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CDISC

CDISC

In accordance with US FDA standards, we prepare the CDISC Submission Package for you.

CDASH - Operational Database (ODS)
Tabulations (SDTM)
Analysis Datasets (ADaM)
Tables, Listings, Figures (TLF)
Specific validation
CDISC Submission Package

We will answer your questions regarding cdisc questions.
PD Dr. rer. nat. habil. Katrin Mittmann is at your disposal.