The FDA has adopted the CDISC SDTM standard for clinical trial submission. While the standard has the potential to simplify the reporting processes, adoption poses challenges to and raises questions...
With CDISC Adoption by FDA, Managing Clinical Trial Metadata with Semantic Technology Has Emerged Front and Center!
As FDA outlines, “the submission of standardized study data enhances a reviewer’s ability to more fully understand and characterize the efficacy and safety of a medical product,” and adopted CDISC...