a one stop solution for yourvalidation requirements acrossclinical and nonclinical data


The eDataValidator (eDV) is a powerful and comprehensive validation tool for all clinical and nonclinical study submission datasets to the FDA or PMDA.

eDataValidator capabilities include:

  • A Validator for SDTM, ADaM, SEND and define.xml validating them against the following:
    • FDA Validator Rules 1.3
    • PMDA Rules for SDTM
    • PMDA Rules for ADaM 1.0
    • PMDA Rules for Define.xml
    • CDISC Conformance rules 1.1 ( under development )
    • PointCross Extended rules.

  • Supports dataset as XPT, CSV, saas7bdat, CDISC DataSet Xml and Excel.
  • EDV Server – Designed for a team to monitor study progression over time:
    • Secure space to load and validate study that support SAML based single sign on for login.
    • Version control of data and validation outputs.
    • Quality control dashboard with interactive views for issue drill down and to determine if a reported issue should be reported in SDRG or if it warrants a corrective action.
    • Review the validation status over time as you get ready for submission.

    • EDV Desktop – Designed with a SDTM, ADaM and SEND data preparer in mind.
      • Has the same engine used on the server product.
      • Useful for iterative validation as data fixes are made.
      • Ability for select specific rules in focus from the ruleset to quickly check if fixes made are really addressing the validation failures.
      • Ability to automatically compare the current validation with a baseline report.
      • Gives data preparer’s more confidence to commit their script and dataset changes to their master repository.

    • CLI (command line interface) and Scripts for automatic and periodic validation of a collection of studies.
    • Periodic updates with release notes.
    • Access to PointCross Wiki page where we publish our roadmap and provide an issue management registry.
Interested in chatting further, or would like to receive a demo of the eDataValidator? Fill in the form below or email us directly at edatavalidator@pointcross.com. To access the eDataValidator from the AWS Marketplace, please click here.