--- title: Blog | PointCross Life Sciences --- [![Pointcrosslifesciences](https://blog.pointcrosslifesciences.com/hs-fs/hubfs/PointCross-Oct2016/Image/pcls-logo_white.png?width=244&height=39&name=pcls-logo_white.png "Pointcrosslifesciences")](http://www.pointcrosslifesciences.com/) [![Pointcrosslifesciences](https://blog.pointcrosslifesciences.com/hubfs/PointCross-Oct2016/Image/pcls-logo.png "Pointcrosslifesciences")](http://www.pointcrosslifesciences.com/) [+1 (866) 468-1900](tel:+1%20(866)%20468-1900) - [Xbiom™ Platform](http://www.pointcrosslifesciences.com/index.php/xbiom-platform/) - Solutions - [Clinical Trial & Molecular Biomarker Research](http://www.pointcrosslifesciences.com/index.php/clinical-research-development/) - [Clinical Regulatory Compliance](http://www.pointcrosslifesciences.com/index.php/clinical-regulatory-compliance/) - [Non-Clinical Cross-Study Analytics & Warehousing](http://www.pointcrosslifesciences.com/index.php/non-clinical-cross-study-analytics-warehousing/) - [Non-Clinical Regulatory Compliance](http://www.pointcrosslifesciences.com/index.php/non-clinical-regulatory-compliance/) - [eDataValidator](https://info.pointcrosslifesciences.com/edatavalidatordownload) - [MySEND](http://info.pointcrosslifesciences.com/mysend) - Resources - [Clinical Resources](http://www.pointcrosslifesciences.com/index.php/clinical-resources/) - [Non-Clinical Resources](http://www.pointcrosslifesciences.com/index.php/non-clinical-resources/) - [All Resources](http://www.pointcrosslifesciences.com/index.php/all-resources/) - [Company](http://www.pointcrosslifesciences.com/pc/?p=4367) - [About Us](http://www.pointcrosslifesciences.com/index.php/about-us/) - [Partners](http://www.pointcrosslifesciences.com/index.php/partners/) - [Careers](http://www.pointcrosslifesciences.com/index.php/careers/) - [Contact](http://www.pointcrosslifesciences.com/index.php/contact/) - [Xbiom™ Platform](http://www.pointcrosslifesciences.com/index.php/xbiom-platform/) - Solutions - [Clinical Trial & Molecular Biomarker Research](http://www.pointcrosslifesciences.com/index.php/clinical-research-development/) - [Clinical Regulatory Compliance](http://www.pointcrosslifesciences.com/index.php/clinical-regulatory-compliance/) - [Non-Clinical Cross-Study Analytics & Warehousing](http://www.pointcrosslifesciences.com/index.php/non-clinical-cross-study-analytics-warehousing/) - [Non-Clinical Regulatory Compliance](http://www.pointcrosslifesciences.com/index.php/non-clinical-regulatory-compliance/) - [eDataValidator](https://info.pointcrosslifesciences.com/edatavalidatordownload) - [MySEND](http://info.pointcrosslifesciences.com/mysend) - Resources - [Clinical Resources](http://www.pointcrosslifesciences.com/index.php/clinical-resources/) - [Non-Clinical Resources](http://www.pointcrosslifesciences.com/index.php/non-clinical-resources/) - [All Resources](http://www.pointcrosslifesciences.com/index.php/all-resources/) - [Company](http://www.pointcrosslifesciences.com/pc/?p=4367) - [About Us](http://www.pointcrosslifesciences.com/index.php/about-us/) - [Partners](http://www.pointcrosslifesciences.com/index.php/partners/) - [Careers](http://www.pointcrosslifesciences.com/index.php/careers/) - [Contact](http://www.pointcrosslifesciences.com/index.php/contact/) - [](https://www.facebook.com/pages/Pointcross-Life-Sciences/484062895006542?fref=ts) - [](http://twitter.com/PointCross_LS) - [](http://www.youtube.com/user/PointCrossInc?ob=0&feature=results_main) - [](https://plus.google.com/u/0/b/107708286878676756935/107708286878676756935/posts) - [](http://www.linkedin.com/company/pointcross-life-sciences/) # PointCross Life Sciences Blog ## [Benchmark your SEND Readiness](https://blog.pointcrosslifesciences.com/send-readiness) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 29, 2018, 9:23:46 PM - [Tweet](https://twitter.com/share) | 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 between the SEND data sets and the data reported in the Study Report. The overall quality of the SEND data set is classified in terms of: Conformance to standards and business rules Consistency with the audited Study Report in PDF, and Quality of SEND data packaging, Trial Summary, Define.xml, and nSDRG Across a dozen studies we found that SEND conformance did not meet the requirements for data being correct and consistent with the Study Report – which is the only audited data in a study’s submission. We have found that no studies are completely consistent.  This chart shows the average number of substantial inconsistencies across these dozen studies.   Read more about what this means in terms of SEND Readiness and what can be done to ensure that your studies are ready to be submitted.       | | --- | |   | |   | [Read More](https://blog.pointcrosslifesciences.com/send-readiness) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/send-readiness#comments-listing) Topics: [Insider](https://blog.pointcrosslifesciences.com/topic/insider), [SEND](https://blog.pointcrosslifesciences.com/topic/send), [life sciences](https://blog.pointcrosslifesciences.com/topic/life-sciences), [pharma](https://blog.pointcrosslifesciences.com/topic/pharma), [biotech](https://blog.pointcrosslifesciences.com/topic/biotech), [software](https://blog.pointcrosslifesciences.com/topic/software) ## [PointCross Inks two deals for its Xbiom™ Insights – Clinical Biomarker Platform for Precision Medicine Development](https://blog.pointcrosslifesciences.com/pointcross-inks-two-deals-for-its-xbiom-insights-clinical-biomarker-platform-for-precision-medicine-development) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Feb 16, 2017, 1:21:54 AM - [Tweet](https://twitter.com/share) [![](https://blog.pointcrosslifesciences.com/hubfs/Why-Big-Data-is-Essential-for-Success-in-the-Pharmaceutical-Market.png)](https://blog.pointcrosslifesciences.com/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 the capability and value to researchers over the past year, the company has now formally launched its Xbiom™ big data platform. [Read More](https://blog.pointcrosslifesciences.com/pointcross-inks-two-deals-for-its-xbiom-insights-clinical-biomarker-platform-for-precision-medicine-development) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/pointcross-inks-two-deals-for-its-xbiom-insights-clinical-biomarker-platform-for-precision-medicine-development#comments-listing) ## [Introducing the PointCross Desktop Validator](https://blog.pointcrosslifesciences.com/introducing-the-pointcrosss-desktop-validator-0) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 20, 2017, 1:29:04 AM - [Tweet](https://twitter.com/share) [![](https://blog.pointcrosslifesciences.com/hubfs/PointCross%20Validator%20Download.png)](https://blog.pointcrosslifesciences.com/introducing-the-pointcrosss-desktop-validator-0) In case you missed our announcement made in December 2016; **PointCross** is happy to announce availability of it’s [Validator](http://info.pointcrosslifesciences.com/validator) to the public free of charge. [Read More](https://blog.pointcrosslifesciences.com/introducing-the-pointcrosss-desktop-validator-0) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/introducing-the-pointcrosss-desktop-validator-0#comments-listing) ## [PointCross Life Sciences and InterpretOmics partner for Clinical and Genomic Biomarker Management for Drug Development](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-and-interpretomics-partner-for-clinical-and-genomic-biomarker-management-for-drug-development) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 20, 2017, 1:10:41 AM - [Tweet](https://twitter.com/share) [![](https://blog.pointcrosslifesciences.com/hubfs/biomarker2.jpg)](https://blog.pointcrosslifesciences.com/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** [Read More](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-and-interpretomics-partner-for-clinical-and-genomic-biomarker-management-for-drug-development) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-and-interpretomics-partner-for-clinical-and-genomic-biomarker-management-for-drug-development#comments-listing) ## [PointCross Life Sciences’ Clinical Data Repository for SDTM data fills an urgent gap](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-clinical-data-repository-for-sdtm-data-fills-an-urgent-gap) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 20, 2017, 1:10:12 AM - [Tweet](https://twitter.com/share) [![](https://blog.pointcrosslifesciences.com/hubfs/1280px-DNA_methylation.jpg)](https://blog.pointcrosslifesciences.com/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.** [Read More](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-clinical-data-repository-for-sdtm-data-fills-an-urgent-gap) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-clinical-data-repository-for-sdtm-data-fills-an-urgent-gap#comments-listing) ## [PointCross Life Sciences and Xybion forge strategic partnership to deliver SEND services to assure FDA review ready submissions](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-and-xybion-forge-strategic-partnership-to-deliver-send-services-to-assure-fda-review-ready-submissions) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 20, 2017, 1:09:29 AM - [Tweet](https://twitter.com/share) [![](https://blog.pointcrosslifesciences.com/hubfs/SEND.jpg)](https://blog.pointcrosslifesciences.com/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 mandate requiring submission of CDISC SEND datasets starting in December 2016. [Read More](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-and-xybion-forge-strategic-partnership-to-deliver-send-services-to-assure-fda-review-ready-submissions) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-and-xybion-forge-strategic-partnership-to-deliver-send-services-to-assure-fda-review-ready-submissions#comments-listing) ## [PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-to-provide-the-fda-with-nonclinical-study-data-software-and-services) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 20, 2017, 1:09:01 AM - [Tweet](https://twitter.com/share) [![](https://blog.pointcrosslifesciences.com/hubfs/FDA.png)](https://blog.pointcrosslifesciences.com/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** [Read More](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-to-provide-the-fda-with-nonclinical-study-data-software-and-services) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-to-provide-the-fda-with-nonclinical-study-data-software-and-services#comments-listing) ## [PointCross Life Sciences Announces DSIMS™: Drug Safety Information Management Suite](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-announces-dsims-drug-safety-information-management-suite) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 20, 2017, 1:08:30 AM - [Tweet](https://twitter.com/share) [![](https://blog.pointcrosslifesciences.com/hubfs/Big%20Data%20Keyboard%20Crop.jpg)](https://blog.pointcrosslifesciences.com/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 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. [Read More](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-announces-dsims-drug-safety-information-management-suite) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-announces-dsims-drug-safety-information-management-suite#comments-listing) ## [PointCross Life Sciences named to Gartner’s 2013 Cool Vendor List for Life Sciences](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-named-to-gartners-2013-cool-vendor-list-for-life-sciences) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 20, 2017, 1:07:42 AM - [Tweet](https://twitter.com/share) [![](https://blog.pointcrosslifesciences.com/hubfs/1280px-DNA_methylation.jpg)](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-named-to-gartners-2013-cool-vendor-list-for-life-sciences) #### 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. [Read More](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-named-to-gartners-2013-cool-vendor-list-for-life-sciences) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-named-to-gartners-2013-cool-vendor-list-for-life-sciences#comments-listing) ## [PointCross Life Sciences Announces SaaS Environment for FDA Nonclinical Study Data Reviewer Analytics and Submissions](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-announces-saas-environment-for-fda-nonclinical-study-data-reviewer-analytics-and-submissions) Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 20, 2017, 1:07:13 AM - [Tweet](https://twitter.com/share) [![](https://blog.pointcrosslifesciences.com/hubfs/FDA%20Form%20Background%20Image.jpg)](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-announces-saas-environment-for-fda-nonclinical-study-data-reviewer-analytics-and-submissions) #### 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. [Read More](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-announces-saas-environment-for-fda-nonclinical-study-data-reviewer-analytics-and-submissions) 0 Comments [Click here to read/write comments](https://blog.pointcrosslifesciences.com/pointcross-life-sciences-announces-saas-environment-for-fda-nonclinical-study-data-reviewer-analytics-and-submissions#comments-listing) [Next](https://blog.pointcrosslifesciences.com/page/2) ## About ### PointCross Life Sciences blog shared through the lense of industry experts We are excited to bring you a revamped blog at PointCross, where will be frequently sharing blog posts penned by industry leaders on their perspective in the biotechnology and pharmaceutical markets.  ### Subscribe to Email Updates ### Recent Posts Ready to learn more? Stay up-to-date by signing up for our personalized newsletters or scheduling a call with a local team member to better understand your specific needs. [Contact Us](http://www.pointcrosslifesciences.com/index.php/contact/) ## About Us PointCross Life Sciences Inc. delivers proven technology to support drug development through a suite of non-clinical and clinical offerings. ## Solutions - [Clinical Trial & Molecular Biomarker Research](http://www.pointcrosslifesciences.com/index.php/clinical-research-development/) - [Clinical Regulatory Compliance](http://www.pointcrosslifesciences.com/index.php/clinical-regulatory-compliance/) - [Non-Clinical Cross-Study Analytics & Warehousing](http://www.pointcrosslifesciences.com/index.php/non-clinical-cross-study-analytics-warehousing/) - [Non-Clinical Regulatory Compliance](http://www.pointcrosslifesciences.com/index.php/non-clinical-regulatory-compliance/) ## Quick Links - [Resources](http://www.pointcrosslifesciences.com/index.php/all-resources/) - [About Us](http://www.pointcrosslifesciences.com/index.php/about-us/) - [Partners](http://www.pointcrosslifesciences.com/index.php/partners/) - [Careers](http://www.pointcrosslifesciences.com/index.php/careers/) - [Contact](http://www.pointcrosslifesciences.com/index.php/contact/) - [Xbiom](http://www.pointcrosslifesciences.com/index.php/xbiom-platform/) - [MySEND](http://info.pointcrosslifesciences.com/mysend) ## Contact 1291 E. 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