Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy

Cowan K, Golob M, Goodman J, et al. | Bioanalysis, 14(13), 911 - 917 (2022) Keywords: • assays • biomarkers • context of use Since 2011, the European Bioanalysis Forum has been discussing the topic of context-of-use for biomarker assays, in support of a cross-industry implementation of its principles. The discussions have led to the acknowledgement of the challenges that we face as an industry in implementing these principles. In addition to scientific recommendations, the European Bioanalysis Forum has addressed these challenges by providing recommendations on organizational design, and what works in both sponsor and contract research organizations, to support...