The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber—from packaging, handling, storage & distribution of temperature sensitive Investigational Medicinal Products (IMP), all the way to the investigator site. This eBook provides insight into how we qualify shipping options with a case study example of a ‘return and reuse shipper pilot’ which delivered very positive results.
Establishing best practices for the industry
With over 30 years in this industry and a sole focus on clinical trials, the Fisher Clinical Services team defines best practices to follow when shipping clinical trial supplies all over the world. We work closely with pharmaceutical and biotech Sponsors and regulatory bodies in order to define the best shipping options for a clinical trial protocol.
To that end, we set out to ensure that shipper qualification profiles encompassed ‘real world’ scenarios, based on the huge volume of shipments each profile would support.
In 2015, a project team was established to produce a set of “Global Profiles” representative of Europe/US and international shipping conditions. Ten (10) test profiles were developed (5 profiles for +2˚C to 8˚C and 5 profiles for +15˚C to +25˚C) from temperature and time information on worst-case routes for the company’s Basel, Switzerland; Horsham, UK; Allentown, US; and Singapore locations.
The objective of the project team was to evaluate the performance capabilities of various shippers through rigorous objective testing encompassing a variety of shipping conditions across defined routes.