PointCross Blog

Benchmark your SEND Readiness

Our head of SEND Services and Chief Toxicologist at PointCross Life Sciences collaborated on a whitepaper on how to assess your SEND readiness. To access the full document, please click here. We have also summarized the document below. When we check nonclinical studies in SEND format with our SEND-ASSURE service, we find that there are significant inconsistencies...

PointCross Inks two deals for its Xbiom™ Insights – Clinical Biomarker Platform for Precision Medicine Development

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...

PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services

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...

PointCross Life Sciences Announces DSIMS™: Drug Safety Information Management Suite

PointCross Life Sciences Announces DSIMS™: Drug Safety Information Management Suite FOSTER CITY, CA, March 12, 2012 PRNewswireThe 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...

PointCross Life Sciences and Xybion forge strategic partnership to deliver SEND services to assure FDA review ready submissions

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...

PointCross Life Sciences and InterpretOmics partner for Clinical and Genomic Biomarker Management for Drug Development

RDIS™ and iOmics™ integration arcs across nonclinical, clinical and genomic biomarkers for targeted therapeutic drug development and stratified patient selection Foster City, CA, April 20, 2015 /PRNewswire/ — PointCross Life Sciences today announced a strategic partnership with InterpretOmics Pvt. Ltd. to provide an integrated Big Data and globally accessible environment for genomic interpretation and analysis...

PointCross Life Sciences’ Clinical Data Repository for SDTM data fills an urgent gap

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. Silver Spring, MD, March 14, 2016 PointCross Life Sciences today announced its formal release of CIMS™, a Hadoop (HDFS) based extensible repository. CIMS has extensive workflows and validations systems built-in for...

Introducing the PointCross Desktop Validator

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. To date, there is no validator available on the market which focuses solely on the validation of Non-Clinical ‘SEND’ and ‘Define.xml’ file data. Even, there is no other tool that...

PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions

FOSTER CITY, CA, June 6, 2013 PRNewswirePointCross 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...