CLINICAL

PointCross Testing

PhUSE Americas Winter SDE

We presented a paper at the PhUSE 2022 Americas Winter Single Day Event on the topic of Universal Data Model (UDM) being leveraged to streamline pathways to SDTM and ADaM Standards.  This paper introduces Xbiom to automatically map raw data to SDTMs. To read the paper, please click on the link below: Universal Data Model (UDM)...

PointCross releases eDataValidator for SDTM, ADaM, SEND, and Define.XML conformance to prevailing FDA, CDISC, and PMDA rules

PointCross Life Sciences has released the full complement of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA rules. In use by 5 of the top 10 large pharma and CROs, eDV has now been released as a standalone tool in response to growing demand from sponsor Clinical...

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,...

Effective March 15, 2021: Support for SEND DART IG 1.1 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 EFD, Fertility and Early Embryonic Development and Pre-Natal and Post Natal...