Data Management
Apyx will build the submission data package (Module 5, ‘datasets’ folder) for your Marketing Application compliant with the FDA’s 1999 guidance or the CDISC Study Data Tabulation Model (SDTM).
We can prepare any data component in the appropriate format: Define.pdf, Define.xml, Annotated CRF, Tabulation datasets, Analysis datasets and Patient Profiles.
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News & Events
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Case Studies
Learn more about representative projects and challenges that large and small pharma face in the area of regulatory submissions and how Apyx has helped meet these challenges.