Update: On 28th February 2023, PMDA has released a new validation rule version 4.0 for SDTM and Define.XML. Click here to download the ruleset. eDV has incorporated these updated rulesets on April 28th, 2023
What is 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 offers limitless validation of Clinical SDTM and ADaM as well as Nonclinical SEND, making this a single solution for IND, NDA and BLA preparation.
Secure space to load and validate study datasets and review the validation status over time
eDV Desktop for all subscribers to support SDTM, SEND preparation and generation of Simplified TS.xpt
Dataset QC Dashboard to verify, compare the validation reports across study load version and monitor the datasets quality
Supported Validation Rules
- FDA Validator Rules v1.6
- FDA Validator Rules v1.5 (SDTM, SEND)
- PMDA Validation Rules v4.0 (SDTM, ADaM)
- PMDA Validation Rules v3.0 (SDTM, ADaM)
- CDISC SEND Conformance Rules v4.0
- CDISC SDTM Conformance Rules v2.0
- CDISC ADaM Conformance Rules v4.0
- CDISC Define Conformance Rules for Define 2.0 & 2.1
- PMDA Define Rules v4.0 (SDTM, SEND & ADaM)
- PMDA Define Rules v3.0 (SDTM, SEND & ADaM)
- FDA Rejection Criteria (FDA TRC Rules)
- PointCross Extended checks
Uses of eDataValidator
- 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 draft SDRG template for SEND and SDTM
- Generate define files
- Converting XPT datasets to an Excel format
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 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.
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 Trails 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.
eDataValidator is available for individual subscribers at $170 / user / month. Additional discounts are available for 3+ users within an organization, and enterprise pricing for 50+ users is $120/user/month, or less if part of a wider Xbiom™ subscription.
Yes, the server based eDV SaaS application is CFR Part 11 compliant.
Yes, PointCross provides support for clients’ validation with evidence for IQ, OQ, and PQ. We have clients who have gone through this validation.
No – there is no limit.
- 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.
- Yes – a number of clients have been submitting NDA and IND submissions for close to 10 years after validating their data with eDataValidator.
- 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