KeeCYTOAsia17.pdf

CYTO Asia 2017 -- In any laboratory, regulated or non-regulated, the inclusion of quality control samples in every analytical run is advantageous, but when considering longitudinal data, or multicenter data, quality control (QC) samples are critical. In diagnostic clinical laboratories the use of internal cellular QC is an accepted practice, however, for assays supporting drug development and clinical trial testing the requirement of external QC is unclear. In this presentation, best practices for the use of QC in multi-center trials as well as some of the challenges will be discussed.