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.
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 ...
The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential ...
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