AIT ensures timely deliveries across North America for ground-breaking eyesight-restoring clinical trials

Published on: Aug 27, 2024

AIT ensures timely deliveries for eyesight-restoring clinical trials

Summary

When a biotech company focusing on regenerative therapies was set to launch a clinical trial to restore eyesight for patients located across North America, they turned to the experts from AIT Worldwide Logistics’ Critical Solutions Group for an innovative and efficient logistics model to ensure the timely and secure delivery of their crucial shipments.

 

CHALLENGE: International logistics, temperature- and time-sensitive materials 

The client needed to ship allogeneic cells from a manufacturing facility in Memphis, Tennessee, to 23 medical locations across the United States and Canada for immediate transplants to patients. These shipments were crucial for a Phase 1 clinical trial aimed at restoring eyesight. 

Not only did the materials need to be kept between 2° and 8°C for the duration of transit, but there was a strict requirement that they also had to be delivered within 48 hours. The client wanted to include patients in Canada as part of the clinical trial, but a regulatory consultant declared that it would be impossible to make deliveries within the required timeframe.

Additionally, the client faced the challenge of navigating Canadian customs regulations, which required a streamlined process to avoid delays and reduce risk.

 

SOLUTION: Comprehensive, rapid shipping with continuous oversight 

AIT stepped in to provide an end-to-end logistics solution that overhauled – and significantly improved – the client's existing model. Our approach involved delivering pre-labeled shipments from the manufacturing facility to Memphis International Airport, booking overnight air freight to locations across the U.S., and lastly, hot shot transportation to each of the final destinations, including some providing transborder services from the U.S. to Canada.
  • Arranging hot shot transport from the manufacturing facility to the Memphis airport
  • Utilizing air services on AIT's existing account with a longstanding partner, allowing the team to maintain close control over the shipment
  • Coordinating final mile deliveries using hot shot vehicles to ensure timely arrivals

To address the customs challenges in Canada, shipments destined for metropolitan areas like Toronto and Vancouver were flown to nearby U.S. airports, where hot shot vehicles were used to complete the border crossing. Entering Canada via ground rather than air meant the Pre-Arrival Review System (PARS) could be utilized, simplifying entry into the country and drastically reducing wait time. AIT also guided the client through becoming a non-resident importer, simplifying the customs clearance process and further minimizing delays.


 

“Thank you for all your work shipping our cells. We faced some serious obstacles, and [the AIT team] really saved us time and again. It is because of your excellent work we finished on time! Thank you for everything!” 
- Biotech company Phase 1 trial project manager


The AIT Difference Makers

Several key factors made the customer’s experience with AIT extraordinary:

Expertise and Innovation
By leveraging extensive logistics expertise, AIT’s professionals transformed the client's supply chain model, enhancing efficiency and control over the shipment process.

24/7 Support
AIT's Critical Solutions Group provided proactive communication including ongoing support and guidance, particularly in navigating complex customs regulations.

Reliability and Speed
Our solution ensured consistent 14-hour door-to-door transit times, an improvement compared to the previous delivery model, which was crucial for maintaining the integrity of the clinical trial materials.

Customer Empowerment
By helping the client become a non-resident importer with Canada, we empowered them with greater control and reduced the risks associated with cross-border shipments.



RESULT: Critical logistics solutions for groundbreaking medical therapies

AIT successfully delivered allogeneic cells to various destinations across the United States and Canada well within the strict 48-hour window. In fact, the Critical Solutions Group’s creative solution enabled transborder shipments to Canada that were delivered in just 14 hours. Our innovative logistics model not only met but exceeded the client's expectations, demonstrating that what was deemed impossible by a consultant was indeed achievable with AIT's ingenuity and expertise. 

This project's success has led to ongoing work with the client, with plans to continue using this process as they move towards production in early 2025.

Additional Resources