The eDataValidator (eDV) is a powerful and comprehensive validation tool for all clinical and nonclinical study submission datasets to the FDA or PMDA.
- Validate final and interim study data against all SDTM, ADaM & SEND files in any format (CSV, XPT, SAS7BDAT, EXCEL)
- Validate Define.xml (version 1.0, 2.0, 2.1) with PMDA & CDISC Define validation rules
- Validate study data against all published CDISC CT versions, external dictionaries and proprietary CT’s
- CLI to integrate to existing applications
- Perform Data Consistency checks on study datasets to verify structural and metadata correctness
- Generate nSDRG template
- Generate define files (as a service)
- Converting XPT datasets to an Excel format
eDataValidator is available for download directly from our website, link here. The eDataValidator is available as a SaaS monthly subscription, which includes a companion desktop version with the same software.
To get started, you may request a free 30-day trial of eDataValidator (no credit card required). If you have any further questions on getting started or accessing the eDataValidator, please do not hesitate to reach us at edvsupport@pointcross.com.
eDV validates SDTM and AdaM datasets for Clinical Trials and SDTM SEND datasets from nonclinical studies against CDISC and PMDA conformance rules as well as FDA business rules. eDV is useful for biometrics teams, biostatisticians and SAS or R programmers who want to test the formatting and structure of their work in process datasets or the final submittable datasets.
eDV is also available as part of Xbiom, a platform for the automated management of trial and study data to reconcile multiple sources into a single integrated longitudinal view for subjects in ongoing or completed studies. eDV works in concert with the Smart Transformation tools in Xbiom to generate an accessible, interactive, findable store – the UDM – so that it can be automatically exported to an SDTM dataset cutting down the cycle time after a database lockout.
eDataValidator is available for individual subscribers at $170 / user / month. Additional discounts are available for 3+ users within an organization, and enterprise pricing for 50+ users is $120/user/month, or less if part of a wider Xbiom™ subscription.
Yes, the server based eDV SaaS application is CFR Part 11 compliant.
Yes, PointCross provides support for clients’ validation with evidence for IQ, OQ, and PQ. We have clients who have gone through this validation.
No – there is no limit.
- Yes – each subscriber is offered a companion desktop version with the same software – and there is no additional charge for the desktop version which works offline. The desktop version was created to support Sponsor and CRO users working remotely or on offline desktop environments, and for biometric and biostat programmers working with clinical trial data offline.
- Updates to the eDV Desktop Application are notified to all active subscribers.
- Yes – a number of clients have been submitting NDA and IND submissions for close to 10 years after validating their data with eDataValidator.
- We also support a number of customers ranging from small biotech to large pharma and CRO customers who have been using eDV for SEND submissions as part of IND