Conferences and Events

( 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.

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

( 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.

Feb 17th 2021
Poster: A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning
Click here to View Abstract

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

Tuesday 29 September 2020
Presentation Title: Value of Rapid Integration of Patient Immunoassays and eCRFs in Trials

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

(Conference cancelled, but presentations are available on PhUSE website)
Presentation Title: DH12: Validation Consistency and Conformance Checking of SEND Datasets

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.