eDataValidator

The eDataValidator (eDV) is a powerful and comprehensive validation tool for all clinical and nonclinical study submission datasets to the FDA or PMDA.

eDV SaaS Application

Secure space to load and validate study datasets and review the validation status over time

eDV Desktop (included)

eDV Desktop for all subscribers to support SDTM, SEND preparation and generation of Simplified TS.xpt

QC Dashboard

Dataset QC Dashboard to verify, compare the validation reports across study load version and monitor the datasets quality
  • 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
  • Converting XPT datasets to an Excel format

Supported Validation Rules

FDA Validator Rules v1.5
PMDA Validation Rules v1.0 (Define)
PMDA Validation Rules v2.0 (SDTM, ADaM)
CDISC SEND Conformance Rules v4.0
CDISC SDTM Conformance Rules v1.1
CDISC Define Conformance Rules for 2.0 & 2.1
FDA Rejection Criteria (FDA TRC Rules)
PointCross Extended checks
CDISC ADaM Conformance Rules v4.0

Upcoming rulesets

PMDA Validation Rules v2.0/3.0 (Define)
PMDA Validation Rules v3.0 (SDTM/ADaM)
CDISC SDTM Conformance Rules v2.0