CONSHOHOCKEN, Penn.—Instem, whose trademarked specialty is “Meeting clients at the intersection of investment and return” by providing IT solutions to the global early development healthcare market, recently participated in the Outsourcing Preclinical Development Conference in Berlin where company Vice President of European and Asian Operations Neil Donaldson addressed the gathering on “The Impact of SEND on Outsourced Studies” and outlined the status and industry deployment plans for the CDISC SEND (Standard for Exchange of Nonclinical Data) program. Outsourcing Preclinical Development is organized by Informa Life Sciences and is said to be Europe’s only preclinical outsourcing event.
What is CDISC? It’s the Clinical Data Interchange Standards Consortium (CDISC), which is billed as an open, multidisciplinary, neutral, 501(c)(3) non-profit standards developing organization (SDO) that has been working since its formation in 1997 to develop global standards and innovations to streamline medical research and ensure a link with healthcare.
Information about the Berlin outsourcing conference online doesn’t go into much detail about SEND, but a search for the Standard for Exchange of Nonclinical Data does lead to the U.S. Food and Drug Administration website. There you learn that “The Standard for Exchange of Non-Clinical Data (SEND) is an implementation of the Study Data Tabulation Model for nonclinical studies. This standard was developed by the Clinical Data Interchange Standards Consortium’s (CDISC) SEND Team for nonclinical data collected from animal toxicology studies.”
The FDA goes on to explain that the production version of the SEND Implementation Guide (IG) Version 3.0 (SENDIG 3.0) is now available at http://www.cdisc.org/send, and further that “It is expected that this implementation guide will evolve, particularly to accommodate additions for reproductive toxicology, safety pharmacology and veterinary studies. In addition, SEND and STDM terminology that will be used by SEND v3.0 is available at http://www.cdisc.org/send.”
Instem’s Donaldson said in a news release that “Instem has been a leading participant in the SEND initiative from the outset, and it is pleasing to see that the industry continues to actively embrace SEND. Numerous organizations are now utilizing Instem solutions to create and manage their SEND data sets.”
SEND defines the organization, structure and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and contract research organizations and for submission to the FDA.
Instem is a key proponent of the SEND initiative, Donaldson notes, and has been providing industry education and outreach to promote SEND while demonstrating its widely deployed technology solutions SENDView and Submit. “The SENDView application uniquely simplifies the review of SEND datasets,” Donaldson tells DDNews, “enabling the user to overcome hard-to-understand SEND concepts, view the data and its relationships in meaningful combinations and to easily keep track of their dataset review progress. The submit solution suite converts data from any source system into SEND files and allows sponsors, CROs and regulators to share, visualize and analyze study data more efficiently.”
During 2012 Instem was recognized at the CDISC Interchange North America meeting for its outstanding contributions toward the completion of the SEND 3.0 Implementation Guide. In addition, earlier this year Instem received the VOLTAGE Technology Innovator Award for its submit-SEND solution at a ceremony in Philadelphia.
Instem is a leading supplier of IT applications to the early development healthcare market delivering solutions for data collection, management and analysis across the research and development 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.
Instem’s portfolio of software solutions is designed to increase client productivity by automating study-related processes while offering the ability to generate new knowledge through the extraction and harmonization of actionable scientific information. Instem supports its clients through full-service offices in the United States, United Kingdom and China, with additional locations in India and Japan.