TECHNOLOGY

Building On The Surge In Real-World Data, Crescendo Health Launches To Accelerate Clinical Trials

By Heather Landi

Crescendo Health nabbed US$3.4 million in seed funding to bring innovation into medical research by unlocking traditionally siloed health data.

The San Francisco-based startup built a real-world data platform and works with clinical research partners like biopharma companies, medical device manufacturers and contract research organizations to provide the tools and support required to collect and integrate information from patients’ routine clinical care. Crescendo Health partners with researchers to get informed consent from study participants then collects all of their longitudinal data from their providers, payers, electronic health records, pharmacy claims and even previous clinical trials.

The company collected an initial investment from early-stage investors including Define Ventures as well as other founders and executives to scale up its work.

Co-founded by veteran healthcare executives Sam Roosz and Michael Glassman, Crescendo Health aims to expand the information available to researchers beyond what’s gathered in the four walls of the research clinic. “We are working towards a future where research is seamlessly integrated with routine clinical care, making participation easy and accessible for patients from all backgrounds,” Roosz said.

Clinical research sponsors typically struggle to gather information from study participants beyond the limited points of contact that occur during a study. This leaves out critical data from participants’ other encounters with the healthcare system, including information from primary care or emergency department visits, lab tests and pharmacies.

“If you’re participating in a study at UCSF, the purview that they have into your healthcare and outcomes is kind of like looking through a peephole of just what they can see as you’re within those four walls of UCSF. And yet, the whole health journey of a patient is so much more than that,” Roosz said in an interview. “You may be receiving concurrent care at Stanford, at Sutter Health, at Kaiser and going to urgent care across the country while visiting family. And all of those insights are tremendously valuable for the course of research and yet, the way that we’ve designed our systems today, those insights are not readily accessible.

“We’re bridging that gap so that folks who are sponsoring research are able to do so more efficiently in a way that places less burden on sites, on patients and ultimately delivers more robust insights for folks who have that data at the end of the day,” he said.

A molecular biologist by training, Roosz initially met Glassman at the Stanford Graduate School of Business. Glassman went on to lead product management at Grand Rounds, which merged with Doctor On Demand to form Included Health while Roosz co-founded Datavant, a data company that eventually merged with Ciox in a US$7 billion deal.

The two teamed up for their next act to develop Crescendo Health with the goal of providing researchers with more longitudinal, comprehensive patient data. The company brings innovative digital health technologies to clinical trials, helping sponsors advance therapeutics in more efficient and cost-effective ways, according to executives.

The company’s business model benefits from major regulatory tailwinds that have helped open up access to health data, Roosz noted. The 21st Century Cures Act went into effect in 2021 as a national policy requiring healthcare providers to give patients access to all of the health information in their electronic medical records “without delay” and without charge.

“Health plans, Medicare, Medicare Advantage, Medicaid federally funded exchange plans and certified EMR vendors now have to create API access for patients to be able to access their data from those sources in a timely fashion and to put it in a third-party application of their choice,” he said.

Crescendo Health’s model works by garnering informed consent to collect health data on behalf of people participating in clinical research. Crescendo Health collects this information through APIs, data partnerships and other methods, converting those data into a format that’s accessible to patients and useful for researchers.

One distinction between Crescendo and other real-world data startups is that it incentivizes clinical trial participation by making all of the data it collects and curates for researchers available back to patients in the form of their personal medical records.

Another unique distinction: Crescendo is a public benefit corporation, which is a corporation created specifically to benefit the public in some way. According to the company’s website, Crescendo’s status as a PBC is a legal structure that enables the company “to make decisions that prioritize societal impact and the people we serve.”

The company has completed validation studies demonstrating the effectiveness of its model in partnership with life science organizations, including a top three contract research organization that conducts thousands of clinical trials each year, according to the company.

Clinical research sponsors can leverage Crescendo Health’s model to support a variety of use cases, including health economics and outcomes research that reflects the whole patient journey including the true costs of their care, postmarketing observational studies or safety registries that reduce the burdens placed on sites and patients, while also reducing costs for sponsors and longer-term follow-up or observational extension studies that help researchers understand the impact of interventions over time, according to executives.

Glassman and Roosz’s long-term goal is to scale the use of real-world data in clinical trials and the company’s services throughout the life sciences industry

“As we look over time, we fully expect that every single study that’s being run is going to be using real-world data as a component of the evidence capture and supportive clinical operations. Not only is Crescendo Health making that case, but we’re also seeing guidance that’s coming from regulators that are highlighting that ability to combine the randomization benefits and prospective research with the breadth, longitudinally and efficiency benefits of real-world evidence,” Roosz said.

As more trials move to decentralized formats and competitive pressure builds to bring therapeutics to market faster and cheaper, Crescendo Health has an incredible opportunity to power a new era of clinical research, said Lynne Chou O’Keefe, managing partner at Define Ventures.

“Crescendo Health is pioneering a new way of using real-world data to support clinical trials and envisions a future where life sciences organizations don’t have to rely on buying large data sets to support ongoing research,” Chou O’Keefe said.

https://www.fiercehealthcare.com/

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