SENDIG v3.1 Draft B Now on Public Review
Comments due by September 10, 2015
August 17, 2015 – The CDISC/SEND Leadership Team has announced that the second draft of the CDISC/SEND Implementation Guide, v3.1, is now available for public comment. This draft addresses issues identified by the first public comment period in December 2014, and also resolves ambiguity in some of the timing variables.
To access the document package and provide comments, interested parties are encouraged to visit the CDISC announcement www.cdisc.org/send.
Instem has been extensively involved in the creation and development of SEND since its inception, working closely with SEND pilot organizations, the FDA and industry to help define the standard and align it with industry practices.
As a result of this detailed involvement, Instem developed submit™, the first commercially available SEND data management system and is proud to provide the most widely adopted set of SEND tools in the market, with Instem SEND solutions licensed across 12 countries at 35 sites.
Instem’s submit platform provides a suite of integrated tools and services for the creation and management of SEND datasets and associated documents for Contract Research Organizations, Sponsors and their study partners. More information about SEND and Instem’s tools.
Instem is a leading supplier of IT applications to the early development healthcare market delivering compelling solutions for data collection, management and analysis across the R&D continuum. Instem applications are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making, leading to safer, more effective products.
Instem’s portfolio of software solutions increases client productivity by automating study-related processes while offering the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Instem supports over 400 clients through full service offices in the United States, United Kingdom and China with additional locations in Japan and India.
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Gary Mitchell (US HQ)
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