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 format datasets, PHASTAR can upgrade these to CDISC compliant datasets (SDTM and ADaM).  We can provide all the necessary associated documentation that a submission to the FDA will require (or other global regulators), including annotated CRFs, define.xml and/or define.pdf and a regulatory reviewer's guide.  If you are planning an integrated summary of efficacy and safety, we can help put together CDISC compliant datasets. We can also provide advice on the format of the data that will be acceptable to global regulatory bodies.