Updates advance the mission of the FDA’s new Quantitative Medicine Center of Excellence, which seeks to leverage biosimulation for therapeutic medical product development and inform regulatory decision-making. RADNOR, PA —…
Learn more about how our pharmacometricians can help you de-risk your drug development program. Transcript: Hello, and welcome to Certara Talks. My name is doctor Suzanne Minton, and I’m a…
The Phoenix UGM featured industry expert insights, peer networking, and glimpses into the latest PK/PD modeling and simulation software innovations.
Targeted radiation therapies (TRT) deliver cytotoxic radiation selectively to tumors. In recent years, oncology drug developers have increased their interest in this therapeutic class. However, the regulatory landscape is still…
Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand how they work and how to use them.
In this abstract, Julie Ann Hood and Jennifer Manzi look at how you can improve your SDTM Validation with the magic of Data Managers.
Learn how one CRO uses Pinnacle 21 to optimize sponsors’ clinical regulatory affairs, saving time and improving stakeholder communication.
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