FDA awards $20M IDIQ contract to PointCross Life Sciences for enhancing NIMS to review Nonclinical eData submissions in SEND and NIMS compatible formats
FOSTER CITY, Calif., Sept. 26, 2013 /PRNewswire
PointCross Life Sciences, Inc. announced that it has been awarded an IDIQ contract with a cap of $20 Million by the U.S. Food and Drug Administration to provide software development and life cycle management of NIMS (Nonclinical Information Management System) as well as to standardize current study submissions to enable reviews in NIMS. PointCross will standardize non-electronic submissions from PDF, non-standardized electronic and CDISC® SDTM formats into CDISC SEND or extended data representations for studies that do not fit within prevailing standards. New extensions and data models to be developed under this contract include MCM (Medical Counter Measures), efficacy studies, safety pharmacology, and reproductive toxicology. This contract will extend NIMS to meet the FDA’s goals for better regulatory decision making and advancing computational sciences.
The FDA acquired DSIMS™ (Drug Safety Information Management Suite) from PointCross Life Sciences in October 2011 as the foundation for their NIMS application in an earlier contract. DSIMS™ includes study data repositories, analytics, and visualization of safety data and metadata for disparate types of studies and trials.
Highlighting the importance of this contract, Suresh Madhavan, CEO of PointCross said, “We believe the FDA’s award reflects their continued trust in PointCross to help the Agency meet their rapidly changing needs in computational and regulatory sciences. We look forward to serving the industry by freeing the flow of standardized eData for safety, research, and improving time to market of drug products.”