The WebSDM tool was originally developed under a Cooperative Research and Development Agreement (CRADA) for the FDA to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format, and has been installed at FDA since 2005.
The WebSDM tool was originally developed under a Cooperative Research and Development Agreement (CRADA) for the FDA to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format, and has been installed at FDA since 2005.
The tool was adapted from a current feature of Phase Forward s WebSDM product, which was developed under a Cooperative Research and Development Agreement (CRADA) for the FDA to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format.
Empirica Study is an award-winning product that provides a dynamic visual data environment for reviewing safety data and detecting signals in trial data in CDISC Study Data Tabulation Model (SDTM) format.
The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) has become the preferred standard for companies submitting electronic data to the FDA and integrating clinical data sets from multiple sources.
WebSDM allows users to load study data in the Study Data Tabulation Model (SDTM) format developed by the Clinical Data Interchange Standards Consortium (CDISC) as well as check and correct errors and inconsistencies, and browse data in a variety of tabular and graphical formats.
The WebSDM software supports the validation and review of clinical trials study data submitted by bio-pharmaceutical companies in the Study Data Tabulation Model (SDTM) format developed by the Clinical Data Interchange Standards Consortium (CDISC).
The WebSDM software supports the validation and review of clinical trials study data submitted by bio-pharmaceutical companies in the Study Data Tabulation Model (SDTM) format developed by the Clinical Data Interchange Standards Consortium (CDISC).
