Every drug approval rests on data, and that data has to arrive at regulators in a precise, standardized form. The professionals who do this work, clinical statistical programmers, operate largely out of public view. Their standards shift constantly. FDA requirements evolve, CDISC publishes new implementation guides, and formats dating back to the 1980s are finally […]
from
https://alltechmagazine.com/varun-debbeti-on-building-clinstandards-org/
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