NIMS enables faster, deeper and more insightful regulatory review of nonclinical study data for safety signal detection and analysis
Silver Spring, MD, March 12, 2015/ PRNewswire
PointCross Life Sciences today announced that the FDA has accepted NIMS version 2.5 for operational use to review nonclinical CDISC SEND data that accompany NDA, BLA and IND drug applications. NIMS is the FDA’s deployment of the PointCross DSIMS™ product for accessing, storing, analyzing and reporting of standardized nonclinical electronic data.
The same version of DSIMS is now available to sponsors and CROs who need to prepare, analyze or visualize study data like FDA reviewers. NIMS automates the preparation of analytics views allowing FDA regulatory reviewers to perform in seconds complex analyses and visualization of sponsor data that previously took days or even weeks. It provides new facilities to check for data quality and compliance with FDA specific SEND data fitness rules. Coupled with the FDA’s Nonclinical JumpStart Service supported by PointCross, reviewers now have access to advanced analytics tools as well as to experts with extensive experience in assessing data quality, sufficiency and readiness for regulatory review.
Highlighting the timing of this product release, Prasanna Sadashivaiah, DSIMS Product Manager, PointCross Life Sciences said, “The FDA’s approval of NIMS 2.5 coupled with the services we provide to the JumpStart Nonclinical program exemplifies the preparation and attention to data packaging and quality that submitting sponsors must establish well in advance of the deadline imposed by the FDA in its December 2014 regulatory submissions guidance“.
About PointCross Life Sciences
PointCross Life Sciences provides the life sciences industry with data management, analytics and visualization solutions that reduce risks, improve data quality, shorten time to market, and generate better insights from R&D and regulatory data. The SEND offerings we provide include DSIMS, our commercial review product deployed as NIMS at the FDA, and the related SEND-ASSURE and Data Standardization solutions. We are a registered CDISC solution provider and collaborate with consortia like PhUSE. PointCross was recognized in 2013 as one of Gartner’s Cool Vendors in Life Sciences.
Dr. Shree Nath, Vice President,
PointCross Life Sciences, Inc.
1291 E. Hillsdale Blvd., Suite 304
Foster City, CA 94404