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.

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Who 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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Users

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Validations

“[The service] allowed us to assess the data fitness and data quality, and gave us a lot of confidence that we could use this data in our review.”

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about how P21 supports FDA’s JumpStart