Assembling an Operations Team

Drug Discovery Toxicology From Target Assessment to Translational Biomarkers, First Edition. Edited by Yvonne Will, J. Eric McDuffie, Andrew J. Olaharski, and Brandon D. Jeffy. 

BEST PRACTICES IN EVALUATING NOVEL BIOMARKER FIT FOR PURPOSE AND TRANSLATABILITY 

FIGURE 42.1 Operations team schematic. The study sponsor assembles a team to integrate sample collections at the point of clinical care with hiomarker storage and analysis using validated assays. The samples may be submitted for immediate biomarker analysis and/or may be biobanked for future analysis. Data generated from biomarker analysis is collected and stored and forwarded to the data team for analysis using the statistical approaches described in the study sponsor protocol. 

---