About Us

We accelerate the FDA approval process

At Pinnacle 21, we ensure that your data complies with new FDA regulations, so your review process is efficient and trouble-free — getting new drugs to market faster.

Our flagship software, Pinnacle 21 Enterprise (used at FDA under the name “DataFit”), provides the biopharmaceutical industry with the key to a fast, efficient drug review process. It’s the technology that drives FDA’s 21st Century Review Initiative, ensuring that submission data is compliant, useful and ready for review — which enables a more efficient review process.

Why does this matter to you? Because if your submission data gets the “green light” when you run it through Pinnacle 21 Enterprise, you know it’ll pass when FDA runs it through DataFit.

From the creators of OpenCDISC

Our history is almost as interesting as our present. In 2008, our principals created the game-changing OpenCDISC Validator — an open-source tool for ensuring SDTM and ADaM compliance. It has since become the life-science industry’s “universally adopted standards compliance tool.”

Following its success, Max Kanevsky, the organization’s President & CEO, formed Pinnacle 21 with his team — a company dedicated to creating new, evolutionary software innovations to support regulatory submissions.

Our leaders have worked with FDA for many years, and have an unparalleled understanding of the submissions process, regulatory guidelines related to electronic data submission, requirements for clinical datasets, and the various standards and documents related to the process. Pinnacle 21 is also a Platinum Member of CDISC, as well as a CDISC technology partner.