Enabling Data Integration for Translational & Precision Medicine
Webinar Recording May 2021
FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021
pointCrossAdmin2021-06-16T15:16:32+00:00FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 (Â 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
pointCrossAdmin2021-06-16T15:15:21+00:00Effective March 15, 2021: Support for SEND DART IG 1.1 per FDA Data Standards Catalog (Â FDA Announcement;Â 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
pointCrossAdmin2021-06-16T14:51:01+00:00FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 (Â 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
pointCrossAdmin2021-06-16T14:51:49+00:00Effective March 15, 2021: Support for SEND DART IG 1.1 per FDA Data Standards Catalog (Â FDA Announcement;Â 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
pointCrossAdmin2021-08-25T09:34:03+00:00A Universal Data Model for Longitudinal Integration of Disparate Biomarker and In-Life Patient Data Augmented by Machine Learning | 17th, February 2021
Molecular Medicine Tri-Con
pointCrossAdmin2021-08-05T13:43:05+00:00A 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
pointCrossAdmin2021-08-18T13:51:50+00:00Value of Rapid Integration of Patient Immunoassays and eCRFs in Trials | Tuesday 29 September 2020
PhUSE CSS 2020 Poster
pointCrossAdmin2021-08-25T09:40:07+00:00PointCross 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.
PHUSE US CSS 2020 PP08 : Taking full advantage of the SEND data potential
pointCrossAdmin2021-08-05T14:54:38+00:00Jointly published by Roche and PointCross Lifesciences