SEND Update - Public Comment Period Opens for Developmental and Reproductive Toxicology Studies
Comments due by August 13th 2015
July 15, 2015 - - The CDISC/SEND Leadership Team has announced that the Public Review period for the CDISC SEND Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.0 is now open, with comments due by August 13th 2015.
The CDISC SEND Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.0 draft supports study data typically found in embryo-fetal developmental (EFD) toxicity studies and is based on the SEND Implementation Guide Version 3.0. While this release (v1.0) focuses on EFD, other study designs will be covered in future releases.
To access the document package and provide comments, all interested parties are encouraged to visit the CDISC Public Comment Tracker tool. Reviewers will need to login or register for a CDISC portal account to use the tool. Help is also available on the Public Comment Tracker page Instructions on using the Public Comment Tool
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. Instem is an active participant in the CDISC Reproductive Toxicology Sub Team.
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 11 countries at over 32 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 can be found here.
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 India and a full service distributor based in Japan.
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Julie Jones (UK HQ)
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Gary Mitchell (US HQ)