Leading R&D Organizations Deploy Instem SEND Solutions
Organizations Around the Globe Continue to Become SEND-Enabled with Instem’s Submit Software Platform Following 2014 FDA Mandate
CONSHOHOCKEN, PA - (BUSINESS WIRE) – July 1, 2015 - -Instem, a leading provider of IT solutions to the global early development healthcare market, is pleased to announce that its customers are deploying Instem SEND solutions at a record pace. Numerous world- leading healthcare organizations have recently completed their deployment of Instem’s submit™ software platform enabling them to fully support CDISC’s Standard for Exchange of Nonclinical Data (SEND).
In December 2014, the FDA issued the final Guidance for providing Regulatory Submissions in Electronic Format using standardized Study Data. 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 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 leadership position has also attracted prominent SEND subject matter experts to join Instem, including Lou Ann Kramer, Instem’s VP Regulatory Submissions and current CDISC SEND team leader.
“We are delighted to see members of our global SEND client community such as Allergan, Charles River, MPI Research and many others continue to implement submit to meet the requirements of SEND,” comments Mike Harwood, Senior Vice President, Instem. “Enabling these clients with our proven technologies will give them real advantages with upcoming submissions.”
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 at http://www.instem.com/industries/send.php
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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