The
XBIOM™ PLATFORM
XBIOM™ NONCLINICAL INSIGHTS
Longitudinal integration of disparate components of nonclinical studies into a repository for search and discovery of signals or cohorts based on specified criteria.
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XBIOM™ CLINICAL INSIGHTS
Clinical trial repository with longitudinally integrated biomarker assay data for analytics and visualization of ongoing or completed trials.
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XBIOM™ REGULATORY
Regulatory workflows and tools for the gathering, preparation, validation, and packaging of submissions to regulatory agencies.
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XBIOM™ SMART TRANSFORMATION
Rapidly map legacy and raw data to universal data model, regulatory, industry, or de-facto standards.
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News & Announcements
Webinar : Harmonizing Raw Data with CDISC Standards to Streamline SDTMs
Date: Thursday, January 19, 2023
Time: 09:00am PT / 12:00pm ET
View Webinar Recording:
Harmonizing Raw Data with CDISC Standards to Streamline SDTMs
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.).
PhUSE Americas Winter SDE
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:
Universal Data Model (UDM) for a Streamlined Pathway to SDTM and ADaM Standards
eDataValidator
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
Full press release can be found here
To get started with eDataValidator, please proceed here.
Society of Toxicology
Date and Time: March 29th at 1:30pm PT
Room: 23A
San Diego, CA.
PointCross held a panel discussion with senior industry partners at the Society of Toxicology conference in March 2022 discussing the implications of interim study monitoring, including the time and cost savings achievable by having a subject’s in-life, necropsy, and pathology findings available in digital format sooner than the final study report.
More information on Interim Study Monitoring can be found here
Live Webinar:
Analyzable Data is Submittable Data: Interim or Final SEND
Poster Presentation :
Integrating Clinical Data for Translational Research
Enabling Data Integration for Translational & Precision Medicine
May 2021
PointCross’s Xbiom Clinical Insights Module is designed for Translational Medicine Teams to curate, harmonize, and standardize disparate assay data and EDC study data from clinical trials, along with genotyping data, molecular, and other biomarker data. Our newly launched Data Concierge Service helps shoulder the burden of data wrangling by integrating directly with your CROs and external labs to help close the gap between these disparate data sources and rendering study data fit-for-use by scientists and researchers for longitudinal analysis, cross-domain search, and stratified cohort selection based on patient history, consent availability, specific molecular biomarkers, study type, and more.
Driving
Success For Our Valued Customers
We thank our customers for their trust shown in us and take pride in our accomplishments.
US – India – Europe
Our Vision
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.
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