News & Announcements
Progress Towards CDISC 360 Mission with CDISC Standards, Metadata Design, SDTM/ADaM Automation and Compliance
View Event Presentations:
Date: May 23 & 24, 2023
In this webinar, you will learn the steps to validate your dataset by selecting the necessary validation rules for submission to regulatory authorities such as FDA and PMDA.
2023 SOT - Society Of Toxicology
Date: March 19 – 23, 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 outputs has traditionally been labor and code intensive.
Read more here:
Date: Thursday, January 19, 2023
Time: 09:00am PT / 12:00pm ET
View Webinar Recording:
In this webinar, we introduce a new, automated mapping of raw clinical EDC and biomarker data to SDTM mapping through the Universal Data Model which standardizes all raw and CDISC metadata (files, variables, data, etc.).
Cary, North Carolina
December 1, 2022
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.
To read the paper, please click on the link below:
Date : July 20th 2022
PointCross Life Sciences announced the full complement release of its eDataValidator (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. eDV offers limitless validation of Clinical SDTM as well as Nonclinical SEND, making this a single solution for IND, NDA and BLA preparation
To get started with eDataValidator, please proceed here.
Success For Our Valued Customers
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US – India – Europe
Our Vision is to standardize and contextually integrate all data collected in discovery or nonclinical and clinical trials, with genomic and immune response data from the patient from their bio-samples or other, to support precision medicine development and translational research to discover treatments for illness and disease.