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| home > pmps > spring 2003 > taking the tribulations out of the trials - an examination of the role of the validated cold chain shipper in clinical trials |
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Pharmaceutical Manufacturing and Packing Sourcer
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Everybody who has ever been involved in a clinical trial will be aware of how every stage of the operation, and every component part of the exercise, has to be checked and re-checked with much rigour. This is because the failure of any one part of the exercise can be apocalyptic in its impact. It can bar the route to market, delay approvals, let in the competition and cost millions - both in lost revenues and dipping share prices. In addition there are the human and social dimensions of failing to get a medicinal product to market.
Increasingly more and more of these kinds of product need controlled storage and transit conditions and the most cursory examination of the evidence shows that one of the biggest problems facing anybody running a clinical trial lies in defects in the distribution chain. A significant problem in the commercial distribution of pharmaceutical products, this becomes magnified in a trial situation.
The extent of the problem can be judged from the findings of the WHO: 25 per cent of all vaccines transported by air cargo will not give the protection intended because of defective cold chains. Whilst according to the UK's Medicines Control Agency no less than 35 per cent of all deficiencies recorded by the inspectors auditing pharmaceutical wholesale distributors in the UK related to the control and monitoring of storage transit temperatures.
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