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.
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.
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.
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.
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.
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.
Little things make
a big difference
Simple IntegrationVia 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 SecurityEnterprise’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 AccessibilityPinnacle 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.