Validate once. Submit with confidence.
eDataValidator™ (eDV) is a comprehensive validation tool for clinical and nonclinical study datasets submitted to the FDA or PMDA. One solution for IND, NDA and BLA preparation. No limit on validation cycles.
SaaS, Desktop, and QC Dashboard
Every eDV subscription includes all three modes, with no extra charge for the desktop version.
Secure space to load, validate and review
A cloud-hosted, 21 CFR Part 11 compliant environment where teams can load study datasets, run multi-ruleset validation, and review the validation status of studies over time. No infrastructure required.
- ✓ Multi-ruleset validation in one session (FDA, PMDA, CDISC)
- ✓ 21 CFR Part 11 compliant server environment
- ✓ Validate XPT, SAS7BDAT, CSV and Excel formats
- ✓ Review and track validation history over time
- ✓ IQ/OQ/PQ support available
Full eDV capability, offline and included
Every SaaS subscriber receives the eDV Desktop at no additional charge. Supports SDTM and SEND preparation, generation of Simplified TS.xpt, and works entirely offline. Ideal for programmers working in isolated environments.
- ✓ Included with every SaaS subscription, no extra charge
- ✓ Works fully offline on desktop environments
- ✓ Generate Simplified TS.xpt for SEND submissions
- ✓ Supports SAS, R and Python programmers
- ✓ Automatic update notifications for active subscribers
Monitor dataset quality across versions
The QC Dashboard lets you verify, compare, and track validation reports across study load versions. Monitor dataset quality trends over time and catch regressions before submission.
- ✓ Compare validation reports across study versions
- ✓ Monitor dataset quality trends over submission lifecycle
- ✓ Catch regressions introduced by dataset revisions
- ✓ Team-level visibility across multiple studies
Every major regulatory ruleset
FDA, PMDA, and CDISC rules in a single tool. Always current with the latest published versions.
FDA Rules
- v1.6 FDA Validator Rules
- v1.5 FDA Validator Rules
- TRC FDA Rejection Criteria
PMDA Rules
- v6.0 PMDA Validation Rules
- v5.0 PMDA Validation Rules
- v4.0 PMDA Validation Rules
- v3.0 PMDA Validation Rules
CDISC Conformance
- v4.0 SEND Conformance Rules
- v2.0 SDTM Conformance Rules
- v5.0 ADaM Conformance Rules
- v4.0 ADaM Conformance Rules
- 2.0/2.1 Define Conformance Rules
CDISC Open Rules Engine (CORE)
Full support for the CDISC CORE open-source rules engine, providing community-maintained and regularly updated conformance checks for SDTM, ADaM and SEND.
PointCross Extended Checks
Proprietary extended checks developed by PointCross from 10+ years of SEND and SDTM submission experience, catching common submission issues beyond the standard rulesets.
What you can do with eDV
From interim dataset checks to final submission packages, eDV handles every stage of the validation workflow.
Validate final and interim study data against all SDTM, ADaM & SEND files in any format: CSV, XPT, SAS7BDAT, or Excel.
Validate Define.xml (versions 1.0, 2.0, and 2.1) using PMDA and CDISC Define validation rules.
Validate study data against all published CDISC CT versions, external dictionaries, and proprietary controlled terminologies.
CLI integration to embed validation into existing applications, pipelines, and automated build systems.
Perform Data Consistency checks on study datasets to verify structural and metadata correctness across domains.
Generate draft SDRG templates for SEND, SDTM and ADaM, ready for review and finalization.
Generate define files directly from validated datasets for inclusion in submission packages.
Convert XPT datasets to Excel format for review, annotation, and sharing with non-technical stakeholders.
How do I access eDataValidator?+
Users can download the eDataValidator directly by filling the form on the right-hand side of this page. Upon signing-up users are provided with a free 30-day trial of eDataValidator (No credit card required). The eDataValidator is available as a SaaS monthly subscription, which includes a companion desktop version with the same software.
If you have any further questions on getting started or accessing the eDataValidator, please do not hesitate to contact us.
What can eDataValidator (eDV) be used for?+
eDV is useful for biometrics teams, biostatisticians and SAS or R programmers to intermittently verify their datasets while the study is ongoing. Users can validate their SDTM & ADaM datasets from Clinical Trials and SEND datasets from Nonclinical Trials against FDA, CDISC and PMDA rule sets.
eDV is also available as part of Xbiom, a platform for automated management of trial and study data to reconcile multiple sources into a single integrated longitudinal view of subjects in ongoing or complete 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.
Is eDV 21 CFR Part 11 compliant?+
Yes, the server based eDV SaaS application is CFR Part 11 compliant.
Does PointCross support validation (IQ / OQ / PQ)?+
Yes, PointCross provides support for clients' validation with evidence for IQ, OQ, and PQ. We have clients who have gone through this validation.
Is there a limit on the number of validation cycles I can run?+
No – there is no limit.
Is the Desktop Application included with my eDV SaaS monthly subscription?+
- 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.
Have Sponsors submitted SDTM/ADaM/SEND datasets to regulatory agencies after validating with eDV?+
- Yes – clients have been using eDataValidator for over 10 years and have successfully submitted NDA and IND submission packages after validating their data with eDV.
- 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.
Start your free 30-day eDV trial
No credit card required. Full SaaS access plus the desktop version. Start validating your datasets today.
