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| home > epc > winter 2002 > improving clinical trial logistics - a courier's perspective |
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European Pharmaceutical Contractor
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Pharmaceutical companies are entirely dependent on bringing new products to market and valuation of the development pipeline is one of the key influences in determining share prices. Approximately 15 per cent of sales revenue is ploughed back into finding the next generation of products, giving a worldwide R&D budget of US$50 billion. The total R&D investment required to bring a new product to market has been estimated at close to US$800 million, including the cost of failures and interest. All new products need to go through clinical trials and licensing before they can begin earning back the sums invested. Today, clinical trials are carried out on a global level.
Transportation of clinical trials supplies to investigator sites, and patient samples back to central laboratories, are critical elements in the process needing faster and more reliable services. Delays at any stage are expensive and winning even a few days back by efficiently organising and planning clinical trials logistics could potentially be worth millions of dollars. The converse of this argument is equally true. The question is what needs to be done to the current process to yield these benefits.
All stages of a clinical trial involve logistics. Investigator sites need supplies of test drug, test kits and case report forms (CRFs) at the outset of patient recruitment. Once patient samples have been taken, they need to arrive in central laboratories in a defined transit time and in suitable packaging. Insulated packaging and dry ice may be required to ensure that samples remain frozen during transportation. International shipments require documentation (consignment notes, invoices and so on). In addition, dangerous goods shipments (Class 6.2 Infectious Substances) also need to be packaged, documented and labelled in accordance with national and international regulations.
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
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