CDISC

       

CDISC

PHASTAR's Programming Division provides CDISC services, in particular, the creation of SDTM and ADaM datasets, as well as the development of dataset specifications.

If you have a submission approaching with legacy datasets, PHASTAR can upgrade these to CDISC compliant datasets.  We can provide all the necessary associated documentation that a submission to the FDA will require, including annotated CRFs, define.xml and/or define.pdf.  If you are planning an integrated summary of efficacy and safety, we can help put together CDISC compliant datasets.