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Leading Contract Research Organization Selects Instem SEND Software Suite

CRO to Deploy Submit Software Suite for Complete SEND Management

CONSHOHOCKEN, PA – November 3, 2014 - -Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that a Top 5 Contract Research Organization (CRO) has selected Instem’s submit™ solution suite to support CDISC’s Standard for Exchange of Nonclinical Data (SEND).  

Headquartered in the U.S., the CRO serves Sponsors from 30 different countries and is sought after for their regulatory experience and track record of success in all major global markets. The CRO provides safety evaluation, discovery, bioanalytical and analytical services to the biopharmaceutical, medical device and chemical industries.

Instem’s submit solution suite creates and manages SEND study data sets throughout their lifecycle and allows sponsors, CRO’s and regulators to share, visualize and analyze study data more efficiently.

Instem’s submit software solution will enable this leading CRO to merge data from multiple sources and automate workflows to improve their operational efficiencies while simplifying day-to-day operations around SEND. Using the SENDView™ module, which can be integrated with submit or used stand-alone, will additionally allow the CRO to view SEND files for simplified data review and study search.

“Clients are finding that our submit-SEND solution is efficient, compliant and complete – and of course extremely powerful,” comments Gary Mitchell, VP Global Marketing at Instem. “Using submit, CRO’s are able to meet and exceed the expectations of their Sponsors for SEND without placing additional burdens on their research and IT staff. Our SEND solution was launched in 2005, is market proven and with 30 licensed sites and growing, we have gained the confidence of organizations around the globe as their SEND management experts.”

Instem has been involved with SEND since 2004, has been recognized by CDISC for its exceptional SEND contributions and remains an active member of PhUSE.

Key Facts

  • Leading CRO Purchases Instem submit software to support SEND
  • U.S.-headquartered CRO deploying integrated submit package including capabilities for SEND file receipt and creation, data review and search, define.XML and define.pdf creation, automatic term translations, SEND rule checking, secure version-controlled 21 CFR Part 11 storage of SEND files
  • Leading CRO selects Instem for SEND market leadership, proven product capabilities and corporate stability

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