Managing Imports, Exports and Regulatory Hurdles in Global Clinical Trial Logistics
In the world of clinical trials, logistics is more than just the movement of goods — it is the movement of critical, often irreplaceable materials that directly impact human health. From investigational products and biological samples to temperature-sensitive ancillary supplies, getting everything where it needs to be, when it needs to be there, is a logistical ballet of precision and compliance.
As trials become increasingly international in scope, the complexity grows. Navigating import and export processes, meeting diverse regulatory requirements, and ensuring the safe transit of sensitive materials across borders presents a significant challenge.
This article explores how clinical trial professionals can better manage global logistics with the right strategies, technology, and partners — and how Arca BioLogistics is helping organisations overcome these hurdles with sustainability, reliability, and efficiency at the core of our service.
The Complexity of Global Clinical Trial Logistics
Clinical trials today often span continents, involving multiple sites, partners, and regulatory frameworks. While the scientific work is central, behind the scenes, trial success can hinge on logistics:
Will investigational drugs arrive intact and on time?
Can samples from a remote site in Asia be delivered to a central lab in Europe within hours, not days?
Will customs delays cause data loss due to temperature excursions?
To manage these questions effectively, trial sponsors and CROs must have a logistics strategy that integrates compliance, technology, and expert planning.
Understanding Import and Export Barriers
Customs Complexity
Each country has its own rules regarding the movement of biological materials, pharmaceuticals, and investigational products. This includes:
Import permits
Tariff codes
Labelling and documentation requirements
Specific transit licences for controlled substances
Delays caused by incomplete or inaccurate paperwork can jeopardise timelines and sample viability.
Arca BioLogistics mitigates these risks by offering:
Customs pre-clearance support
Expert handling of documentation
Real-time updates via the Arca Live™ portal
Don’t let customs become a bottleneck. Let Arca's regulatory specialists take the pressure off your internal teams.
Regulatory Hurdles: Compliance is Key
In global trials, regulatory compliance is not optional. GxP (Good Practice) principles must be maintained throughout shipping, including:
GDP (Good Distribution Practice) compliance
Chain of custody protocols
Temperature integrity documentation
Audit-ready records
Arca BioLogistics ensures GDP-compliant logistics, providing validated packaging, complete shipment records, and traceability from pick-up to delivery. This means trial sponsors can demonstrate compliance during inspections and audits, reducing operational risk.
Managing Temperature Integrity Across Borders
Biological samples, investigational medicinal products (IMPs), and reagents are often temperature-sensitive. One temperature deviation during transit can invalidate a whole batch.
Our temperature-controlled logistics systems include:
Pre-qualified packaging for all temperature ranges (frozen, refrigerated, ambient)
Reusable loggers for accurate data capture and sustainability
Real-time monitoring through the Arca Live™ portal
Combined, these elements protect trial integrity and reduce wastage.
Speak to us about our sustainable, reusable packaging solutions that meet your compliance needs while supporting your green goals.
Sustainability in a Global Context
As clinical research grows, so does its environmental impact. Sponsors and CROs are under pressure to demonstrate sustainability in trial operations, including logistics.
Arca BioLogistics champions sustainable practices by offering:
Reusable packaging and temperature loggers across all transit conditions
Carbon offset options for every international shipment
Optimised routing to reduce fuel consumption and emissions
Not only do these initiatives reduce environmental harm, but they also align with funding bodies and public expectations around responsible research.
The Value of Reliability in Global Clinical Logistics
A reliable logistics partner ensures that your materials arrive safely, consistently, and on time. In clinical trials, this reliability affects patient safety, data validity, and overall trial timelines.
We provide:
Consistent booking and transit performance
Predictable customs clearance through expert documentation
Transparent pricing and delivery timelines
This consistency allows trial managers to plan effectively and manage their own supply chains with confidence.
With transparency comes peace of mind. Contact Arca today to learn how we deliver predictability in a world full of variables.
Time & Efficiency: Helping Researchers Reclaim Valuable Hours
One of the most underestimated issues in global clinical trial logistics is the time drain on researchers and site staff. Most trial coordinators, lab managers, or clinicians are not logistics professionals, yet they often find themselves managing complex shipping tasks.
Arca BioLogistics addresses this by:
Reducing pre-shipping admin by 84% through intuitive workflows
Offering expert support to manage documentation, permits, and booking
Consolidating processes so users have a single point of contact and visibility through Arca Live™
This allows site teams to focus on patient care, protocol adherence, and data collection — not courier calls and customs paperwork.
Arca Live™: Your Window into Every Shipment
Our proprietary Arca Live™ portal is a game-changer in clinical trial logistics. Designed for transparency, simplicity, and security, it offers:
Live GPS tracking and temperature data
Automated notifications for every milestone
Customised dashboards for multiple stakeholders
No more blind spots. With Arca Live™, sponsors, CROs, and site staff all have real-time access to vital logistics information.
Building Logistics Resilience for the Future
Clinical trials will only continue to grow in scope and complexity. From decentralised trial models to international collaboration, logistics needs to evolve. Resilience, flexibility, and accountability are no longer nice-to-haves — they are essential.
Arca BioLogistics helps research organisations prepare for the future by:
Offering scalable global solutions with localised expertise
Continuously innovating through digital tools and sustainable methods
Collaborating closely with clients to develop logistics strategies that adapt as trials progress
Final Thoughts
Managing global clinical trial logistics is a demanding and high-stakes process. Navigating regulatory hurdles, ensuring compliance, protecting temperature integrity, and improving operational efficiency all require specialist expertise and dependable systems.
With Arca BioLogistics as your logistics partner, you gain more than a delivery service — you gain a strategic ally committed to:
Sustainability through reusable systems and carbon offsets
Reliability with transparent, consistent shipping
Time and efficiency gains that return control to your research teams