PointCross Life Sciences, a PointCross company, has secured a $20m indefinite delivery, indefinite quantity (IDIQ) contract from the U.S. Food and Drug Administration (FDA) for providing software development and life cycle management of Nonclinical Information Management System (NIMS) and also to standardize current study submissions to enable reviews in NIMS.
Under the deal, PointCross Life Sciences will standardize non-electronic submissions from portable document format (PDF), non-standardized electronic and CDISC study data tabulation mode (SDTM) formats into CDISC standard for exchange of nonclinical data (SEND) or extended data representations for studies that do not fit within prevailing standards.
The company' s IDIQ contract calls for the development of new extensions and data models of medical counter measures (MCM), efficacy studies, safety pharmacology, and reproductive toxicology.
PointCross CEO Suresh Madhavan said the company believes 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," Madhavan added.
This contract is expected to serve the FDA's goals for better regulatory decision making and advancing computational sciences by extending NIMS.
In October 2011, PointCross Life Sciences provided DSIMS (Drug Safety Information Management Suite) to the FDA as the foundation for the administration's NIMS application.
DSIMS has study data repositories, analytics, and visualization of safety data and metadata for disparate types of studies and trials.
