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
2023 SOT - Society Of Toxicology
Date: March 19 – 23, 2023
in Nashville, TN
Booth #1429
We are Exhibiting !
FDA’s CBER SEND requirement goes into effect on March 15th. Stop by PointCross Booth #1429 and meet our SEND leadership team and Sr. Toxicologist. We’ll be on hand (with chocolates) to help answer any questions you have on generating 100% submission ready SEND datasets. See you there!
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.
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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