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 1.5
      • PMDA Validation Rules 1.0 (Define)
      • PMDA Validation Rules 2.0 (SDTM, ADaM)
      • CDISC SDTM Conformance rules 1.1
      • CDISC Define Conformance rules for 2.0 & 2.1
      • FDA Rejection Criteria (FDA TRC Rules)
      • PointCross Extended rules
  • Upcoming releases will include the following rulesets:
      • CDISC SEND Conformance rules 4.0v
      • PMDA Validation Rules 2.0v (Define)
      • ADaM Conformance rules 3.0v
  • 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.
    • Ability to compare the eDV validation report with any other validation report.
    • Gives data preparer’s more confidence to commit their script and dataset changes to their master repository.
    • Ability to save the Dataset to Excel( xpt, sas7bdat)
    • Trial Summary (TS.xpt) generation for current and legacy studies
    • nSDRG Template Generation
  • 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.