SDTM Services for Clinical Trials
What is SDTM in Clinical Trials?
SDTM is a CDISC standard used to tabulate and submit clinical trial datasets to regulatory authorities such as the FDA of the United States. SDTM stands for Study Data Tabulation Model and has become a global standard for the regulatory submission of clinical trial data. Sponsors conducting commercial trials will need to apply the SDTM standard to their clinical datasets.
Sofpromed’s CDISC Services
Sofpromed is a biometrics clinical research organization (CRO) specialized in providing CDISC services for clinical trial sponsors worldwide. Our CDISC capabilities include the implementation of CDASH, SDTM and ADaM standards. Sofpromed’s CDISC services are ideal for biotech and pharma companies running clinical studies in oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious, and respiratory diseases, among other therapeutic areas.