Digital Infuzion News

Tuesday, September 9, 2008

Digital Infuzion's CDISWITCH Updated

CDISWITCHTM, Digital Infuzion’s software tool that allows clinical researchers and research sponsors to seamlessly exchange valuable clinical data across industry standards, has been updated to support the recently published U.S. Food and Drug Administration (FDA) proposed rule for Electronic Submission of Data from Studies Evaluation Human Drugs and Biologics as detailed in the PDUFA IV Information Technology Plan. This standard, the Study Data Tabulation Model (SDTM), has been defined by the Clinical Data Interchange Consortium (CDISC). The SDTM will be the foundation for standardized clinical content at the FDA.