PointCross Blog

Clinical and Nonclinical validation Tools

When it comes to clinical and nonclinical study submission datasets to the FDA or PMDA, there are multiple validation tools available. This article will talk about eDataValidator (eDV) from PointCross Life Sciences, which offers a strong and complete validation tools for both clinical and nonclinical studies. The eDataValidator is a single solution for IND, NDA, and BLA...

FDA SEND Dataset Services

The U.S. Food and Drug Administration (FDA) requires SEND (Standard for Exchange of Nonclinical Data) as a standard for nonclinical study data submission to the Center for Drug Evaluation and Research (CDER). SEND is a data standard mandate of CDISC SDTM standard for nonclinical studies and provides a framework to collect and present individual animal study...

SDTM – Everything that you need to know

What is SDTM?SDTM (Study Data Tabulation Model) is one of the requirements for data submission to the FDA (U.S) and PMDA (Japan). To facilitate data collection, management, analysis, and reporting procedures, SDTM offers a standard for organizing and presenting data. Implementing SDTM helps with data warehousing and aggregation, encourages mining and reuse, makes sharing easier, supports due diligence...

PointCross announces full complement release of eDataValidator

July 20 2022 – PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing demand from...

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 Announces DSIMS™: Drug Safety Information Management Suite

PointCross Life Sciences Announces DSIMS™: Drug Safety Information Management SuiteFOSTER 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 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 selectionFoster 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, 2016PointCross 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...

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...