Case Study: Clinical Supply Chain & Logistics
Cold‑Chain Storage & Distribution for Global Phase II–III Study
30 Sites. 9 Countries. 4 Depots. 215 Subjects.
The Challenge
A global Phase II–III clinical trial required a highly coordinated clinical trial supply chain to support patients with a rare, high-risk pediatric oncology indication across North America and Europe.
The study required strict cold chain logistics (2–8°C), regulatory-compliant importation, and scalable infrastructure to accommodate potential shelf-life extensions. With 30 clinical sites across 9 countries, the sponsor faced significant complexity in depot strategy, cross-border regulations, and distribution into less commonly supported regions.
Maintaining product integrity, ensuring regulatory compliance in clinical trials, and enabling uninterrupted supply to 215 patients were critical to trial continuity and success.
Our Approach
Tanner Pharma designed a tailored global clinical trial logistics network spanning four depots across the US, Germany, the UK, and Turkey. Acting as Importer of Record (IOR) in each region, Tanner ensured full regulatory compliance and seamless importation.
End-to-end GxP-compliant cold chain logistics (2–8°C) were maintained using specialized courier solutions to mitigate excursion risk. Tanner also implemented compliant returns, reconciliation, and destruction pathways, while enabling a flexible labeling strategy to support potential shelf-life extensions without disrupting supply.
