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

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

Webinar Recording

Tuesday, October 19th, 2021

Live Webinar:

Analyzable Data is Submittable Data: Interim or Final SEND

PhUSE US Connect

June 2021

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.

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