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 Development studies. We also have worked with multigeneration reprotoxic studies in the past. To learn more about our SEND conversion services, contact us at email@example.com.
Past conferences :
PointCross’s Xbiom Clinical Insights Module is designed for Translational Medicine Teams to curate, harmonize, and standardize disparate assay data and EDC study data from clinical trials, along with genotyping data, molecular, and other biomarker data. Our newly launched Data Concierge Service helps shoulder the burden of data wrangling by integrating directly with your CROs and external labs to help close the gap between these disparate data sources and rendering study data fit-for-use by scientists and researchers for longitudinal analysis, cross-domain search, and stratified cohort selection based on patient history, consent availability, specific molecular biomarkers, study type, and more.
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, 2021 will be rejected if the submitted datasets don’t pass the same. Our PointCross Validation engine have already been extended to ensure that all datasets are checked against the Technical Rejection Criteria. You can verify your datasets and make sure that they do pass the TRC by using our eDataValidator.
Tuesday 29 September 2020
Presentation Title: Value of Rapid Integration of Patient Immunoassays and eCRFs in Trials
PhUSE CSS 2020 September 21 – 23, 2020
“A Process for Automated Reconciliation of SEND Datasets with Study Reports for Confident Submission and Review.”
PointCross presented and was awarded Best Poster In the Industry category for our poster. Click the link below to view the poster.
(Conference cancelled, but presentations are available on PhUSE website)
Presentation Title: DH12: Validation Consistency and Conformance Checking of SEND Datasets