eDataValidator ( 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.
- 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.
Issue Drill down
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.