1777 Sentry Parkway West
Building 17, Suite 405
Blue Bell, PA 19422
+1 (888) 507-2270
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.
The creators of OpenCDISC and DataFit: the gold standard for FDA compliance
The creators of OpenCDISC and DataFit: the gold standard for FDA compliance
The creators of OpenCDISC and DataFit: the gold standard for FDA compliance
The creators of OpenCDISC and DataFit: the gold standard for FDA compliance
The creators of OpenCDISC and DataFit: the gold standard for FDA compliance
The creators of OpenCDISC and DataFit: the gold standard for FDA compliance
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.”
"We don’t merely create software. We march into the office each day dedicated to transforming the regulatory submissions process. Yes, it’s ambitious. Yes, it’s hard. But it’s also rewarding in a way that no mere ‘job’ could ever be."
Max Kanevsky
CEO - Pinnacle 21
CEO - Pinnacle 21
"Up to half of the FDA information requests (IR) sent within the first 60 days are related to data fitness."
Booz Allen Hamilton
"Pinnacle 21 made it possible to bring data validation to everyone in a way that could support the FDA’s product review modernization goals."
PharmaVOICE
"I have religiously attended all P21 webinars that my calendar allows as I have found them extremely useful! They are proving a real forum for bridging some of the gaps between industry documentation and real-world implementation."
A Satisfied SAS Programmer
"We’re fanatical about our clients. Some had huge COVID-19 datasets, so our engineers revamped the engine. Processing time dropped from 10 hours to 45 minutes. This redefined ‘customer service’ for me."
Philip Johnston
Customer Success Specialist - Pinnacle 21
Customer Success Specialist - Pinnacle 21
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