Bioanalysis Zone

Development of a generic laboratory manual for biological sample logistics in clinical pharmacokinetic studies

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The European Bioanalysis Forum (EBF) has been organizing ‘Topic Teams’ on issues of importance to the bioanalytical community for several years [1]. Many of these teams focus on internal bioanalytical issues of importance to bioanalysts such as technological innovation, regulatory questions and novel assay validation approaches [2]. However, there is an increasing recognition that we do need to pay more attention to external factors such as interactions and communication regarding clinical, toxicology and project team participation [3]. Topic Team 12, a virtual team of ten EBF member companies and meeting every 2 to 3 weeks by teleconference, focused on topics of interest associated with clinical trial support. Following a member survey and extended team discussion it was felt that the generation of a generic laboratory manual for use in clinical pharmacokinetic studies would offer a potential solution to the common problems created by poor logistical sample management and communication in single and multicentre trials [4]. Such a document would create a single platform to which clinical sites, central laboratories and bioanalytical groups could all relate. The benefits could be significant since a harmonized document should stimulate a consistent way of working and would be a first step in the elimination of many current issues.

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