...to regulatory recommendation, to industry gold standard. We’ve evolved quite a ways. 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 processes themselves. Ambition much?
Looking back, it seems obvious that clinical data would standardize, and that its processing would automate. But it’s taken—and is still taking—massive effort industry-wide. Sometimes you just have to make the future that you want to live in. Read on for our role in this change.
Developers had been implementing CDISC standards manually, or with pricey, bloated tools. (No offense.) Inspired by open source, our founders made their own. It was free, robust, and plug-and-play easy. They uploaded it in a hotel lobby at 4 a.m. and debuted at a CDISC conference. Downloads spiked: developers loved it. Our story thus finds its theme: grassroots traction meets high-profile exposure.
In the before times, complying with CDISC standards was optional. The FDA’s center for biologics wanted to make compliance a must, and evaluated some potential software platforms. They invited us to an FDA conference, where the agency shared their surprise choice of OpenCDISC to validate submissions. We hadn’t even known there was a contest. This affirming shock showed we were doing things right.
Advanced users wanted more. Our early adopters had been generous with testing and feedback. They had a clear need for something largescale to handle complex submissions across many teams. Squeezed between feature requests and tight funding, we chose to launch our expanded commercial version: Enterprise. Its license fees both funded the new features and also sustained our open source project.
The FDA needed a transparent, standardized platform to screen incoming submissions. In parallel to the choice of OpenCDISC, the agency’s center for drugs asked, “Know of anything automated that runs on a server and can generate reports?” Enterprise, our flagship cloud-based product, fit the bill. The FDA upgraded to Enterprise the year it was released, adopting it under the name “DataFit.”
Japan’s PMDA saw our success with the FDA and wanted in. They approached us via intermediaries, requesting a platform to validate submission data. We contracted to license Enterprise to them, putting the PMDA on equal footing with their American counterparts and making Pinnacle 21 a truly global player. We now had best-in-class status in two key global pharmaceutical markets.
Our two brands shared the same creators. And we needed to make that clearer. Before, we had two separate sites: OpenCDISC and Pinnacle 21. So we unified them all under the Pinnacle 21 umbrella, with the open source as Community and the licensed version as Enterprise. Now we have brand continuity for users who upgrade into our Enterprise family.
Our users wanted to learn and share stories. Mini conferences in Boston, New Jersey, and San Francisco went well. But the 4th event hit a booking snag, so we self-hosted in Philly instead, with 1.5 days of expert talks, industry insights, and networking. To celebrate our users, we booked a premium venue, splurging on food and entertainment. Our first P21 LIVE welcomed 65 guests from 3 continents!
Silicon Valley comes to Blue Bell, PA! After visiting the Amazon Spheres in Seattle, we decided to give our staff the best. We gutted the top floor of our office park and let in lots of light. Inside: snack kitchen, game room, on-site gym. Outside: pond, much green, life-sized chess, Adirondack chairs. At the grand opening, we wowed guests with a space fit for the super talent that work here.
It was time for direct contact with the PMDA and our clients in Japan. An in-country presence would keep us ahead of local regulatory changes. (We also wanted to sip sake and see sakura blossoms, but priorities!) We secured an office in Tokyo, hired a local director, and got through the red tape. We showed users abroad, “We’re here for you, and here to stay.” Thrilling to be both small and global.
Employees appreciate our culture, a rare mix of nurturing and empowering. New team members found us through referrals from current staff or, at times, our barber. Then Fortune Magazine made it official, adding us to their Best Small & Medium Workplaces. We scored a gratifying 100%—putting a number on a truth we already knew. The added recognition spotlights our place in the local talent market.
We’re supporting data validation for Warp Speed vaccines fast-tracked for FDA approval. We’re even consulting pro bono for promising sponsors new to the submissions process. We also funded local mask and PPE production for our health care heroes. And, of course, we continue to assist and advise clients with ongoing trials, as some clinic visits get decentralized and complicate data processing.
As you click through our timeline, you’ll notice our story has some recurring themes. You often hear in HR that past behavior is the best predictor of future behavior. If so, we’re on the right path. Here are four traits we’re known to be.
We too are users of our own software, so we feel for you. In fact, we built it for ourselves, in our past lives as data exchange specialists. Our software is truly made by and for real-life standards, programming, and analytics teams.
Some startups never get that elusive “product-market fit.” We had it from the start. Our users gave us strong pull, and we built out a platform that solves real needs for pressing use cases. No $400 smart juicers are in our product pipeline.
Industry recognition by CDISC, the FDA and PMDA, and the majority of pharma, biotech, and CROs has made us a familiar name in our niche. From our 2016 TOPRA award to our 2019 Great Place to Work status, we have a track record success in the world of clinical data.
We pay it forward. From the lonely first months coding our open source project, to our current pro bono support for COVID-19 vaccine initiatives. We know well the principle of “give before you get.” Karma’s quite nice if you treat her well.
And one of its key characters is…you! As a customer, you shape our future features and put our platform to work in service of life-saving treatments. As a teammate, you create value that powers us forward. Our narratives intersect. Read on to learn more about our teams, products, and openings.
Your challenges may seem dauntingly unique, but our leaders really have seen it all. They run a nimble team, stay hands-on, and steer towards success. Here are some faces to go with the names on our articles, webinars, and WebEx handles.Meet Our Leaders
Pinnacle 21 Enterprise assures you that your clinical data are fit to submit. See how pharma, biotech, CROs, and regulators accelerate clinical trials with our data platform. Optimize your data journey from collection and processing to submission.Explore Enterprise
We’re a flat team alive with founder energy. We aren't big on office politics or saying, “Not my job.” 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.See Open Positions
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