PointCross Life Sciences has been awarded an Indefinite Delivery Indefinite Quantity (IDIQ) contract by the FDA 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.