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 SDE 2023

DateThursday 10 August 2023
Foster City, CA 94404
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Progress Towards CDISC 360 Mission with CDISC Standards, Metadata Design, SDTM/ADaM Automation and Compliance   

View Event Presentations:

Automated SDTM Generation using a Single Point of Truth

Better CDISC Standards with Metadata Programming

eDataValidator Webinar

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.

Learn more: eDataValidator for SDTM, ADaM & SEND – PointCross Life Sciences

2023 SOT - Society Of Toxicology

Date: March 19 – 23, 2023
Nashville, TN

We had three SEND-filled days of discussion with all those who attended #ToxExpo at Society of Toxicology (SOT) 2023 meeting in Nashville. Sponsors and CROs can now use our SEND quote generator to receive an instant price quote, without exchanging any confidential study information.

PHUSE US Connect

Renaissance Orlando
Date: March 05 – 08, 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:

EDC Raw Data to SDTM Curation, Mapping and Automation with the Xbiom Tool

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.

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10+ Years Experience in Life Science

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