Bring your data to 100% compliance

See your data the same way the regulatory agencies do. Pinnacle 21 Enterprise is used at FDA and PMDA to review incoming submissions.

Mitigate risk and accelerate the FDA/PMDA review process

Measure Your Data Fitness

Is your data "fit for use"? Measure your "Data Fitness Score" with the same tool used by FDA and PMDA. See how your data performs across six quality dimensions, including standard compliance, data quality, and more. Address potential issues before submission and avoid costly delays.

Data Fitness Scorecard

Assess Impact on Review

The quality and usefulness of your data has a huge impact on the review process, specifically the ability of FDA and PMDA to use standardized analysis and review tools. Now, you can assess your data and get a list of “Impact” grades and easy-to-follow guidance on how to address what causes reviews to fail.

Analysis Support Scorecard

Analyze Data Composition

Digging into a study and distilling its makeup and contents are no problem … if you’re a programmer. For non-techies, our tool makes it simple to assess and view the contents of a study, and look for patterns and inconsistencies. You can also search easily for test codes, terminologies, and more.

Data Composition

Collaborate with partners to achieve continuous compliance

Manage Data Issues

View, organize, and tag various data issues, and assign tasks as needed. This is a great way to communicate and collaborate with CROs, developers, and other team members to identify and resolve issues quickly — so you can close them out with confidence, and move on to what’s next.

Issue Summary

Track and Monitor Changes

Want to check your latest validation against an older one? Our tool lets you see, clearly and easily, the changes that occurred since the last time you validated your data (like “Track Changes” in Word). This simplifies the process enormously when you are dealing with data issues in large volume.

Issue Change Tracking

Use Your Custom Standards and Terminology

Now you can upload your own standards and terminology into our system, and see which are CDISC-compliant and which need work. It's a great tool for guiding CROs, and ensuring that all clinical study data are validated against your specifications.

Standards Validation

See Pinnacle 21 in Action

Request a demo

Little things make
a big difference

  • Simple Integration

    Via our REST API, seamlessly integrate with your data warehouse, statistical computing environment and/or metadata repository to enable a true end-to-end process.
  • Stalwart Security

    Enterprise’s security is enabled through stringent access controls, 256-bit encryption, and ISO 27001 certified data centers. We also leverage Aspera’s high-speed transport technology.
  • Cloud Accessibility

    Pinnacle 21 Enterprise is web-based and cloud hosted, which means it’s centralized, requires no installation or IT costs, and updates all standards and terminologies in real time.