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Updated: Aug 14, 2026

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
[Good practices in clinical trials. Quality control of biological trials in hospital laboratory]
1Laboratoire de Biochimie, Hôpital Saint-Louis, Paris.
Abstract:
All along clinical studies of a new drug, during the second, third, or fourth phase, the hospital laboratory occurs in the biological tolerance supervision. Therefore, it calls on a number of quality controls, either voluntary or obligatory: patient identity control, analytical quality controls: between and within laboratory, regional and national controls, biological quality control. Beside these quality controls, that are necessary at the same time for clinical studies and for routine analysis, biological laboratories are submitted on norms of material, area, and employees qualification (Law of July 11th 1975).
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