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United States: Phase Forward extends agreement with FDA for WebSDM software.


Byline: Mamta03

Phase Forward, the US company that specialises in data management solutions for clinical trials and drug safety, has extended its agreement with the US Food and Drug Administration for use of the company s WebSDM software in reviewing standardised electronic data submissions from clinical studies.

The WebSDM (Web Submission Data Manager) application was developed under a Co-operative Research and Development Agreement between the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 and Phase Forward s Lincoln Safety Group. The software has been in use at the agency since 2004 and is now commercially available to the clinical data management community.

WebSDM allows users to load study data in the Study Data Tabulation tab·u·late  
tr.v. tab·u·lat·ed, tab·u·lat·ing, tab·u·lates
1. To arrange in tabular form; condense and list.

2. To cut or form with a plane surface.

adj.
Having a plane surface.
 Model (SDTM SDTM Study Data Tabulation Model
SDTM Straight Down the Middle (pinball wizard terminology) 
) format developed by the Clinical Data Interchange Standards Consortium Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization, whose mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of  (CDISC CDISC Clinical Data Interchange Standards Consortium ) as well as check and correct errors and inconsistencies, and browse data in a variety of tabular and graphical formats. The CDISC is a US-based body set up to develop and support global, platform-independent data standards that enable interoperability of information systems to improve medical research and related areas of healthcare.

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Publication:TendersInfo
Date:Jan 21, 2009
Words:183
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