Making your data fit the model

The U.S. Food and Drug Administration’s (FDA) request that all data, including legacy data, be submitted according to CDISC standards has put additional strain on the already limited resources of biopharmaceutical companies. By working in close partnership with Kendle, these strains can be eliminated.

We are unrivaled in our understanding and expertise of the CDISC process. Kendle has worked with the FDA on the CDISC program since its outset in 2003, when we mapped our first study into the Study Data Tabulation Model standard. CDISC is Kendle’s default standard and to date, the FDA has accepted six product submissions from us, formatted using CDISC’s SDTM and ADaM standards. In addition, we have mapped and delivered more than 110 SDTM and 270 ADaM documents.