Industry Standard Validation

eDataValidator™
Limitless Compliance

The comprehensive validation tool for all clinical (SDTM, ADaM) and nonclinical (SEND) datasets. A single, powerful solution for IND, NDA, and BLA preparation.

* No credit card required for trial

Validation Capabilities

  • ✓ FDA & PMDA Submission Ready
  • ✓ Clinical (SDTM, ADaM) & Nonclinical (SEND)
  • ✓ SaaS & Desktop Versions Included
  • ✓ Unlimited Validation Cycles
  • ✓ Define.xml 2.0 & 2.1 Support

One Subscription, Two Powerful Modes

Every subscription includes both the secure cloud-based SaaS application and the offline-capable Desktop version.

INCLUDED

eDV SaaS Application

Secure, 21 CFR Part 11 compliant space to load and validate study datasets. Review validation status history over time and collaborate with your team.

eDV Desktop

Work offline securely. Ideal for remote Sponsor/CRO users or programmers who need speed without uploading data. Updates notified automatically.

Unified QC Dashboard

Verify and compare validation reports across study load versions. Monitor dataset quality trends over time with our comprehensive QC Dashboard.

  • 📊 Verify structural & metadata correctness
  • 📊 Compare reports across versions
  • 📊 Monitor dataset quality trends
  • 📊 Generate simplified TS.xpt

Comprehensive Rules Engine

Validates against all major regulatory and industry standards.

🛡️ FDA

SDTM & SEND
  • • FDA Validator Rules v1.6
  • • FDA Validator Rules v1.5
  • • FDA Rejection Criteria (TRC)

🌏 PMDA

SDTM, ADaM, Define
  • • PMDA Validation Rules 6.0
  • • PMDA Validation Rules 5.0
  • • PMDA Validation Rules v4.0
  • • PMDA Validation Rules v3.0

💾 CDISC

Conformance Rules
  • • SEND Conformance v4.0
  • • SDTM Conformance v2.0
  • • ADaM Conformance v5.0 & v4.0
  • • Define 2.0 & 2.1 Conformance
  • • CDISC Open Rules Engine (CORE)

+ Includes PointCross Extended Checks & Proprietary CT Support

More Than Just Validation

📄

Any Format

Validate CSV, XPT, SAS7BDAT, or EXCEL files.

✅

Define.xml

Validate versions 1.0, 2.0, 2.1 with PMDA & CDISC rules.

⌨️

CLI Integration

Command Line Interface for pipeline integration.

⬇️

Conversions

Convert XPT datasets to Excel format easily.

Part of the Xbiom Platform

eDV is also available as part of Xbiom, a platform for automated management of trial and study data. It works in concert with Smart Transformation tools to generate an accessible, interactive, findable UDM store.

Automated Export

Automatically export from UDM to SDTM datasets, drastically cutting down cycle time after a database lockout.

Frequently Asked Questions

Is eDV 21 CFR Part 11 compliant?

Yes, the server-based eDV SaaS application is fully 21 CFR Part 11 compliant, ensuring secure records and audit trails.

Is there a limit on validation cycles?

No – there is no limit. You can run unlimited validation cycles to ensuring your data is perfect before submission.

Does PointCross support validation (IQ / OQ / PQ)?

Yes, PointCross provides support for clients’ validation with evidence for IQ, OQ, and PQ.

How do I access eDataValidator?

You can sign up for a free 30-day trial (no credit card required). It is available as a SaaS monthly subscription.

Ready to Validate Your Submission?

Join small biotech to large pharma companies who trust eDataValidator for their IND, NDA, and BLA submissions.

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