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While healthcare is becoming increasingly digitized, there are still certain sectors that have yet to catch up. One of those is clinical research; in fact, Matthew Amsden, CEO, and co-founder of ProofPilot, says that it's the beginnings of trials are still being done in programs like Word or PowerPoint.
"These are effective communication tools – but they’re just that," he said. "When considering the coordination, planning, and effort needed to successfully design and execute a research trial, a word processing tool does not advance the complex components of doing effective science."
That's why he started ProofPilot, to solve these research inefficiencies, to create software that makes it possible for companies to scale and accelerate clinical research. On Monday, the company announced that it raised over $12 million in Series B financing, led by Mitsui & Co. participation of with Sopris Capital, First Trust Capital Partners, and Excelra, among others.
Founded in 2014, ProofPilot's platform allows trial sponsors to design their trials by choosing from libraries of measurements, assessments, and functional elements, and then simulate exactly how a participant or study site staff is going to experience a trial protocol. Customers can also create options based on feedback from internal and external stakeholders. Once a sponsor is satisfied, they can then launch the trial to participants and study site staff; ProofPilot is a hybrid trial platform, meaning it supports activities that can take place via telemedicine, remote/online, and in-person.
Once launched, ProofPilot allows sponsors to track progress on study tasks and review study results. The company also ensures every IRB-approved study adheres to rigorous compliance and ethical principles as covered by HIPAA, CFR Part 11, and GDPR.
So far, over 300 studies have been designed on the platform, across a wide variety of interventions, organizations, and intentions. While ProofPilot is built for career health science researchers in academia, pharma, and medical device industries, it's also designed to be accessible to what Amsden calls, "individuals in other personal and societal wellness sectors who are interested in gaining evidence-based insights through scientifically validated research."
"The platform helps designers think through research with simplicity and rigor. The essence of research is about people, tasks, sequence, and timing. ProofPilot enables research designers to coordinate all of these components into an optimal experience that balances the needs of both the science and the people involved," he explained.
"While many of the ProofPilot Rx customers might have significant experience designing and developing clinical trials, the software’s point and click interface enables trial-naive companies to create robust and valid research designs to test everything from skincare solutions to sleep behavior."
Ultimately, by simplifying the process, the ProofPilot platform is able to eliminate weeks and months of wait time: a typical database build takes about 10 to 12 weeks, plus all the fees incurred, for the build, whereas with ProofPilot, customers can create a protocol in about one day.
"This translates into the ability for customers who already do trials to do more studies, and for those who have never been able to engage in clinical trials before, because of small budgets, quick turnaround times, lack of regulatory experience, etc, access to develop the studies they have always wanted to do," said Amsden.
The company plans to use its new funding to both enhance the scalability and features of its platform, create support features for organizations that are new to research, and, finally, educate both life science and wellness markets about the new value our approach can bring to bear.
Along with the funding, the company also added two new members to its board of directors: Jeff Kozloff, the co-founder and former CEO of Verilogue, and Esther Dyson, executive founder of Wellville.
"Esther Dyson is one of our original investors. Prior to that, she was a participant in a ProofPilot trial. More recently, she’s sponsored a trial with her non-profit. So, beyond her years of visionary health leadership – her guidance, imagination, and network – comes with a real knowledge of what ProofPilot is, how it works, and what it could be. That kind of combination is really powerful," said Amsden.
ProofPilot's ultimate goal is to use its platform to help pharmaceutical and medical device companies scale their research capabilities and still make more room to explore the potential of digital health solutions, he explained.
"For the first time, health and wellness companies can now run clinical trials to substantiate their products and services at a manageable cost. Moreover, participants can seamlessly engage in a wide variety of research efforts outside of those focused solely on disease."
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