CDASH Services for Clinical Trials
What is CDASH in Clinical Trials?
CDASH is a CDISC standard used to collect clinical trial data (at the eCRF/EDC level) in a well-structured and consistent way. CDASH stands for Clinical Data Acquisition Standards Harmonization and provides guidance and best practices to design the eCRF/EDC based on standardized domains and variable names. Sponsors submitting data to regulatory authorities (such as the FDA) will need to apply CDASH principles to their data collection tools.
Sofpromed’s CDISC Services
Sofpromed is a biometrics CRO specialized in providing CDISC services for small biotech and biopharmaceutical companies. Our CDISC capabilities include the implementation of CDASH, SDTM and ADaM standards. Sofpromed’s CDISC services are oriented to phase I-IV clinical trials in various therapeutic areas such as oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious, and respiratory diseases, among others.