Learn more about eDataValidator
Validate SDTM, ADaM, SEND, and Define.XML with confidence
End-to-end conformance with FDA, PMDA, CDISC, and CORE - across clinical and nonclinical submissions.
Clinical & Nonclinical Data Conformance
Trusted by biopharma sponsors and CROs submitting to FDA and PMDA
Sponsors
Prepare IND, NDA, and BLA packages with built‑in conformance checks and audit‑ready exports.
CROs
Deliver validated SDTM, ADaM, and SEND datasets consistently across programs and studies.
Standards & QA
Enforce SDTM/ADaM conformance, monitor trends, and simplify audit preparation.
Who it’s for
Built for regulated data teams
Whether you’re a sponsor, CRO, or a data standards group, eDataValidator streamlines validation at every stage - from dataset preparation to final submission.
MODULES
One platform, three powerful modules
eDV SaaS Application
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Manage multiple studies and projects
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Select rulepacks: FDA, PMDA, CDISC, CORE, Extended
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Track validation history and severity trends
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Role-based access and audit-ready exports
eDV Desktop (Included)
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Fast, offline validation for SDTM/SEND prep
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Simplified Define and TS.xpt workflows
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Ideal for early QC and dataset iteration
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Role-based access and audit-ready exports
QC Dashboard
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Severity trend charts and delta comparisons
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Drill down to dataset, variable, and rule
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Exportable reports for submissions and audits
Coverage
Comprehensive rules coverage
Run validations across clinical and nonclinical data against multiple rulepacks in one pass, including CDISC Controlled Terminology and Define‑XML checks.
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FDA: SDTM, SEND; Validator Rules v1.6
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PMDA: SDTM, ADaM, Define; PMDA 5.0
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CDISC: SDTM, ADaM, SEND; Define‑XML 2.0 / 2.1
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CDISC CORE: Checks aligned to CORE guidance
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Extended Checks: PointCross & sponsor‑defined
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CT Support: All CDISC CT versions + proprietary CTs
Capabilities
Key capabilities
Multi‑format validation
Validate CSV, XPT, SAS7BDAT, and Excel for SDTM, ADaM, SEND, and Define‑XML.
Define‑XML checks
Validate Define‑XML 1.0, 2.0, and 2.1 with PMDA and CDISC rulepacks.
Automation & CLI
Integrate with CI/CD pipelines for reproducible, scalable validation.
Consistency checks
Check study data structure and metadata consistency across datasets.
SDRG & Define
Generate SDRG drafts and define files; convert XPT to Excel.
Trends & versions
Compare validation results across versions and track issue resolution.
Process
How it works
1) Load datasets
Use SaaS or Desktop to load clinical and nonclinical study data.
2) Run rulepacks
Select FDA, PMDA, CDISC, CORE, and extended checks in one pass.
3) Review & export
Resolve issues, compare versions, and export audit‑ready reports.
Video walkthroughs
Explore eDV in action
Start your free 30‑day trial
Instant access to eDV SaaS and the included Desktop client. No credit card required.