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

Abstract

2015 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.