eDataValidator

eDataValidator (eDV), developed by PointCross Life Sciences, is a powerful and comprehensive validation tool designed for clinical and nonclinical study submission datasets destined for the FDA or PMDA. It offers limitless validation of Clinical SDTM and ADaM as well as Nonclinical SEND, making it a single unified solution for IND, NDA, and BLA preparation. eDV is particularly well-suited for biometrics teams, biostatisticians, and SAS or R programmers who need to intermittently verify datasets throughout the lifecycle of a study.

eDataValidator is available as a SaaS monthly subscription, which includes a companion desktop version at no additional charge. The desktop version supports offline use, catering to sponsor and CRO users working in remote or offline environments. A Dataset QC Dashboard is also included, enabling users to verify and compare validation reports across study load versions and monitor dataset quality over time. Clients have been using eDataValidator for over ten years and have successfully submitted NDA and IND packages — including SEND submissions — after validating their data with eDV.

Supported Validation Rule Sets

• FDA (SDTM, SEND): FDA Validator Rules v1.6, FDA Validator Rules v1.5, and FDA Rejection Criteria (FDA TRC Rules)
• PMDA (SDTM, ADaM, Define): PMDA Validation Rules v3.0, v4.0, v5.0, and v6.0
• CDISC (SEND, SDTM, ADaM, Define): CDISC SEND Conformance Rules v4.0, CDISC SDTM Conformance Rules v2.0, CDISC ADaM Conformance Rules v4.0 and v5.0, and CDISC Define Conformance Rules for Define 2.0 and 2.1
• CDISC Open Rules Engine (CORE)
• PointCross Extended checks

Key Capabilities and Uses

• Validate final and interim study data against all SDTM, ADaM, and SEND files in multiple formats, including CSV, XPT, SAS7BDAT, and 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 controlled terminology versions, external dictionaries, and proprietary controlled terminologies
• Perform data consistency checks on study datasets to verify structural and metadata correctness
• Generate draft SDRG templates for SEND, SDTM, and ADaM
• Generate define files directly within the tool
• Convert XPT datasets to Excel format for easier review
• Generate Simplified TS.xpt via the eDV Desktop application
• Integrate with existing applications via a command-line interface (CLI)

Deployment and Access

• Available as a SaaS application with a secure cloud environment for loading, validating, and reviewing study datasets over time
• Companion desktop version included with every SaaS subscription, supporting offline SDTM and SEND preparation
• A free 30-day trial is available with no credit card required
• No limit on the number of validation cycles that can be run
• The server-based SaaS application is 21 CFR Part 11 compliant
• PointCross provides support for client validation activities, including evidence for IQ, OQ, and PQ

eDataValidator is also available as an integrated component of the XBIOM™ platform, where it works in concert with Smart Transformation tools to automate the management of trial and study data, reconcile multiple data sources, and accelerate SDTM dataset generation after database lockout. Updates to the eDV Desktop Application are proactively communicated to all active subscribers.