As CDISC authorized trainers in SDTM and ADaM, we provide expertise about requirements, processes, systems, as well as consultants experienced in implementing these standards.
We have advised several major pharmaceutical companies all the way from first steps of implementing CDISC through to full implementation. S-cubed’s consultants have converted over 100 studies to CDISC standards and supported more than 20 successful FDA submissions. Having worked with CDISC standards since 2004, we are very familiar with issues that typically arise and have unique insight about what works well.
The United States Food and Drug Administration recommends using CDISC (SDTM) standards for electronic submissions of all clinical data, and requires compliance with CDISC standards for all new clinical studies starting after December 2016. The European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency have also expressed intention to require CDISC.