SEND Implementation Guide v3.1 Now Available
Study Design Coverage Expanded
CONSHOHOCKEN, PA - July 8, 2016 - The CDISC/SEND Leadership Team has announced that the CDISC/SEND Implementation Guide, v3.1 has now been released. This important extension of the SEND standard addresses issues identified in SEND 3.0, expands the range of study designs that can be accommodated and also resolves ambiguity in some of the timing variables.
The SEND Implementation Guide (IG) is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to the US Food and Drug Administration (FDA). The SENDIG is based upon, and should be used in conjunction with, the newly released Version 1.5 of the CDISC Study Data Tabulation Model (SDTM), which is included in the document package.
To access the document package interested parties are encouraged to visit the CDISC announcement www.cdisc.org/send.
Instem will be holding an Express Webcast that will provide an explanation of the changes to the standard, along with guidance on implementation considerations.
There will be two identical, live Webcasts that you can join right from your desktop, tablet or phone. Please register below:
Tuesday July 26th 9:30am – 10am US Eastern
Wednesday July 27th 1:30pm – 2pm US Eastern
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 now proud to provide the most widely adopted set of SEND tools and services in the industry, operating at 45 sites across 15 countries.
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 450 clients through full service offices in the United States, United Kingdom Japan, India and China.
Gary Mitchell (US HQ)
Julie Jones (UK HQ)
Tel: +44 (0) 1785 825600