Many pharmaceutical and biotech companies implement CDISC standards when creating databases for new clinical studies. Regulatory authorities have found the use of CDISC has made it more efficient for them to review and examine information.
This includes legacy studies with valuable data that have not been conducted to this standard. This can create issues when trying to integrate data from different studies which often requires considerable mapping work.
Conversion to CDISC standards generally includes SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model) and CDASH (Clinical Data Acquisition Standards Harmonization). It is important to start implementing CDISC standards during data collection by having Data Managers design the CRF using CDASH standards.
CROS NT is a CDISC Gold Member, meaning it has constant access to new data standards and new documentation regarding CDISC standards.