--- title: PointCross announces SEND-ASSURE for Data Consistency in Submissions to the FDA description: SEND-ASSURE is an audit solution to reduce risks in Regulatory e-Data Submissions image: https://blog.pointcrosslifesciences.com/hubfs/FDA-1.png --- [![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 # PointCross announces SEND-ASSURE for Data Consistency in Submissions to the FDA Posted by [PointCross Life Sciences](https://blog.pointcrosslifesciences.com/author/pointcross-life-sciences) on Jan 20, 2017, 1:05:54 AM ![](https://blog.pointcrosslifesciences.com/hubfs/PCLSlogo.png) Find me on: [LinkedIn](https://www.linkedin.com/company/pointcross) [Twitter](https://twitter.com/PointCross_LS) - [Tweet](https://twitter.com/share) *SEND-ASSURE is an audit solution to reduce risks in Regulatory e-Data Submissions* Silver Spring, MD, March 9, 2015/ PRNewswire PointCross Life Sciences today announced the launch of its SEND-ASSURE audit solution to help pharmaceutical companies avoid the consequences of submitting standardized nonclinical data that is inconsistent with their study reports. CDISC SEND standardized data is required for NDA, BLA and IND submissions to the FDA starting in 2016.  Data consistency and quality issues in standardized data will cause delays in regulatory review by the FDA, or even result in a refusal to file.  This in turn can delay time-to-market of important drug products. SEND-ASSURE is offered directly from PointCross Life Sciences initially and soon with a major Cloud partner.  Sponsors and their CROs are also provided views of their SEND data using the same PointCross [DSIMS™](http://www.pointcrosslifesciences.com/solutions/dsims.asp) product deployed as NIMS at the FDA. Highlighting the importance of this new offering, Kristi Johnson, SEND Data Services Manager, PointCross Life Sciences said, “If you are a Pharmaceutical company, you really cannot afford delays in the regulatory review process because of avoidable issues with your SEND data.  Our experts who support the FDA’s JumpStart Nonclinical Service are experienced in identifying these issues from actual submissions. By offering this solution to the industry, we hope that submitted data will achieve a high degree of consistency to improve the review process“. #### About PointCross Life Sciences [PointCross Life Sciences](http://www.pointcrosslifesciences.com/) provides the life sciences industry with data management, analytics and visualization solutions that reduce risks, improve data quality, shorten time to market, and generate better insights from R&D and regulatory data.  The SEND offerings we provide include [DSIMS](http://www.pointcrosslifesciences.com/solutions/dsims.asp), our commercial review product deployed as NIMS at the FDA, and the related [SEND-ASSURE](http://www.pointcrosslifesciences.com/services/SEND-ASSURE.asp) and [Data Standardization](http://www.pointcrosslifesciences.com/services/DataStandardization.asp) solutions. We are a registered CDISC solution provider and collaborate with consortia like PhUSE.  PointCross was recognized in 2013 as one of [Gartner’s Cool Vendors in Life Sciences](https://www.gartner.com/doc/2470915/cool-vendors-life-sciences-). #### Contact Ryan Brown, Senior Vice President PointCross Life Sciences, Inc. 1291 E. Hillsdale Blvd., Suite 304 Foster City, CA 94404 ryan.brown@pointcross.com ## 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. 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