The History of Pinnacle 21

It was late 2007. Mad Men was the hottest show on TV. The BlackBerry was still the most popular smartphone. Senator Barack Obama was securing his party’s nomination for the next presidential election. And a young clinical data exchange specialist named Max Kanevsky was contemplating the future of the biopharmaceutical industry.  

During his tenure at Merck, Max had been responsible for integrating the company with many external partners (e.g., laboratories, CROs, joint ventures, technology providers), working with many non-standardized sources of data. Though the norm, gathering all that disparate data and mapping it into Merck’s internal standard was a huge challenge. When the Clinical Data Interchange Standards Consortium (CDISC) started to make headway in its mission to develop a global set of standards, it marked a new beginning. CDISC would eventually define the standards for the entire industry.  

But Max wondered how sponsors would possibly manage such a sea-change. At the time, software options to help ensure a submission’s compliance with FDA business rules were limited. WebSDM offered limited performance and capabilities, at a price point that was prohibitive to many. Meanwhile, Max was helping Merck with its early manual implementations of CDISC standards, including LAB, ODM, and SDTM, which were difficult and time-consuming. Each new challenge provided an obstacle that could threaten FDA approval of any given drug. There had to be a better way. But what?  

Then, chance intervened. In March 2008, Max met Drupal founder Dries Buytaert at a networking event in Boston. Dries told him the story of how and why he created Drupal and shared his philosophy that an open-source project that helps a community can flourish and become the basis for a high-growth business. Max had been starting to contemplate a new type of software—one that was both robust and affordable—to help sponsors ensure SDTM and ADaM compliance without creating budgetary problems. Dries had mentioned the Darwinian nature of open-source projects: how a community can create something that works through the interconnectedness of a nurturing ecosystem. Max was convinced that open source was the way to go. 

The story of Pinnacle 21 truly began here. 

Max had his software idea and his approach. Now he needed some talent to help bring it to fruition. First, he went to his wife, Inna Lernerman, a developer and web systems analyst who understood his vision and had the practical know-how to help actualize it. Next, he sought the advice of a former professor at the University of the Sciences, who introduced Max to a particularly talented young developer named Tim Stone. Tim, Max, and Inna started collaborating, and before long, they ventured into a working relationship that would result in the creation of what became known as Pinnacle 21 Validator.  

When the validator launched in October 2008, it created an immediate buzz in the industry. At a time when there was very little help for developers tasked with implementing standards at their companies, the P21 validator was something of a gift. It was quick and easy to download, absolutely free, and it worked. Because of the open, collaborative, and vendor-neutral process by which it was developed, it reached developers as a democratized solution. This open-source advantage empowered organizations to approach compliance challenges with confidence. 

The ethos was clear from day one: we started by trying to save ourselves some keystrokes in cleaning up clinical data. Then we ended up helping improve the clinical trial and regulatory process itself. 

Word started to spread among developers. But the project’s first significant break occurred in 2008, when CDISC Vice President Frank Newby learned about the software at a NJ CDISC User Group gathering. Frank was so enthusiastic about the software that he invited Max and the team to speak at the CDISC Interchange later that year. This helped expose the open-source software to a much wider audience, and P21 validator began to take off. 

The next step was getting the validator recognized by the FDA. At the time, the use of CDISC standards was only a suggestion, and one project manager in particular, Amy Malla, was an outspoken advocate for fully adopting those standards at the FDA. While leading that progress, Amy also investigated and evaluated different software platforms, ultimately recommending Pinnacle 21 Validator as the tool for validating those standards. Dr. Chuck Cooper of the FDA CDER Computational Science Center also played a pivotal role, advocating for a transparent submission review process that leveraged open-source tools like the P21 validator. With early adoption by the FDA, Pinnacle 21 gained rapid credibility and became central to the regulatory landscape. 

By 2010, Max and other key members of Pinnacle 21 began to face new challenges. User feedback revealed a gap in the product’s capacity to handle intricate submissions managed by large, enterprise-level teams. Additionally, the lack of funding began to limit the open-source project from reaching its full potential. 

The solution? Pinnacle 21 Enterprise. Launched in 2011 as a commercial evolution of the platform, it offered comprehensive tools designed for large-scale submissions, validation scorecards, and cloud capabilities. By charging commercial licensing fees, the company could not only expand its product offerings but also sustain the original open-source project. 

Learn the key differences between P21 Community and Enterprise. 

Pinnacle 21 also offers various modules to enhance clinical trial data management and validation. These advanced modules include the ability to manage non-CRF data and accelerate study set up with a clinical metadata repository, ensuring compliance with CDISC standards, and facilitating collaborative workflows, ultimately speeding up clinical trial processes and improving data quality.   

By 2015, Pinnacle 21’s success and innovative platform had caught the attention of PMDA in Japan, expanding the company’s reach globally alongside its established FDA partnership.  

Effective October 1st, 2020, China’s NMPA began to accept CDISC submissions. To support this initiative, Pinnacle 21 released a new Chinese-language validation engine, available in both P21 Enterprise and Community. This engine supports datasets with Chinese-encoded characters and displays rule messages and descriptions in Chinese translation. 

Today, Pinnacle 21 Enterprise, powered by Certara since its 2021 acquisition, continues to drive global clinical compliance and innovation. Its empathetic, responsive, and trusted foundation remains at the heart of its mission, helping companies worldwide manage clinical data, accelerate trials, and deliver life-changing treatments.