PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services
FOSTER CITY, Calif., Oct. 3, 2011 PRNewswire
PointCross Life Sciences, Inc. has announced that it has been awarded an Indefinite Delivery Indefinite Quantity (IDIQ) contract by the U.S. Food and Drug Administration to provide an integrated off-the-shelf software environment comprising of a hosting repository, visualization and analysis functions, and search and discovery capabilities. This environment will enable FDA pharmacologists / toxicologist reviewers and statisticians to access, manipulate, and analyze nonclinical regulatory submissions in electronic formats including the CDISC Standard for the Exchange of Nonclinical Data (SEND). The software will also facilitate search and discovery across multiple studies for signal identification and validation of toxicity findings in order to better support science-based regulatory decision making.
In order to meet the Agency’s requirements, PointCross will deliver its nonclinical study data software suite consisting of a Nonclinical Study Data Repository (NSDR), Study Data Integration and Search module (SDIS™), the ToxVision++ Viewer, and the “SEND++ Server” module for data loading. Services provided under the contract include project management, software configuration and enhancement and data integration.
The FDA’s Center for Drug Evaluation and Research (CDER) has recognized that access to electronic structured scientific data about regulated products will improve science-based, regulatory decision making. The Agency anticipates nonclinical data will increasingly be submitted in electronic standard formats as the pharmaceutical and related industries adopt standards for data exchange, and that enabling informatics tools are required to process, search and review submitted data. CDER has been actively engaged in the development and testing of SEND, along with PointCross, and a number of Biopharma companies and CROs. According to Suresh Madhavan, CEO of PointCross, “The FDA’s decision to procure our nonclinical study software suite is a reflection of our thought leadership in delivering strategic search, data integration and standards-driven solutions and services to the Agency, the IMI eTOX Consortium and some of the largest sponsor companies in the Biopharma industry. It is a natural follow-on to the long-term CRADA that the FDA has maintained with us for the development of the reviewer-friendly ToxVision tool for data viewing and analysis. The FDA, as well as participating sponsor companies and CROs, have used ToxVision over the past four years as part of a CDER regulatory pilot for the SEND standard. We are enthusiastic about the Agency’s direction, and privileged to be an integral solutions provider in this exciting transformational phase of data exchange, workflows and submissions among CROs, sponsor companies and regulators.”
About PointCross Life Sciences, Inc.
PointCross Life Sciences, Inc. is a global technology provider of advanced strategic business solutions to knowledge-rich, decision centric markets in the Pharmaceutical and Biotech industries. We specialize in solutions for knowledge discovery, enterprise search, metadata management and decision processes. PointCross Life Sciences is a wholly owned subsidiary of PointCross, Inc.
For more information on our solutions contact:
Senior Vice President, PointCross Life Sciences, Inc.
1291 E. Hillsdale Blvd., Suite 304
Foster City, CA 94404