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Instem Recognized for Outstanding Contributions to SEND

Instem Receives Award for Leadership in its Support of Standard for Exchange of Nonclinical Data (SEND)

CONSHOHOCKEN, PA - February 28, 2012 - - Instem is pleased to announce that Vice President of Business Development, Jennifer Feldmann was recognized at the CDISC Interchange North America meeting for her outstanding contributions toward the completion of the SEND 3.0 Implementation Guide (“IG”).

FDA reviewers continue to receive mostly paper or electronic paper (PDF) submissions.  Manually entering this data for further analysis is time consuming and inefficient, taking time away from the primary mission of reviewing the content of submissions. The SEND format enables more efficient review of nonclinical data, offering improved data quality, accessibility and predictability.

The SEND 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).

 “I am very gratified to have our work on SEND recognized and I have been impressed by the commitment that the FDA has shown by their participation in SEND,” commented Jennifer Feldmann. “Using data in SEND format, the industry can help improve the safety review process while streamlining the flow of data from collection through submission and facilitate data interchange within their organizations and with external study partners.”

To help see the standard propagated throughout pharmaceutical companies and CROs worldwide for data exchange over the next few years, Instem has been providing education and outreach to promote SEND while demonstrating its own technology solution suite – submit™. Submit creates and manages SEND study datasets throughout their lifecycle, and allows sponsors, CRO’s and regulators to share, visualize and analyze study data more efficiently.

About Instem

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.

Meeting clients at the intersection of investment & return™.

Press Contacts:

Gary Mitchell (US HQ)
Tel: 610-941-0990

Julie Jones (UK HQ)
Tel: +44 (0) 1785 825600