On February 28th, 2023, PMDA released a new validation rule version 4.0 for SDTM (Study Data Tabulation Model) and Define.XML. A major change in PMDA Validator Rules v4.0 is the support of SDTM IG v3.3, as well as the removal of support of Define.xml 1.0 PointCross Life Sciences has incorporated the updated rulesets on April 28th, 2023....
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 sponsor Clinical...
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 (Â Technical Rejection Criteria for Study Data) The TRC has been added to the existing eCTD validation criteria to enforce compliance with the SEND requirements for study types modelled in an FDA supported SEND Implementation Guide (SENDIG) version. Any electronic submission submitted after Sept 15th,...
Effective March 15, 2021: Support for SEND DART IG 1.1 per FDA Data Standards Catalog (Â FDA Announcement;Â FDA Data Standards Catalog) Our Software solution (Xbiom) and services are set up to accommodate DART IG 1.1, and we have been generating SEND datasets for DART studies including EFD, Fertility and Early Embryonic Development and Pre-Natal and Post Natal...
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...
Xbiom™ 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...