Define-XML is the metadata that describes the content and formatting of submission datasets and the case report tabulation data. It’s needed to help reviewers understand the data they are reviewing.

In the past, sponsors submitting to FDA were required to submit a PDF describing their submission datasets. As we all know PDF is great for viewing on-screen or printing, but the information inside ...

FOSTER CITY, Calif., July 20, 2022 (GLOBE NEWSWIRE) -- PointCross Life Sciences announced today the full complement release of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML ...

PointCross Life Sciences announced today the full complement release of its eDataValidator™ (eDV) for validating SDTM, ADaM, SEND and Define.XML data for conformance to prevailing FDA, CDISC, and PMDA ...