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| home > epc > winter 2002 > rationalised analytical laboratory services for tomorrow's clinical trials |
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European Pharmaceutical Contractor
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For many years now, there has been centralisation of laboratory analysis for particular aspects of clinical trials. The rationale of centralisation to ensure consistent data was realised earlier in the bioanalytical portion of studies than in those related to the safety and efficacy of new pharmaceutical entities. Hence, it is only since the early 1980s that the 'central' laboratory has evolved and its purpose today is much more diverse in terms of service offerings (and client requirements) than it was in the early days.
Recent developments in regulatory requirements and analytical capabilities have brought about a potential for the bioanalytical and central laboratory to form much closer working relationships. Indeed, the rapidly expanding field of pharmacodynamic (PD) biomarkers means that there is an increasing requirement for results from analytical platforms commonly used in the central laboratory to be produced to a standard that will satisfy regulatory authorities such as the FDA - much like pharmacokinetic (PK) data.
This is particularly the case when assay kits are not being used for their intended purpose. Keeping apace of these changes and developments sets a significant challenge for the contract laboratory. Within large contract research organisations (CROs) these analytical disciplines are often under different management structures and may be totally independent of each other from operational and study acquisition standpoints. Here, the challenge is to ensure that the most appropriate method and analytical platform are used. This article will try and provide an insight into the important issues of ensuring that regulatory requirements and quality issues are met, whilst patient, volunteer and animal health welfare considerations are maintained.
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