FOSTER CITY, Calif., March 12, 2012 /PRNewswire/ -- The FDA has announced its intention to require Pharma companies to include nonclinical study data in standardized electronic formats as part of regulatory IND, NDA and BLA submissions. This directive is intended to help FDA reviewers better predict safety impacts of drugs in humans, and to improve regulatory science.
The FDA's announcement will require a dramatic shift from largely paper and PDF based processes used by Pharma companies and their contract research labs today to digital tabulated data formatted for direct machine readability. To help the industry with this important challenge, PointCross is announcing the immediate availability of its Drug Safety Information Management Suite (DSIMS) of solutions.
DSIMS is the software, repository, unified data model, viewer and analytical tools behind the FDA's Nonclinical Information Management Solution (NIMS). FDA reviewers will use NIMS to view, analyze and search submitted data for drug safety assessment. It has been adopted by leading Pharma companies who are looking for game changing technologies to better anticipate, evaluate and mitigate safety risks in their drug candidates.
DSIMS consists of a study data repository and modules for safety detection analytics, search, viewing and workflow processes. Collectively, these modules address the integration, governance and exploitation of nonclinical and translational data assets associated with drug development.
According to Dr. Shree Nath, VP of PointCross Life Sciences, "DSIMS is the right technology in the market providing the industry and the FDA with groundbreaking ways to exchange, interrogate and interpret all the nonclinical data collected for the purposes of drug safety and toxicity assessment. It has been proven to result in frictionless data flows across organizations and scientific teams leading to early identification of safety risks, dramatic productivity gains and cost savings."
DSIMS is immediately available as an enterprise solution or securely hosted by PointCross in the Amazon Cloud.
About PointCross Life Sciences, Inc.
PointCross Life Sciences, Inc. is a global technology provider delivering proven solutions to support drug safety development through a suite of information management repository solutions and services. These include safety biomarker detection and analytics, data validation, regulatory reviews and submissions support, and study data conversion services. Our clients include global Biopharma companies as well as the FDA. PointCross Life Sciences is a wholly owned subsidiary of PointCross, Inc.
SOURCE PointCross Life Sciences, Inc.