10 September 2010
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[ Home > Case Studies > Clinical Trials Phase II - IV > Clinical Trial - 150 collection sites]
Pre - Clinical & Discovery Clinical Trials Phase I Clinical Trials Phase II - IV Finished Products Unique Projects
Clinical Trial - 150 collection sites
Client Large biotech company in the USA.
Route Multiple collections from 150 sites in Europe during a 30 month period. Study involved 2500 patients. Delivery was to a research facility in California.
Commodity Small batches of human plasma samples to be maintained in a deep frozen state. A percentage known to be infected with the hepatitis C virus.
Summary of Services Provided
  • Flexible response to combine & consolidate samples where possible - to save customer's money
  • Reliable and fast shipping methods - to meet customer's security and timeline needs
  • Specialist regulatory knowledge resources at hand - to reduce customer's risk
  • Specialist training documentation provided - to reduce burden on customer's research sites
  • Study logistics designed from clinical needs - to preserve customer's study integrity

Logistics Clinical trials in the later phases often constitute large projects involving many countries and complex logistical solutions. In this particular case samples had to be moved from clinical sites (mostly hospitals) in Western Europe and Scandinavia.

Biocair were informed of collections by the research sites or by study co-ordinators and would then be responsible for providing a comprehensive service for transport of the sample batches, including classification for transport, packaging, dry ice, labelling, documentation and movement from door to door.

Our Solution This project can be achieved using our Special Projects option because it has the ability to design a specific logistical solution to a customers requirements.

The clinical timelines were complex but enabled various ways to reduce unnecessary cost

  • i) by combining collections from several study sites at the same time and
  • ii) by bringing separate sample shipments to a central point for interim freezer storage before on forwarding to the laboratory.

Because of the possibility that only a percentage of the samples generated would be considered to be infectious it was important to produce two sets of responses, one for samples not considered infectious and another for the infectious samples.

At the customers request in the planning stage it was considered whether one response could be designed for both, but dangerous goods regulations are legally binding and failure to observe them can result in punitive fines, so after careful consideration this was ruled out.

Biocair prepared briefing notes for both shipment methods in local languages and working closely with local study monitors, conducted training for the hospital staff to enable them to pack samples in the packaging that was provided.

Biocair prepared documentation for presentation to US customs and US Federal authorities with great care to prevent delay to individual shipments. In this case careful declarations to the US Dept of Agriculture (USDA) and the Center for Disease Control (CDC) were made.

Shipment Overview

After receiving confirmation of the need to despatch samples, Biocair arranged collection, usually between 10:00hrs and 12:00hrs local time. When the collection vehicle arrived with the dry ice the hospital staff used the packaging that had been sent to them previously to complete the packing process.

Consignments were sent using the most reliable air carriers for each individual route and Biocair staff monitored each consignment to ensure that they were transported on time. At the same time we informed US customs clearance staff that the material is on its way. Most consignments were delivered to the analysis laboratory with a transit time of less than 48 hours. All consignments arrived in perfect condition.

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