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Benchmark your SEND Readiness

Posted by PointCross Life Sciences on Jan 29, 2018 10:53:46 AM

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.
 
Download Whitepaper "Benchmark SEND Readiness"
 
 
 
 
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Topics: Insider, life sciences, pharma, biotech, software, SEND

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

Posted by PointCross Life Sciences on Feb 15, 2017 2:51:54 PM

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.

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Introducing the PointCross Desktop Validator

Posted by PointCross Life Sciences on Jan 19, 2017 2:59:04 PM

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.

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

Posted by PointCross Life Sciences on Jan 19, 2017 2:40:41 PM

RDIS™ and iOmics™ integration arcs across nonclinical, clinical and genomic biomarkers for targeted therapeutic drug development and stratified patient selection

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

Posted by PointCross Life Sciences on Jan 19, 2017 2:40:12 PM

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.

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

Posted by PointCross Life Sciences on Jan 19, 2017 2:39:29 PM

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.

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

Posted by PointCross Life Sciences on Jan 19, 2017 2:39:01 PM

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

FOSTER CITY, Calif., Oct. 3, 2011 PRNewswire

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

Posted by PointCross Life Sciences on Jan 19, 2017 2:38:30 PM

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.

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PointCross Life Sciences named to Gartner’s 2013 Cool Vendor List for Life Sciences

Posted by PointCross Life Sciences on Jan 19, 2017 2:37:42 PM

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.

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

Posted by PointCross Life Sciences on Jan 19, 2017 2:37:13 PM

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.

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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. 

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