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VDataWare CSR
The CSR module of VDataWare application is designed to enable the rapid creation of CDISC SDTMs, clinical study analysis datasets (ADaMs), submission-ready safety and efficacy tables, listings and graphs (TLGs) and patient profiles. Its web based Graphical User Interface [GUI] allows targeted end users to review and produce tables and listings during the conduct of a clinical study. End users can customize contents of a report using sub-setting and parameter selection options.
Key features:
Reduces the programming effort needed to create safety and efficacy tables by standardizing the table/listings
layout
Ensures quality and consistency of output by using validated templates
End users should be familiar with the standard TLG layout that is being applied across all studies
Allows the end user to subset the data and selection of identified parameters to create dynamic reports
Follows CDISC standards, ICH E3 and other related guidelines