Leading Global Biopharma Purchases Instem SEND-submit Software Suite
US-Based International Biopharmaceutical Company Chooses submit™ Software to Convert, Create and Share SEND Data
CONSHOHOCKEN, PA - (BUSINESS WIRE) - December 5, 2012 - - Instem, a leading provider of IT solutions to the global early development healthcare market, announced today one of the world’s largest biopharmaceutical organizations has purchased their submit™ solution suite to support CDISC’s Standard for Exchange of Nonclinical Data (SEND).
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 US Food and Drug Administration (FDA).
- Biopharma client purchases Instem’s complete submit software solution suite to create and manage SEND datasets throughout their lifecycle
- Instem software to reduce client time and effort by translating study data to controlled terminology and automatically checking against SEND guidelines to ensure compliance
- Instem’s newly announced SENDView™ solution for simplified data review part of submit delivery package
- Purchase additionally includes capability for management, secure storage and sharing of SEND datasets with external partners
- Fully integrated validation solution being utilized for rapid and comprehensive deployment
“As a member of the CDISC SEND committee, I’m encouraged to see a top 10 biopharma moving aggressively to leverage the value of standardized nonclinical data in advance of the FDA requirements,” comments Jennifer Feldmann, VP Business Development at Instem. “They have clearly seen the benefits of submit as a fully-integrated solution for SEND file preparation, review, management and exchange, and we are looking forward to working with yet another Fortune 500 company as industry responds to this critical standard.”
Enhancing the submit solution suite, Instem recently introduced SENDView, a new tool for simplifying the review of SEND datasets; enabling users to overcome hard-to-understand SEND concepts, view the data and its relationships in meaningful combinations while easily keeping track of their dataset review progress. SENDView is available as part of the submit suite or as an independent solution which can be used with any SEND dataset regardless of how it was produced.
The US-headquartered client generates over $20 billion in net sales annually with $3 billion being spent in research & development as they advance their mission to discover, develop and deliver innovative medicine to cure the most serious of diseases.
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™.
Gary Mitchell (US HQ)
Julie Jones (UK HQ)
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