eDataValidator (EDV)

( Powered by AWS ) is a powerful and comprehensive validation tool for all clinical and nonclinical study submission datasets to the FDA or PMDA. 

EDV can be purchased from the AWS Marketplace by clicking here. A dedicated hosted environment is also available with a direct negotiated contract with PointCross Inc.

Video tutorial playlist on EDV can be found here

What you get with EDV:

  • A Validator for SDTM, ADaM, SEND and define.xml validating them against
            - 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. ( Additional validation rules rules that we built with our experience )

  • 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.

    QC Dashboard 

    Issue Drill down

    Issue Assignment

    Validation compare between versions of dataset
  • 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 road map and provide an issue management registry.

Please reach us at edatavalidator@pointcross.com to learn more about the eDataValidator.