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European Pharmaceutical Contractor
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Pharmaceutical procurement officers are concerned at the spiralling cost of research logistics (whatever you perceive that to be). It is estimated that 35 per cent of the fixed and variable costs of a central laboratory pertain to the transport and logistic services they provide. Logistics can account for 50 per cent of study budgets, especially for trials involving infectious diseases with anti-infectives. A recent sponsor survey of central labs which solicited quotes from 13 major laboratories showed a substantial per-visit variance of between US$10 and US$60 in logistic charges only. The central lab industry has long recognised that logistics was the weakest link in the central lab concept. Pharmaceutical companies are beginning to realise this statement could be true for them as well.
Business Environment
To describe the pharmaceutical logistic needs, it is necessary to understand the pharmaceutical research status quo. There are extreme pressures facing all pharmaceutical companies. Globalisation and consolidation has influenced buying and outsourcing behaviour. The term 'strategic partnering' is now a must for any large pharmaceutical company. The secure contractual performance and the 'unloading' of certain liabilities are becoming very attractive.
Scarcity of patients in many therapeutic areas is forcing pharmaceutical companies to more distant geographic locations (outreach) where traditional resources are unavailable, giving rise to a dependency on local contractors. Unlike industries such as automotive or computer technology, the term 'production' for pharma translates to thousands of physicians and co-workers, and this is highly fragmented and expensive to manage. Pharmaceutical companies today use a mix of internal and external vendors to execute a global clinical research programme. It is not only central laboratories that are part of this matrix.
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
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