All Clinical Resources including webinars, conferences, white papers / demos, news related to the clinical industry can be found here.
Universal Data Model – PhUSE Americas Winter SDE
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. SDTM Automation By Reusability and Repeatability Leverage a Universal Data Model (UDM) to Streamline...
Unified Machine Readable Target Data Models from Smart Transformation of Disparate Biopharma Source Data
Whitepaper - June 20, 2019
Xbiom – A Workbench for Translational and Biomarker Research
2 Page Brochure
Smart Transformation of Clinical & Nonclinical Data for Insights
PhUSE US Connect - February 2019
Xbiom – A Biomarker Research Workbench for BioTechs and BioPharma
This draft white paper from PointCross Life Sciences Inc. (Foster City, CA) presents the opportunities for biomarker and biologics based therapeutic development using search analytics and data integration of clinical and biomarker data as available in its Xbiom solution
PhUSE paper- Ensuring consistency of SEND Datasets with Study Reports using Machine Learning Algorithms
PhUSE paper- Ensuring consistency of SEND Datasets with Study Reports using Machine Learning Algorithms
PhUSE CSS March Poster Ensuring consistency of SEND Datasets
PhUSE CSS March Poster_Ensuring consistency of SEND Datasets with Study Reports using Machine Learning Algorithms
Standards and Ontology Driven Workflow Automation of Clinical Studies
Standards and Ontology Driven Workflow Automation of Clinical Studies - PointCross Life Sciences
Xbiom™ for Molecular Biomarker Research in Precision Medicine
There is a perfect storm brewing where advances in genomic screening, identifying molecular biomarkers and precisely targeted medicines and diagnostics, smart monitoring of patient vitals and physiology using devices such as smart phones and...
eDataValidator for SDTM, ADaM & SEND
View Webinar Recording: eDataValidator (eDV) for SDTM, ADaM & SENDClick here to sign up for eDataValidatorHaving trouble viewing the video? Please click hereHere is a brief overview of the webinar's key highlights and takeaways. In this webinar, we provided a 30-minute walkthrough of eDV, demonstrating how users can effectively validate their SDTM, ADaM or SEND...
Webinar on Harmonizing Raw Data with CDISC Standards to Streamline SDTMs
Date: Thursday, January 19, 2023 Time: 09:00am PT / 12:00pm ET
Enabling Data Integration for Translational & Precision Medicine
Webinar Recording May 2021
Xbiom Workbench and Insights
Data Hub for Clinical, Translational and Biomarker Research- View Video
Xbiom Smart Transformation – Demo
Rapidly map legacy and raw data to CDISC standards - View Video
How to Integrate Clinical, Biomarker, and Other Disparate Data Sources
Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
PHUSE SDE 2023
Progress Towards CDISC 360 Mission with CDISC Standards, Metadata Design, SDTM/ADaM Automation and Compliance Date: Thursday 10 August 2023Location: Wind Room, Foster City Community Center, 1000 E Hillsdale Blvd, Foster City, CA 94404Registration Link: PHUSE SDE 2023 (phuse-events.org) Director & the SDE Chairs: PHUSE SDE 2023 Director & the SDE ChairsPHUSE August Single Day Event (SDE) on...
EDC Raw Data to SDTM Curation, Mapping and Automation with the Xbiom Tool
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...
Tri-Con of Molecular Medicine
A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning | 17th, February 2021
PHUSE US Connect 2020 -DH12: Validation Consistency and Conformance Checking of SEND Datasets
DH12: Validation Consistency and Conformance Checking of SEND Datasets
PhUSE EU Connect: Amsterdam
November 10 -13 | A live demo of our offerings or learning more about the release of our eDataValidator.
PhUSE Single day event
Beerse, Belgium | September 11, 2019
PhUSE 2019 Computational Science Symposium
Booth #9, Silver Spring Civic Center June 9-11, 2019 | Silver Spring, MD
Bayer Data Insights Event Berlin
Bayer held an internal “invitee only” day to discuss, celebrate, and share the possibilities and use cases of PORTIN – a portal for translational data integration. PORTIN is built on PointCross Xbiom with integration to various enterprise data ...
Bio-IT World Conference an Expo – 2019
Booth #638 | April 15-18, 2019 | Boston, MA
Workshop: A Workbench for Biomarker and Translational Research
April 17, 2019 | 8:00 am – 9:30am ET | Boston, MA 02210
Phuse SDE
April 4, 2019 | Foster City, California
PhUSE Connect EU – The Clinical Data Science Conference
November 4 – 8, 2018 | KAP Europa | Frankfurt, Germany
The Molecular Medicine Tri Con Conference 2018
Feb 11 – 16, 2018 | San Francisco, CA | Booth # 732
PhuSE Single Day Event Foster City
Feb 22, 2018 | Foster City Community Center | Wind Room
PhUSE CSS Computational Science Symposium
March 4 – 6, 2018 | Silver Spring, MD
PointCross Incorporates PMDA Validation Rules V4
On February 28th, 2023, PMDA released a new validation rule version 4.0 for SDTM (Study Data Tabulation Model) and Define.XML. A major change in PMDA Validator Rules v4.0 is the support of SDTM IG v3.3, as well as the removal of support of Define.xml 1.0PointCross Life Sciences has incorporated the updated rulesets on April 28th, 2023....
PointCross releases eDataValidator for SDTM, ADaM, SEND, and Define.XML conformance to prevailing FDA, CDISC, and PMDA rules
PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing demand from sponsor Clinical...
Beginning on September 15, 2021, FDA will begin enforcing the Technical Rejection Criteria (TRC).
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 ( Technical Rejection Criteria for Study Data) The TRC has been added to the existing eCTD validation criteria to enforce compliance with the SEND requirements for study types modelled in an FDA supported SEND Implementation Guide (SENDIG) version. Any electronic submission submitted after Sept 15th,...
Effective from March 15, 2021: Support for SEND DART IG 1.1 as per FDA Data Standards Catalog
Effective March 15, 2021: Support for SEND DART IG 1.1 per FDA Data Standards Catalog ( FDA Announcement; FDA Data Standards Catalog) Our Software solution (Xbiom) and services are set up to accommodate DART IG 1.1, and we have been generating SEND datasets for DART studies including EFD, Fertility and Early Embryonic Development and Pre-Natal and Post Natal...
Clinical Data Repository for SDTM data fills an urgent gap
CIMS™, the PointCross Life Science built Repository for Clinical SDTM Data is now available to Pharma sponsors with compliant standardized NDA submissions to FDA guidance. Silver Spring, MD, March 14, 2016 PointCross Life Sciences today announced its formal release of CIMS™, a Hadoop (HDFS) based extensible repository. CIMS has extensive workflows and validations systems built-in for...
PointCross and InterpretOmics partner for Clinical and Genomic Biomarker Management for Drug Development
Xbiom™ and iOmics™ integration arcs across nonclinical, clinical and genomic biomarkers for targeted therapeutic drug development and stratified patient selection Foster City, CA, April 20, 2015 /PRNewswire/ — PointCross Life Sciences today announced a strategic partnership with InterpretOmics Pvt. Ltd. to provide an integrated Big Data and globally accessible environment for genomic interpretation and analysis...