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 Development studies. We also have worked with multigeneration reprotoxic studies in the past. To learn more about our SEND conversion services, contact us at firstname.lastname@example.org.
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. Beginning September 15, 2021, any electronic submission that does NOT pass the aforementioned validation criteria will be rejected. Our PointCross Validation engine has 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.