Epc june 14 pp 24 27 (psi cro)

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Microbiological Testing

The Central Issue With microbiological testing being a vital component in the laboratory element of any clinical trial, the site for such tests – be it local, regional or central – should be given plenty of consideration in order to ensure quality and suitability Microbiological testing is very important in all clinical trials – it is the organisational structure of the laboratory stage in any trial for a new medicinal product, and can involve the following: O

Tests which require quick medical decisions or routine analyses – usually performed in a local lab

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that is a structural or affiliated subdivision of a clinical centre (study site) Tests with a high level of result unification – for example, assessment of drug safety panel, lab diagnostics, or simple pharmacodynamic studies – or, in cases where the required tests

Andrey Karelin, Maxim Belotserkovsky, Veronika Khokhlova and Olga Sazonova at PSI CRO

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cannot be performed in local labs, specialised central labs are used Tests which are not routinely performed, but are required by the study protocol – for example, pharmacokinetic studies, brand new methods of molecular diagnostics or complex pharmacodynamic studies – and use special labs June 2014


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