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...
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 ( 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...
A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning | 17th, February 2021
A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning | 17th, February 2021
Value of Rapid Integration of Patient Immunoassays and eCRFs in Trials | Tuesday 29 September 2020
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.
Jointly published by Roche and PointCross Lifesciences
PointCross will be holding a joint presentation with Roche | 9th–13th November
DH12: Validation Consistency and Conformance Checking of SEND Datasets