Supporting a Small Biotech to Deliver a Critical Phase III Clinical Trial in Canada

The client, with a lean clinical operations team of just 12 people, was facing several key challenges:

• Limited attention and prioritisation from larger vendors
• Complex handling requirements for temperature-sensitive vaccines
• The need for specialized labelling, storage, and Importer of Record (IoR) services
• Pressure to meet highly competitive enrolment timelines for a pivotal Phase III trial

The Challenge

This US-headquartered biotech, with operations in Canada, was preparing for a Phase III clinical trial critical to its commercial success. However, as a smaller organisation, they had consistently struggled to receive the level of attention and service quality expected from larger suppliers.

Despite the high standards required for Phase III studies, the client found that many large vendors deprioritised smaller sponsors, impacting responsiveness, flexibility, and overall execution. Recognising the importance of getting this trial right, they made a strategic decision to partner with a specialist provider better aligned to their size and needs.

Internally, the company chose to focus its resources on core competencies across study design, clinical science, and trial execution, while outsourcing key operational components such as packaging, distribution, and logistics.

Through a trusted referral, our Canadian team was selected to support the study. The client required not just operational execution, but a partner capable of acting as an extension of their team—providing proactive guidance and rapid responsiveness.

Our Solution

We approached this partnership with a clear objective: to deliver the same level of attention, quality, and responsiveness that we provide to all our global clients regardless of size.

From study start-up, we worked closely with the sponsor to design a flexible, end-to-end logistics strategy tailored to their specific requirements. This included:

• Temperature-controlled logistics: Managing frozen storage and handling of sensitive vaccine products with strict adherence to protocol requirements
• Specialist courier selection: Leading the identification and qualification of a logistics partner capable of maintaining product integrity throughout transit
• Labelling and storage services: Providing fully compliant labelling, as well as refrigerated and frozen storage solutions
• Importer of Record (IoR) services: Assuming legal responsibility for shipments, ensuring all regulatory documentation was accurate and complete

Given the regulatory complexity, we ensured full compliance with both Health Canada and U.S. FDA requirements, including the management of necessary documentation such as No Objection Letters and import permits.

To support the client’s competitive enrolment targets, we implemented a proactive, demand driven scheduling approach, ensuring sites received product exactly when needed, without delays or shortages.

Throughout the study, we maintained a high-touch communication model, including weekly calls during start-up and regular distribution updates, ensuring full transparency and eliminating uncertainty around product status.

The Outcome

Our tailored, proactive approach enabled the successful execution of a highly complex clinical trial:

• 103 shipments delivered across two protocols within 12 months
• Zero temperature excursions, ensuring full product usability upon arrival
• No delays or holds due to regulatory or documentation issues
• On-time support of competitive patient enrolment rates

The client particularly valued the responsiveness and accessibility of our team, noting that challenges were quickly identified and resolved, with clear corrective actions implemented.

As the study progresses toward closeout, timelines remain on track, and the partnership continues to strengthen.

Conclusion

This project demonstrated the value of a collaborative, high-touch approach to clinical trial logistics. By combining specialist expertise, proactive communication, and a commitment to treating every client as a priority, we enabled this small biotech to successfully deliver a critical Phase III trial.

The relationship established through this study is now extending into future programmes, reflecting the trust built and the consistent quality delivered.

Oximio’s Clinical Trial Supply Chain Solutions in Canada

If you are planning your next clinical trial in Canada or North America, take a moment to discover our comprehensive range of supply chain solutions across the region, or contact us to find out how we can support your research. We’d be happy to help.