All Clinical Resources including webinars, conferences, white papers / demos, news related to the clinical industry can be found here.
PhUSE Americas Winter SDEpointCrossAdmin
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...
Smart Transformation of Clinical & Nonclinical Data for InsightspointCrossAdmin
PhUSE US Connect - February 2019
Xbiom – A Biomarker Research Workbench for BioTechs and BioPharmapointCrossAdmin
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 AlgorithmspointCrossAdmin
PhUSE paper- Ensuring consistency of SEND Datasets with Study Reports using Machine Learning Algorithms
PhUSE CSS March Poster Ensuring consistency of SEND DatasetspointCrossAdmin
PhUSE CSS March Poster_Ensuring consistency of SEND Datasets with Study Reports using Machine Learning Algorithms
Standards and Ontology Driven Workflow Automation of Clinical StudiespointCrossAdmin
Standards and Ontology Driven Workflow Automation of Clinical Studies - PointCross Life Sciences
Xbiom™ for Molecular Biomarker Research in Precision MedicinepointCrossAdmin
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...
Webinar on Harmonizing Raw Data with CDISC Standards to Streamline SDTMspointCrossAdmin
Date: Thursday, January 19, 2023 Time: 09:00am PT / 12:00pm ET
Enabling Data Integration for Translational & Precision MedicinepointCrossAdmin
Webinar Recording May 2021
Data Hub for Clinical, Translational and Biomarker Research- View Video
Xbiom Smart Transformation-demopointCrossAdmin
Rapidly map legacy and raw data to CDISC standards - View Video
How to Integrate Clinical, Biomarker, and Other Disparate Data SourcespointCrossAdmin
Title: How to Integrate Clinical, Biomarker, and Other Disparate Data Sources May 16, 2017
EDC Raw Data to SDTM Curation, Mapping and Automation with the Xbiom ToolpointCrossAdmin
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 MedicinepointCrossAdmin
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 DatasetspointCrossAdmin
DH12: Validation Consistency and Conformance Checking of SEND Datasets
PhUSE EU Connect: AmsterdampointCrossAdmin
November 10 -13 | A live demo of our offerings or learning more about the release of our eDataValidator.
PhUSE 2019 Computational Science SymposiumpointCrossAdmin
Booth #9, Silver Spring Civic Center June 9-11, 2019 | Silver Spring, MD
Bayer Data Insights Event BerlinpointCrossAdmin
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 ...
AWS and PointCross Workshop at BostonpointCrossAdmin
April 17, 2019 | 8:00 am – 9:30am ET | Boston, MA 02210
PhUSE Connect EU – The Clinical Data Science ConferencepointCrossAdmin
November 4 – 8, 2018 | KAP Europa | Frankfurt, Germany
The Molecular Medicine Tri Con Conference 2018pointCrossAdmin
Feb 11 – 16, 2018 | San Francisco, CA | Booth # 732
PhuSE Single Day Event Foster CitypointCrossAdmin
Feb 22, 2018 | Foster City Community Center | Wind Room
PointCross releases eDataValidator for SDTM, ADaM, SEND, and Define.XML conformance to prevailing FDA, CDISC, and PMDA rulespointCrossAdmin
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).pointCrossAdmin
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 CatalogpointCrossAdmin
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...
PointCross Life Sciences’ Clinical Data Repository for SDTM data fills an urgent gappointCrossAdmin
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 Life Sciences and InterpretOmics partner for Clinical and Genomic Biomarker Management for Drug DevelopmentpointCrossAdmin
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...