a one stop solution for your
validation requirements across
clinical 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.
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.