Data Standards Decisions is a family owned company who specializes in data standards consultancy, specifically for the nonclinical industry in CDISC SEND. The core business of the company is centered on the imminent and longer term needs in the nonclinical industry in achieving compliance to guidelines released from the Clinical Data Interchange Standards Consortium (CDISC), US Food and Drug Administration (FDA), (PMDA) and the European Medicines Agency (EMA).
Our lead consultant Gitte Frausing is an international recognized expert in the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data (CDISC SEND) model and Study Data Tabulation Model (CDISC SDTM). She is one of two authorized CDISC instructors in SEND globally.
Our services include consultancy, data review and test submission assessments, data conversion and training.