PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions
FOSTER CITY, Calif., June 6, 2013 /PRNewswire/ — PointCross Life Sciences today announced the immediate availability of a multi-tenant software as a service (SaaS) environment to support the preparation and review of study datasets prior to their submission to the FDA’s NIMS (Nonclinical Information Management System) solution. These study data sets are not limited to the CDISC SEND 3.0 standard and they may include new domains and data types that Sponsor companies wish to review using the same tool sets used by the FDA.
NIMS is the FDA’s implementation of the PointCross DSIMS (Drug Safety Information Management Suite) for the review, visualization and analysis of submitted datasets. PointCross Life Sciences has developed and implemented a noSQL methodology for storing and analyzing GLP and non-GLP studies, including safety pharmacology, reproductive toxicology, and animal rule studies that are not covered by the SEND 3.0 standard. PointCross will provide the software as a service (SaaS) hosted in the cloud and complement it with services to model study types not included in the present NIMS model and then make them available for Sponsor submission 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 Study Data Conversion 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. PointCross Life Sciences is a wholly owned subsidiary of PointCross, Inc.
SOURCE PointCross Life Sciences, Inc.