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Management of cold chain clinical supplies presents sponsor companies with significant logistical challenges, especially considering the global nature of distribution to many less developed regions and emerging markets. When investigational products are shipped, supplies are subject to various factors which may influence the way in which temperature-controlled shipping systems may operate. These variables include a myriad of external temperature ranges, supply routes, transit time, and availability of stability data and people.
The nature of clinical trial shipments means that they are exposed to more risks than commercial shipments due to their urgency, diverse destinations, shipping methodologies or routes and variable shipment quantities. However, the goal still remains to ensure a consistent flow of material arriving at the site in a condition which is fit for its intended use.
When contemplating cold chain logistics, there are a number of elements to take into consideration:
- Packaging for maintenance of temperature control – active and passive shipping systems
- Use of monitoring devices
- Courier selection and transit time
- Planning for deviations
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