
Validation
Analyze and measure your data quality, see how issues affect the review process, and get instruction on how to fix them.
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Define.XML
Our highly intuitive and automated tool guides you through the process of creating 100% compliant Define.xml 2.0 files.
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Reviewer's Guide
An SDRG gives FDA reviewers a clear understanding of your data, and we give you an automated process to create them.
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Data Standardization Services
We will ensure that your study data and supporting documentation are compliant with FDA’s requirements, and ready to support the regulatory review process.
Learn moreWho is Pinnacle 21?
Pinnacle 21 is the industry leader in software and services for managing CDISC compliance, clinical data quality, and FDA submission readiness. Our flagship software, Pinnacle 21 Enterprise, is used by the FDA (under the name “DataFit”) to screen incoming submissions…
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