Enabling Data Integration for Translational & Precision Medicine
Webinar Recording May 2021
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 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,...
Effective March 15, 2021: Support for SEND DART IG 1.1 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 EFD, Fertility and Early Embryonic Development and Pre-Natal and Post Natal...
Molecular Medicine Tri-Con
A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning | 17th, February 2021
PHUSE US Connect 2020 -DH12: Validation Consistency and Conformance Checking 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
Data Hub for Clinical, Translational and Biomarker Research- View Video
Xbiom Smart Transformation
Rapidly map legacy and raw data to CDISC standards - View Video
Smart Transformation Of Your Disparate Data Into Unified Form For Repurposing
Thursday, June 13 at 8:00am PT/ 11:0am ET
Xbiom Accelerating Innovation in BioPharma
Whitepaper