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FOSTER CITY, Calif., July 9, 2013 /PRNewswire/ -- Extending its recently announced Data Standardization Service, PointCross Life Sciences announced that it has opened a new center in Silver Spring, MD, USA where studies submitted by sponsors to the FDA in PDF and other formats will be standardized to fit into the Agency’s NIMS (Nonclinical Information Management System) environment. Increased access to such structured study data combined with computational review tools in NIMS are aligned with the Agency’s goals of integrating regulatory history into scientific information and advancing regulatory science research.
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The PointCross team in the Maryland center applies the same methodology, processes, computational tools and information security controls used by other centers at PointCross Life Sciences. It will focus on standardization of studies already submitted to the FDA.
New studies that require extensions to the NIMS data model to handle novel protocols, innovative studies and new study types will be modeled and provided to the FDA.
About PointCross Life Sciences, Inc.
PointCross Life Sciences, Inc. is a global provider of Big Data analytics, data store and translational informatics solutions and Data Standardization Services designed for large, complex, and weakly structured datasets. Our offerings are used by researchers and reviewers involved with drug development, and are available behind the Enterprise firewall or on the Cloud. Our clients include several global Biopharma companies and the FDA. The FDA’s NIMS solution is based on PointCross’ DSIMS platform. PointCross Life Sciences is a wholly owned subsidiary of PointCross, Inc.
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