Analyzable Data is Submittable Data: Interim or Final SEND (Webinar)
October 19th 2021
PhUSE US Connect-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 firstname.lastname@example.org.
Webinar Recording: Enabling Data Integration for Translational & Precision Medicine
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.
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
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).
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
Smart Transformation of Disparate Biopharma Source Data to Unified Machine Readable Target Data Models
June 20, 2019
Webinar: Smart Transformation Of Your Disparate Data Into Unified Form For Repurposing
Thursday, June 13th at 8:00am PT/ 11:0am ET.
- 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
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
April 15-18, 2019
Agile Statistical Computing environment for Clinical Development
April 4, 2019 | Foster City, California
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.