SRR Files & Template
SRR (Study Report Reference) files are machine readable columnar formatted files generated using Study Report. SRR files is a valuable resource for software companies to compare and reconcile the summary tables data in the Study Report with the same summaries re-generated from the SEND datasets, which helps the data consistency check of SEND files. Please...
Case Study: Integrated Repository of Nonclinical Studies
Integrated Repository of Nonclinical Studies: A Case Study for a Centralized, Searchable Registry of all Nonclinical Studies for Drug Safety and Toxicology Research In this case study we describe how a major Biopharma ranked in the top three, uses Xbiom Nonclinical as a centralized, shared searchable repository of all ongoing, current and legacy studies across...
Enabling Data Integration for Translational & Precision Medicine
Webinar Recording May 2021
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...
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,...
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
Conference: PhUSE SDE – Canton, MI
Value of Rapid Integration of Patient Immunoassays and eCRFs in Trials | Tuesday 29 September 2020
PhUSE CSS 2020 Poster
PointCross presented and was awarded Best Poster In the Industry category for our poster, A Process for Automated Reconciliation of SEND Datasets with Study Reports for Confident Submission and Review.
Taking full advantage of the SEND data potential
Jointly published by Roche and PointCross Lifesciences
Visualization of “Real Time” Data from Ongoing Non-Clinical Studies in Support of Study Monitoring and informed Decision Making
PointCross will be holding a joint presentation with Roche | 9th–13th November
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
SEND Dataset FRR Webinar: Tools & QC Checks
June 8th, 2020
100% Consistency Check of SEND Datasets Against NCSR
March 17th, 2020
PhUSE Single day event
Beerse, Belgium | September 11, 2019