Commonly Held Myths about the FDA’s CDISC Mandate

Peter Schaefer

Have you heard the FDA will require electronic submissions that use CDISC standardized study data? In my work at Certara, I’ve noticed there’s a lot of confusion, and even significant apprehension, surrounding this issue. To combat the misconceptions about what these regulations will mean for drug developers, I’ve compiled a list of common questions (and […]

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Topics: PK/PD Modeling and Simulation
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