Leading Biotechnology Company Selects Instem's submit™ Software Suite
Company to Deploy submit™ for Complete SEND Management
CONSHOHOCKEN, PA – December 11, 2015 -Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that a major biotechnology company based in California has purchased its submit™ solution suite to automate the creation and management of nonclinical data in accordance with CDISC’s Standard for Exchange of Nonclinical Data (SEND).
In alignment with the FDA’s final Guidance for Standardized Study Data for providing regulatory submissions in electronic format (December 2014), Instem offers the submit™ solution suite of tools and services to address the complexities of creating, managing and storing SEND data. The biotechnology company’s team will deploy submit™ to efficiently prepare nonclinical data according to the required formats, standards and terminologies.
- The client will use submit™ to compile data from any source and efficiently convert it to SEND compliant datasets
- The company will also use Instem’s SENDView™ product to uniquely simplify the QC review and exploration of SEND datasets
- Submit™ to fully automate workflows for securing and processing datasets
- Submit™ suite includes a fully version-controlled file store of all data files and SEND datasets
Compliance with the SEND initiative is a market imperative for the entire drug development community. Companies around the world continue to choose the submit™ solution suite due to its proven results, combined with Instem’s unparalleled practical experience and SEND leadership. Instem experts help R&D teams across the industry to implement its submit™ solution to optimize SEND processes and help ensure complete and accurate submissions to the FDA.
Gary Mitchell, Vice President of Marketing at Instem said “We are elated to add a top biotechnology company to our rapidly growing submit™ client list. We look forward to partnering with their team to add value as they create, manage and submit SEND data more efficiently.”
Instem’s submit™-SEND tools and services are the most widely adopted in the industry, operating at over 34 sites across 12 countries. The Instem team has led and participated in the creation of the SEND standard for over 10 years and brings over 30 years of experience in developing, delivering and supporting world-class nonclinical systems and solutions for the scientific community.
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 Japan and India.
Meeting clients at the intersection of investment & return™.
Gary Mitchell (US HQ)
Julie Jones (UK HQ)
Tel: +44 (0) 1785 825600