Upcoming Conference & Events :
Previous Conferences & Events :
Bay Area Biotech-Pharma Statistics Workshop (BBSW)
Date: October 24-25, 2024
Location: Crowne Plaza Hotel in Foster City, CA
We’re excited to announce that PointCross has sponsored the Bay Area Biostatistics & Bioinformatics Symposium (BBSW) 2024 that took place on October 24-25, 2024, at the Crowne Plaza Hotel in Foster City, CA.
This year’s symposium brought together brilliant minds to explore the future of biostatistics and bioinformatics, with keynote speakers:
- Dr. Gregory Alexander from the FDA
- Dr. Robert Tibshirani from Stanford University
Learn more: Program and Registration — BBSW
SCDM Annual Conference 2024
Date: September 29 – October 2, 2024
Location: Boston, Massachusetts, USA
PointCross attended the SCDM Annual Conference 2024 in Boston from September 29 to October 2.
Learn more: Annual Conference 2024 – SCDMLive
Unlocking Insights: Cross-Study Analysis of SEND Datasets with Xbiom
Webinar
Date: Wednesday, September 25th, 2024
Time: 09:00 AM PT / 12:00 PM ET
Visualization of SEND datasets
Webinar
July 31, 2024
View Recording
Click here for more information
PHUSE SDE
Gurugram, India
March 16th, 2024
The discussions revolving around “Data Standards, Metadata, Automation, and Technology” were incredibly enlightening, underscoring the significance of leveraging data strategically for unlocking business value.
SCOPE Summit for Clinical Ops Executives 2024
Date: February 11-14, 2024
Rosen Shingle Creek Orlando, FL
PointCross will be at SCOPE Summit for Clinical Ops Executives 2024 in Orlando, FL, from February 11-14. Our Vice President Rahul Madhavan (Strategic Programs) and Vice President Harinarayan Gopichandran (Technical Solutions) look forward to meeting our customers on site and forming new relationships with those interested in modernizing their clinical data flow. Join us for the premier industry event for Clinical Operations Professionals, bringing together industry leaders and innovators to advance clinical trial excellence and patient care.
Learn more: SCOPE Summit 2024
PHUSE SDE 2023
Date: Thursday 10 August 2023
Foster City, CA 94404
View Event Presentations:
Automated SDTM Generation using a Single Point of Truth
Better CDISC Standards with Metadata Programming
eDataValidator Webinar
Webinar Date & Time for US users:
Date: Wednesday, May 24th
Time: 9:00 AM PT / 12:00 PM ET
Society of Toxicology 2023
Nashville, Tennessee
March 19-23
Booth #1429
Webinar : Harmonizing Raw Data with CDISC Standards to Streamline SDTMs
Date: Thursday, January 19, 2023
Time: 09:00am PT / 12:00pm ET
View Recording
PhUSE Americas Winter SDE
Cary, North Carolina
December 1, 2022
PointCross Life Sciences 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
Society of Toxicology 2022
San Diego, California
More info on Interim Study Monitoring can be found here.
Analyzable Data is Submittable Data: Interim or Final SEND (Webinar)
October 19th 2021
View Recording
View Q&A sheet
PhUSE US Connect-2021
June 2021
Poster Presentation: Integrating Clinical Data for Translational Research
Click here to view poster
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 Development studies. We also have worked with multigeneration reprotoxic studies in the past. To learn more about our SEND conversion services, contact us at dsservices@pointcross.com.
Webinar Recording: 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.
Listen now
Click here to View Abstract
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, 2021 will be rejected if the submitted datasets don’t pass the same. Our PointCross Validation engine have already been extended to ensure that all datasets are checked against the Technical Rejection Criteria. You can verify your datasets and make sure that they do pass the TRC by using our eDataValidator.
Molecular Medicine Tri-Con
PHUSE CSS 2020
Presentation Title:
PHUSE US CSS 2020 PP08 : Taking full advantage of the SEND data potential
Jointly published by Roche and PointCross Lifesciences
Click here to listen Virtual CSS
Conference: PhUSE SDE – Canton, MI
Tuesday 29 September 2020
Presentation Title: Value of Rapid Integration of Patient Immunoassays and eCRFs in Trials
PhUSE CSS 2020 Poster
PhUSE CSS 2020 September 21 – 23, 2020
“A Process for Automated Reconciliation of SEND Datasets with Study Reports for Confident Submission and Review.”
PointCross presented and was awarded Best Poster In the Industry category for our poster. Click the link below to view the poster.
PhUSE CSS final poster
Laura Kaufman certificate PhUSE CSS
PHUSE US Connect 2020
(Conference cancelled, but presentations are available on PhUSE website)
Presentation Title: DH12: Validation Consistency and Conformance Checking of SEND Datasets
Webinar: Additional Tools and QC checks to ensure SEND datasets are Fit For Review (FRR).
The recording of the webinar is available here. During the webinar, you will learn about an affordable way of meeting these new FFR recommendations by building on the automated checks, reconciliation tools, and processes that we presented during the March 17th webinar.
Webinar – The release of the PointCross eDataValidator
Thursday January 16th 2020 at 10:00 am ET
The webinar will show you how to access the eDataValidator from the AWS Marketplace and answer any questions you may have.
PhUSE EU Connect: Amsterdam
November 10 -13, 2019
Live demo of our offerings or learning more about the release of our eDataValidator.
PhUSE Single day event: Beerse, Belgium
September 11, 2019 | Roche-PointCross Joint Presentation
Presentation on “Review Safety Signals from Interim or Submittable SEND Datasets Using MySEND” by Nicolas Philippe, PointCross Life Sciences and Dr. Dragomir Ivanov Draganov, Roche
Visit Here..
Smart Transformation of Disparate Biopharma Source Data to Unified Machine Readable Target Data Models
June 20, 2019
Download Whitepaper
15th annual biomarker world congress
June 17-20
Booth #114
Seaport World Trade Center, Boston, MA
Webinar: Smart Transformation Of Your Disparate Data Into Unified Form For Repurposing
Thursday, June 13th at 8:00am PT/ 11:0am ET.
Topics:
- Standards Management
- Ontology Management
- eData Validation
- Mapping of disparate data sources in their native models to a standard model
- Run time mapping to generate curate datasets for purpose
PhUSE CSS in Silver Spring, MD
June 9-11, 2019
Booth #9
Silver Spring Civic Center, Silver Spring, MD
https://www.phuse.eu/css19
PointCross and AWS Workshop: A Workbench for Biomarker and Translational Research
AWS and PointCross Workshop at Boston
April 17th, 2019 from 8:00 am – 9:30am ET.
Bio-IT World Conference an Expo – 2019
Bio-IT World Conference an Expo – 2019
Booth #638
April 15-18, 2019
Phuse SDE
Agile Statistical Computing environment for Clinical Development
April 4, 2019 | Foster City, California
CDISC SEND Face to Face at FDA
April 1-5, 2019
Visit Here
PhUSE US Connect
Presentation Title: ML11: Smart Transformation of Clinical & Nonclinical Data for Insights
February 24th–27th | Baltimore
Bayer Data Insights Event
Feb 21, 2019 | 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 sources under FAIR principles. A number of exciting internal ventures that pursued insights from research and developmental data were presented at the open house. PointCross was invited to attend this special event.