Locations: EU and Norway
Challenge: Clinical trial involving 300 participants across EU and non-EU countries
Solution: Complete logistics management using industry-leading supply chain solutions
In recent years demands for increasingly complex, international and expensive clinical trials have led drug developers to collaborate with specialist couriers to manage their clinical trials supply chain.
Often acting as a third party, the courier manages all the study samples, including liaising with the collection/delivery sites, providing validated packaging, storage and shipment of samples and designing contingency plans throughout.
The customer is a global pharmaceutical company which specialises in the research, development and manufacturing of medicines and vaccines.
For this particular clinical trial Biocair acted as the third party contracted shipping organisation, responsible for the collection, processing, storage, transportation and delivery of human donor samples.
As an expert in clinical trial logistics, Biocair’s staff, across its network of global offices, are trained to understand the essential temperature and time sensitive requirements that are unique to clinical trials.
With over 300 participants spread across five collection clinics in the EU and Norway, and a varied range of samples, including DNA and plasma, there was a need for a secure and seamless delivery throughout the clinical trial.
Furthermore, Biocair drivers were collecting up to eight sets of samples at the same collection site, many having different temperature requirements including dry ice and controlled ambient.
Customs regulations and the need for cost minimisation
As this clinical trial included both EU and non-EU countries, as well as a wide range of samples at each collection site, Biocair had to ensure that all regulatory paperwork for customs was documented prior to shipping. In addition, Biocair created contingency plans at each phase of transportation, including replacement packaging and secondary flight plans in case of any delays with airlines.
As this EU and non-EU multi-site study included remote locations, Biocair’s worldwide network had to ensure the seamless flow of shipments and information, whilst utilising the most efficient transport lanes.
Gary Rivers, Operations Support Manager at Biocair Inc, comments that “As part of our preparation for this clinical trial, we created Standard Operating Procedures tailored to the trial’s requirements and informed each office of the paperwork and packaging requirements.
By ensuring all the preparation was complete, collection and delivery was made in the shortest possible time as factors such as customs clearance were processed and prepared for prior to the arrival of the samples at the airports.”
Personalised logistics for cold chain
Biohazardous materials require special handling, often under cryogenic or ambient conditions, and typically must be delivered within 48 hours. Biocair created a bespoke clinical supply chain for this particular application, establishing a chain of identity and several contingency plans within the plan. Biocair drivers arrived at the collection site with the validated packaging and placed the samples in the boxes, often directly in-front of the customer, thereby ensuring correct handover of valuable materials.
Biocair fully optimised the clinical trial supply chain and ensured all samples were transferred to and from the collection/delivery sites via the most efficient routes. When complications arose, local Biocair experts were immediately available to help expedite the import process, all while maintaining the highest levels of compliance standards in the industry.
A personal approach to clinical logistics
Speaking about Biocair’s expertise and support for this clinical trial, a spokesperson on behalf of the customer stated that “The Biocair office I work with has provided terrific service. The staff are helpful and always responsive to my questions and requests. This trial involved multiple international sites both inside and outside the EU, as well as shipping multiple sample types that had to be sorted at the clinical sites. The shipments were carried out quickly and without any issues.”
Biocair handles and transports investigational medicinal product and samples during all phases of clinical trials, whether they be infectious or non-infectious, ambient or refrigerated or on dry ice.
Wherever possible, Biocair will complete all necessary paperwork, including consignment notes, air waybills, customs declarations, dangerous goods certificates and all labelling for transport.