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 ...

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.

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 ...

In just a few years, XML’s importance to Java developers has grown by leaps and bounds, especially with Web services on the scene. XML, however, is an evolving technology with numerous subtechnologies ...