Be confident: See a preview of your data fitness results before even giving your data to the FDA or PMDA.

GET FIT TO SUBMIT

Work across teams to manage issues. Toss and trace error fixes from sponsor to vendor to lab site, and back again.

COLLABORATE BETTER

Why level up to Enterprise? Because we streamline your workflow to quickly broker data into breakthroughs.

EXPLORE ENTERPRISE

Pinnacle 21 has joined forces with Formedix!
Together, we form a comprehensive solution for delivering faster trials from design to submission.

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We're optimists who work smart. Team players who get __it done. You too? Then come on and join us!

SEE OPEN POSITIONS

Our Elevator Pitch (Read Time: 21 seconds)

The lifeline of all health sciences is data.

In our data pipeline, clinical trial data learn to speak the same language. With reliable data in hand, clinicians and statisticians can confidently mine the right findings, and regulators can see the merits of your treatment. The end result: clean, consistent datasets that speed lifesaving cures to market.

Pinnacle 21 offers a broad suite of solutions for your data needs: speccing, mapping, cleaning, checking, comparing, transforming, converting. More verbs are in the works. Begin updating your process with our four foundational modules.

VALIDATION

Analyze your data quality, see issues that affect FDA/PMDA review, and get insights into fixes with our leading engine.

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ISSUE MANAGEMENT

Delegate, fix, or explain issues across decentralized teams and sites. No more email attachments.

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DEFINE.XML

Create 100% compliant Define.xml files with our intuitive, automated designer.

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Reviewer’s Guide

Advocate for your data and share their full context in our xDRG creator.

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FDA/PMDA COMPLIANT: Your Home-field Advantage

Why choose Enterprise?

Are you a biotech startup? A Top 5 Pharma with 150+ compounds? Either way, you may dread regulatory data submissions. But there’s good news. The reviewers at the FDA/PMDA use our Enterprise platform to assess your data—the very same platform we give you. Enterprise takes you beyond compliance and gives you clean-cut confidence. See how your data will be seen. Answer questions before they’re asked. With this inside view, you can sidestep rounds of queries. Every day saved adds up to valuable time for your team and invaluable health outcomes for patients.

NOW HIRING: Movers and Shakers

Ready to join Pinnacle 21?

We're a flat team alive with founder energy. We aren't big on office politics or saying, "Not my job." We're more interested in you, how relentless and resourceful you are, and how we can bring out the best in each other. You'll fit in if you like meaningful work and aspire to fix serious pain points in the world of medicine. It's a hard and worthy task. (Perks include hacker memes and origin coffee.)

“Live in the future, then build what's missing.”

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TREATMENTS APPROVED

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