View Webinar Recording: eDataValidator (eDV) for SDTM, ADaM & SEND Click here to sign up for eDataValidator Having trouble viewing the video? Please click here Here is a brief overview of the webinar's key highlights and takeaways. In this webinar, we provided a 30-minute walkthrough of eDV, demonstrating how users can effectively validate their SDTM, ADaM or SEND...
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....
At PHUSE US Connect 2023, PointCross Life Sciences presented a new way to automate the mapping of raw clinical EDC and non-EDC (biomarker) data to SDTM mapping through a Universal Data Model (UDM). Reducing the time to SDTM from weeks to days with built-in traceability, we discussed how SDTM programming and mapping for statistical analysis...
Date: Thursday, January 19, 2023 Time: 09:00am PT / 12:00pm ET
We presented a paper at the PHUSE 2022 Americas Winter Single Day Event on the topic of Universal Data Model (UDM) being leveraged to streamline pathways to SDTM and ADaM Standards. This paper introduces Xbiom to automatically map raw data to SDTMs. SDTM Automation By Reusability and Repeatability Leverage a Universal Data Model (UDM) to Streamline...
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...
Webinar Recording May 2021
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...
A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning | 17th, February 2021