standards

Changing technology in health sciences means more data sources, more study designs that weren't available in the past. The good news? All this additional data provides greater evidence and insights into the benefits and risks of a medical product. This sharp increase in the use of non-randomized clinical trials study designs, Electronic Health Records (EHRs), Registry, and other observational studies has placed a spotlight on the need to consider alternatives to the CDISC standards developed 20+ years ago to support marketing applications. For now, all data must be submitted using CDISC standards, so RWD must be transformed or converted to meet to meet the CDSIC requirement standards specified in the guidance. Is there a better way?