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Clinovo Launches New Version of CDISC® Express, its CDISC SDTM Mapping Tool
Date:8/27/2013

the SDTM mapping needs of medical device companies,” explains Ale Gicqueau, President & CEO at Clinovo. “Our industry has a real need for a cost-efficient solution to convert legacy clinical data to CDISC, not only to meet the FDA requirements, but also facilitate data exchange and readability”. CDISC has been downloaded over 900 times since its launch mid-2011, by leading fortune 500 sponsor companies, as well as the Food and Drug Administration (FDA) and the Clinical Data Interchange Standards Consortium (CDISC) organization.

Clinovo recently signed a contract with a world leading nutrition and health company. Clinovo will provide SDTM conversion services and in-depth trainings including hands-on labs and application of knowledge using the clients’ own clinical data. Clinovo is a trusted CDISC® Registered Solutions Provider as well as Gold Member of the CDISC organization. The company has years of experience delivering SDTM conversion, training, and support services to pharmaceuticals and medical devices companies in the US and Europe. Clinovo also partners with CROs willing to help their clients make the move to CDISC standards.

Clinovo is also launching an 8-week evening class on CDISC standards to meet the growing demand by sponsor companies to build their internal expertise. The CDISC Standards: Theory and Application class is part of Clinovo’s TechTrainings and provides in-depth understanding of ODM, SDTM, ADaM and Define.XML. Students will learn through examples how to transform legacy data into CDISC standards. The use cases will include exchanging data, archival, and electronic submission to regulatory agencies such as the FDA submission. Visit clinovo.com/cdisc-techtrainin
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