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For life-science organizations managing the operational side of this compliance question, the challenge increasingly resembles a data and systems problem as much as a clinical one: enrollment goals must be tracked, disaggregated by race, ethnicity, sex, and age, against real-time site-level recruitment data, and reconciled with disease-prevalence benchmarks that sponsors must be prepared to justify to FDA
Interactions between subunits of the Mediator complex with gene-specific transcription factors
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