Conferences and Events

Past conferences :

Effective March 15, 2021: Support for SEND DART IG 1.1 per FDA Data Standards Catalog

FDA AnnouncementFDA 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


Sep 15 2021
September 15, 2021

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.


Sep 21 2020
September 21, 2020

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


Sep 20 2020
September 20, 2020

PHUSE US Connect 2020

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