The presentation will review the key requirement for compliance for the analysis of samples collected from subjects participating in clinical trials and forms a key part of the clinical trials process. Sample analysis or evaluation provides important data on a range of endpoints which is used, for example, to assess the pharmacokinetic profile of investigational medicinal products and to monitor their safety and efficacy. Consequently, it is essential that sample analysis and evaluation is performed to an acceptable standard which will ensure patient safety is not compromised and that data is reliable and accurately reported.

This presentation will explain the new standards which will be required by laboratories analyzing clinical trial samples. The session is aimed at sponsors using clinical laboratories and those at laboratories who wish to demonstrate to sponsors of clinical trials and government agencies worldwide that the clinical laboratory operates to a standard that assures the reliability, quality and integrity of the work and results generated.