FDA Study Data Validator (FDA SDV)

The FDA Study Data Validator provides a Clinical Data Interchange Standards Consortium (CDISC) compliant study data validation capability. The CDISC is a standards development organization which provides standards and best practices for medical research data linked to healthcare. The FDS SDV allows ORA to validate the clinical and non-clinical datasets for electronic submission to the FDA. The system is vital to accelerate the process of submitting regulatory packages to the FDA for investigational product applications. FDA SDV is an Enterprise system providing visibility of data compliance across the Command and ensuring data integrity of the clinical product lifecycle.

Data Validation

• Validate SDTM, ADaM, SEND, BIMO, and Define.xml
• Comply with CDISC standards and regulatory requirements.
• Metadata driven and configurable.
• Data Fitness Score
• Monitor data quality improvement over time.
• View and track changes across historical validations
• Export Validation Reports
• View changes from Last Validation
• Submission Checklist

Issue Management

• Delegate and fix issues across decentralized teams and sites
• View a breakdown of Issues by Impact, Status, and Source
• Comment on issues, reuse your company-approved explanations, and share custom Fix Tips as advice for your peers.
• View, sort, filter, tag data issues intuitively, with options for bulk actions and dual screen view.
• Issue Management Progress to gain real-time feedback on group efforts.
• Auto-store reports and switch/compare easily to view New, Fixed, or Updated Issues
• Add issue explanations for fast production of Review's Guides for unfixable Issues.
• Issue Source tags to help categorize potential sources of the problem.
• Review Impact to see the likelihood of the issue impeding global regulatory reviews.
• Projected Score indicates what your Data Fitness score will be if issues are fixed.

DEFINE-XML Define Designer

• Create Define.xml v2.0 or Define.xml v2.1 for SDTM, ADaM, SEND, and BIMO
• Automate 80% of the Define.xml using metadata extract from validated datasets.
• Extract page numbers from annotated CRFs to populate Origin.
• Merge new cuts of data
• Generate Define.pdf
• Validate Define.xml content in real-time.

Training & Demos

If you would like to schedule a demo or training, or have any questions, please contact us.