In the Beginning

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. And 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 Birth of OpenCDISC

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 one of his former professors at the University of the Sciences, who introduced Max to a particularly talented young developer named Tim Stone. Tim, Max, and Inna started talking, and, before long, ventured into a working relationship that would result in the creation of OpenCDISC Validator.

When OpenCDISC Validator launched in October 2008, it created an immediate buzz in the industry. In a context where there was very little help for developers tasked with implementing the standards at their companies, Validator was something of a gift. It was quick and easy to download, it was absolutely free, and it worked. And because of the open, collaborative, and vendor-neutral process by which it was developed, it reached developers as a democratized solution. Every individual had a voice; and every problem could be attacked and solved by the community.

Adoption by the Industry

Word started to spread among developers. But the project’s first 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 Validator really started to take off.

The next step was getting Validator recognized by the FDA. The use of CDISC standards was, at the time, only a suggestion; and one project manager in particular, Amy Malla, was perhaps the loudest advocate for full FDA adoption of those standards. While leading that progress, Amy also investigated and evaluated different software platforms that could be leveraged by the FDA for that very purpose. After much consideration, Amy and the FDA selected OpenCDISC Validator to be that tool.

Around the same time, Dr. Chuck Cooper was leading the formation of the new FDA CDER Computational Science Center. Dr. Cooper was vocal in promoting open source software as essential in supporting a modern submissions review process that would be transparent and standardized. With Validator being the open source software of choice at the FDA, the momentum shifted dramatically. Max’s vision had become reality.

Pinnacle 21

By 2010, Max and other key members of OpenCDISC found themselves running into certain barriers. First, there were users who simply needed the software to do more. For submissions that were handled by numerous professionals and involved large numbers of studies, the limitations of the open source product were salient. Second, a dearth of funding was holding the open source project from reaching its full potential.

Both problems, it seemed, could be remedied by the same solution: a commercial, enterprise-wide version of the software. Such a product would be designed to support large submissions with many users, providing all the tools, bells, and whistles advanced users needed. And by charging commercial license fees for its use, the open source project would have the financial backing it needed to continue and evolve.

So, Max and the team went to work. And in August 2011, Pinnacle 21 — the commercial arm of OpenCDISC — was born. From this new company came a groundbreaking flagship product: OpenCDISC Enterprise. This enterprise-wide solution is cloud-based, provides validation scorecards, enables issue management, creates Define.xml, generates customized reports, and much more. Moreover, OpenCDISC Enterprise was found to be so robust and comprehensive, the FDA adopted it as its screening software for incoming submissions. (Internally, the FDA refers to the software as “DataFit.”)

Since then, Pinnacle 21 has broadened its capabilities and evolved into the industry leader in software and services for managing CDISC compliance, clinical data quality, and FDA submission readiness. In addition to the open source and commercial software products, Pinnacle 21’s team of experts support the industry in a variety of ways: submission reviews, creation of Define.xml and SDRGs, CDISC consulting, CRO oversight, and more. They also provide free educational webinars throughout the year, and have even taken to the road with “OpenCDISC Live” events — gatherings where users can meet Max and the Pinnacle 21 staff face-to-face, ask questions, collaborate, and learn.

In short, Pinnacle 21 provides the solutions, knowledge, and experience required to give you the best possible chance of achieving FDA approval.

“This, really, is just the beginning,” says Max. “The standards will keep changing, and it might be another decade before we’re all speaking the same language. We understand the importance of our mission to help pharmaceutical companies, CROs, and regulatory agencies exchange data in standardized formats, no matter what challenges the industry will have to face in the months and years to come.”