XML4Pharma Releases V.1.5 Of SDTM-ETL Software
XML4Pharma has released v.1.5 of its popular SDTM-ETL(TM) software for the generation of SDTM datasets for submissions to the FDA.
Online, January 21, 2011 (Newswire.com) - XML4Pharma, a software and consultancy company specialized in implementation of CDISC standards, has released v.1.5 of its popular SDTM-ETL(TM) software.
SDTM-ETL is the leading software for generation of SDTM datasets for submissions to the FDA starting from operational clinical data as extracted from most popular EDC and CDMS systems.
The new version has enhanced features for automated generation of SDTM Comment domains, with automated splitting of COVALn fields. Furthermore, the software now also implements the CDISC SEND v.3.0 standard.
For users of the OpenClinica EDC software, a special version of SDTM-ETL is now available that supports all CDISC-ODM vendor extensions as implemented in OpenClinica 3.0. As such, SDTM-ETL is the first choice for users of OpenClinica that want to generate SDTM datasets from their clinical data. Versions implementing ODM-extensions from other EDC vendors will also soon be available.
Further information is available at: www.XML4Pharma.com/SDTM-ETL/
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