product movement continue to grow. Sponsors and contract research organizations (CROs) require partners who can offer more than basic shipping services. They need logistics solutions that are integrated, intelligent, and internationally compliant to navigate and handle the “what if” scenarios.

What To Look For In A Specialist Logistics Team

Specialist logistics are especially important for shipments involving:

• investigational medicinal products (IMPs)
• cell and gene therapies (CGTs)
• ancillary clinical trial supplies
• human biospecimens and diagnostic kits.

By hiring or partnering with IoR and EoR specialists, sponsors can achieve compliant, delay-free delivery across all destinations, minimizing risk of disruption.

Before engaging a specialist, look at their leadership team, experience, marketing techniques, and culture. Quite often, some specialist companies may have leaders or marketing teams that portray an image of their company meeting industry quality and sustainability standards. However, always check if they have real GXP and ECOVADIS policies and certification in place, as a sponsor or CRO can be left exposed by teams and companies that fail to meet the required clinical-to-commercial pharma logistics, packaging, storage, and network standards.

In addition, the culture around a company can offer key insights into their commitment to implementing the most successful solutions. Poor culture is reflected when leaders are perceived as the star personnel, whereas the best companies have leaders who shine a light on their operations, customer service, warehouse, and driver teams as the real leaders and the company’s best ambassadors.

Look for the following capabilities:

• next flight out (NFO) services
• door-to-door, door-to-airport, airport-to-airport options
• worldwide GDP compliance
• 24/7/365 availability for hand carry, charter, emergency or critical aid shipments
• multilingual experts at all locations
• full temperature control shipment range: ambient, 2 degrees C to 8 degrees C, 15 degrees C to 25 degrees C, minus 20 degrees C, minus 80 degrees C to minus 196 degrees C
• dangerous goods safety advisers (DGSAs) for DG compliance
• temperature control specialists to design optimal shipping practices
• online tools for booking and live track-and-trace tools
• data loggers for internal and external temperature readings
• fully validated packaging and temperature monitor materials. Advanced systems, such as traffic light system software, can help monitor shipments requiring attention for gel pack or ice replenishment anywhere on route as needed.
• ability to work closely with all major global commercial airlines to ensure seamless flexibility on all routes selected to meet even the most stringent of deadlines.

When choosing a specialist team for complex shipments, look for one that can offer a wide range of packaging solutions across all temperature and non-temperature types and can provide all sizes from small to full pallets in both active and passive modes.

Coordinate Plans With The Logistics Team Up Front

It is essential to begin working with the specialist logistics team prior to the commencement of any study. Best practice would be to have a call with all key stakeholders and make sure they support sending study pack details to participating service partners outlining the following details, along with the local contact in the selected location:

• days of service and transit times
• latest call times (LCT) and latest pickup times (LPT)
• weekend or public holiday contingencies if required
• the nature of the goods (dangerous, not dangerous, UN2814, UN3373, etc.)
• required packaging, temperature parameters, dry ice, or data loggers.

If airway bills (AWBs), specific packaging, data loggers, dry ice, or other specific logistical equipment are required for the study, the logistics team should position these in advance of study commencement at required local offices or with study participants’ addresses as required.

Executing Complex Shipments

When going live, sponsors and CROs should expect a specialist logistics team to manage each step of complex shipments:

• Verify and confirm booking details - Confirm all shipping information, including temperature control settings, shipping origin, destination, weight, dimensions, and special handling instructions, is accurately recorded in a CRM or tracking system accessible to the company.
• Validate temperature control requirements - Ensure all settings for temperature-sensitive shipments are correctly configured in the CRM system.
• Assign carriers and schedule pickup – Select the appropriate airline or courier, coordinate pickup, and ensure vehicles are equipped for the shipment type and temperature requirements.

• Activate tracking and monitoring - Implement real-time tracking of shipments to monitor locations and temperature settings via their tracking systems.
• Communicate with teams and get regular updates - The chosen logistics team must keep key personnel across the organization updated at key milestones at all critical shipment points – such as pickup confirmation, in transit updates, and final delivery confirmation.
• Review shipment performance and assess temperature control compliance - Evaluate shipment performance as per agreed service level agreements (SLAs), master service agreements (MSAs), key performance indicators (KPIs), and documents.
• Proactively manage and fix issues – The best specialist logistics teams are the ones who tackle issues head on, in that they instantly advise on shipping, packaging, storage, distribution challenges or delays, and that the study drug/IMP is being properly managed and monitored. This is the real evidence of a team that cares and has the expertise and skills to solve problems versus ones that will disappear when something goes wrong.

There also needs to be updates and a final overview if and/or where any deviations or issues occur, and the team should take time to go over all items correctly to ensure full success for complex shipments.

The success of clinical trial shipments relies on a specialist logistics team that can anticipate and manage potential challenges, ensuring compliant, timely, and secure delivery.  

Understanding IoR And EoR In Clinical Supply Chains

Clear roles and processes in place – such as the Importer of Record (IoR) and Exporter of Record (EoR) – are essential. Without them, shipments risk delays, detainment, or even rejection at the border. That can mean missed study milestones, regulatory violations, and unnecessary cost.

Specialist logistics teams with experience in clinical trial logistics and cold chain management are no longer optional. They are essential to modern trial success. In today’s tightly regulated clinical trial environment, IoR and EoR are essential for maintaining compliance and ensuring smooth global logistics. These functions ensure that clinical materials are moved across borders legally, efficiently, and with full regulatory transparency.

Without clearly defined IoR/EoR responsibilities, clinical shipments face serious risks:

• Delays due to missing or incorrect documentation
• Fines or penalties from noncompliance with customs laws
• Breakdowns in cold chain management
• Regulatory exposure for the sponsor or logistics provider

CROs and sponsors must understand how specialist logistics teams manage and present IoR and EoR services to ensure shipments move compliantly without disrupting the supply chain. Experienced teams can perform regulatory compliance responsibilities and allow organizations to focus on executing clinical trials.

Final Takeaways

Preparing for a clinical trial, be it preclinical or moving to more advanced phases, requires very detailed planning and thought processes. However, a huge proportion of the preparation work can be made a lot easier when identifying and choosing the right specialist logistics team.

Do your research, verify credentials, challenge over-marketing, and demand proactive transparency. In clinical trials, logistics excellence is not a convenience. It is a safeguard for timelines, compliance, and patients.

About The Author:

Michael O’Kane is a strategic consultant. He is a masters graduate of DCU (Ireland), University of Oviedo (Spain), and University of Limerick (Ireland). He has been working in the biotech, advanced therapy medicinal product, cell and gene, clinical, R&D, and academic cold chain logistics space for over 20 years.