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Global Healthcare Leader Becomes SEND-Ready; Completes Purchase of Instem Submit Software Suite

International Pharma to Standardize Upon Instem's SEND Software Platform

CONSHOHOCKEN, PA - (BUSINESS WIRE) – November 19, 2014 - -Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that a Fortune 500 pharmaceutical leader has purchased its complete submit™ solution suite to support CDISC’s Standard for Exchange of Nonclinical Data (SEND).  

Instem’s submit solution suite 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.

The global pharmaceutical client invests over $5 billion per year in R&D related expenditures providing life enhancing products in over 100 countries.

Instem’s submit solution suite will enable this global client to manage SEND datasets for their entire study portfolio, regardless of where those studies are conducted, and will allow simplified data review and search while automating workflows to improve operational efficiencies concerning SEND. Submit will also provide the client with capabilities for define.XML and define.pdf creation, SEND rule checking and the secure version-controlled 21 CFR Part 11 storage of SEND files.

“Since 2004 we have been deeply involved with SEND, and having launched our first product in 2005 we are so very pleased to include another global powerhouse in the rapidly growing list of clients that have acknowledged our leadership position,” comments Gary Mitchell, VP Global Marketing at Instem. “Instem has been raising awareness, conducting training, consulting and providing data conversion services to help clients become SENDReady™. Following FDA’s issuance of draft guidance earlier this year, we have seen a surge in interest and orders for our submit software solution.”

Instem’s submit solution has been licensed to more than 30 sites in 10 countries and during 2013 won the VOLTAGE Award for technical innovation. Instem has been recognized by CDISC for its exceptional SEND contributions and remains an active member of PhUSE.

Key Facts

  • Global healthcare provider deploying Instem’s complete submit™-SEND software suite
  • Global provider deploying integrated software package, including capabilities for SEND file receipt and creation, data review and search, define.XML and define.pdf creation, SEND rule checking, secure version-controlled 21 CFR Part 11 storage of SEND files
  • Instem selected for SEND market leadership, product functionality and strong corporate reputation

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