FOSTER CITY, Calif., Feb. 15, 2017 (GLOBE NEWSWIRE) -- PointCross Life Sciences came out of stealth mode with its Xbiom™ Insights solution for Clinical Biomarker research. With two clients deployed, PointCross is now acquiring new pharma and biotechnology companies who are pursuing precisely targeted therapies in oncology, central nervous system, and cardiovascular. Having proven the capability and value to researchers over the past year, the company has now formally launched its Xbiom™ big data platform.
In case you missed our announcement made in December 2016; PointCross is happy to announce availability of it’s Validator to the public free of charge.
RDIS™ and iOmics™ integration arcs across nonclinical, clinical and genomic biomarkers for targeted therapeutic drug development and stratified patient selection
CIMS™, the PointCross Life Science built Repository for Clinical SDTM Data is now available to Pharma sponsors with compliant standardized NDA submissions to FDA guidance.
XYBION AND POINTCROSS ESTABLISH A STRATEGIC PARTNERSHIP TO DELIVER SEND SERVICES TO ASSURE FDA REVIEW READY SUBMISSIONS
March 11, 2016: PointCross Life Sciences and Xybion announced today a strategic partnership to provide the Biopharma industry with a complete suite of data management, standards governance, data quality assurance and regulatory review solutions to comply with the FDA’s mandate requiring submission of CDISC SEND datasets starting in December 2016.
PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services
FOSTER CITY, Calif., Oct. 3, 2011 PRNewswire
PointCross Life Sciences Announces DSIMS™: Drug Safety Information Management Suite
FOSTER CITY, CA, 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.
PointCross Life Sciences Named to Gartner’s Cool Vendor 2013 List for Life Sciences
FOSTER CITY, CA, May 15, 2013
PointCross Life Sciences announced today that it has been included in the list of “Cool Vendors in Life Sciences, 2013” ¹ by Gartner, Inc. PointCross Life Sciences is a leading provider of solutions designed to unleash the value of data generated from nonclinical studies and clinical trials conducted by the BioPharma industry. The Gartner Cool Vendor 2013 Life Sciences report highlights select companies that offer novel tools to aggregate and deliver value from data for insight-driven performance improvements. PointCross Life Sciences supports the broad needs of translational informatics by providing robust big data stores that hold semantically harmonized and unit normalized data from studies and trials located in disparate, federated sources; and analytics to discover patterns and trends from these data for the purposes of research, safety and efficacy reviews.
PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions
FOSTER CITY, CA, June 6, 2013 PRNewswire
PointCross Life Sciences today announced the immediate availability of a multi-tenant software as a service (SaaS) environment to support the preparation and review of study datasets prior to their submission to the FDA’s NIMS (Nonclinical Information Management System) solution. These study data sets are not limited to the CDISC SEND 3.0 standard and they may include new domains and data types that Sponsor companies wish to review using the same tool sets used by the FDA.
PointCross Life Sciences Opens New Office in Silver Spring, Maryland for Data Standardization of Nonclinical Studies
FOSTER CITY, CA, July 9, 2013 PRNewswire