Through proactive protocol design and targeted clinical trial operational models, the sample collection process for all in vitro diagnostics (IVDs) can be managed in increments that allow for development of the diagnostic and/or allow for decisions to be made at any time regarding the viability or robustness of the diagnostic and the need for more development work or to finalize the diagnostic sensitivity and specificity desired as well as the establishment of the intended use. This session will address biostatistical models, proper site selection, and data management tools to be used for central and onsite monitoring, and sample collection processing and handling procedures to reduce induced error. The session will cover models which should be used for diagnostic, predictive and companion diagnostics, and human factors studies.