When it comes to preclinical research and clinical trials, the logistics outside the lab are as crucial as the processes and handling of samples inside the lab. In other words, frozen samples must be handled with care and transported in a timely manner to make sure project milestones are reached.

Keep reading to learn about the three capabilities you should look for in a carrier to ensure optimal transportation for your preclinical and clinical samples.

1: Safely transport frozen samples on a global scale

Any frozen samples from which data will be derived for submission to the FDA must be packaged and transported according to Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs). These GxPs apply to samples being transported out of and into the United States.

Partner with a preclinical and clinical trial research firm capable of providing GxP-compliant transportation from the U.S. to other countries. If a firm can arrange and execute the full-service transport of samples from your facilities to its own, you will face fewer logistical hurdles and can focus on other important project details instead. To add further peace of mind, all staff should be trained on all applicable DOT and International Air Transport Association (IATA) regulations.

Specifically, consider a firm that provides secure international shipping via UPS Healthcare. This service uses mesh-sensor location tracking for full visibility into where your samples are in transit. Additionally, UPS Healthcare also comes with a UPS Premier Response Team for rapid crisis response should there be an emergency or logistical problem with your samples.

2: Stay compliant despite layers of regulatory obligations

Depending on the kinds of samples your shipping, where the samples are being shipped from and to, and how those samples are being shipped, you could be subject to any number of logistical regulations.

To avoid any accidental non-compliance, partner with a logistical team fully aware and knowledgeable of the wide array of regulations enforced by government agencies and laws such as:

• Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)
• USDA; Animal and Plant Health Inspection Service (APHIS)
• U.S. Fish and Wildlife
• CDC

The right firm will be able to ensure adherence to any and all applicable regulations while also applying proper Cold Chain logistical practices that ensure your frozen samples are maintained in optimal condition. This firm should also be capable of helping you develop GxP-compliant shipping habits that align with industry standards.

3: Use an in-house courier to maximize transportation security

While third-party carriers such as UPS or FedEx can be reliable, look for a preclinical and clinical trial research partner with its own dedicated, full-time internal courier service. When a firm can offer hands-on transportation between any site in the U.S. and/or Canada, you gain an extra level of security that outside services simply can’t provide.

And because this courier service is part of the research firm, the courier team members will be trained in all applicable DOT regulations and can ensure compliant transportation of frozen samples.

Connect with the StageBio team to learn more about how you can ensure your frozen samples are packaged and transported safely, efficiently, and within regulatory compliance