Enabling Data Integration for Translational & Precision Medicine
Webinar Recording May 2021
PointCross Testing
Beginning on September 15, 2021, FDA will begin enforcing the Technical Rejection Criteria (TRC).
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,...
SEND DART is now supported by PointCross Life Sciences
Support for SEND DART IG 1.1 as per FDA Data Standards Catalog 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...
Tri-Con of Molecular Medicine
A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning | 17th, February 2021
Validation Consistency and Conformance of SEND Datasets
DH12: Validation Consistency and Conformance Checking of SEND Datasets
PhUSE EU Connect: Amsterdam
November 10 -13 | A live demo of our offerings or learning more about the release of our eDataValidator.
Xbiom Workbench and Insights
Data Hub for Clinical, Translational and Biomarker Research- View Video
Xbiom Smart Transformer – Demo
Rapidly map legacy and raw data to CDISC standards - View Video
Xbiom Accelerating Innovation in BioPharma
Whitepaper
Unified Machine Readable Target Data Models from Smart Transformer of Disparate Biopharma Source Data
Whitepaper - June 20, 2019