Having designed clinical trials and authored study protocols for more than 20 years, Scott Chetham has a basic frustration with the field.
“People are always surprised that everything is done in Microsoft Word,” he said, but it’s a universal practice in his experience: No matter how complex or meticulous the trial, clinical scientists are still drafting trial protocols as Word documents and sending numerous versions around before locking them in as PDFs.
The frustration was what led Chetham to start Faro Health in 2019 after taking a sabbatical from his former job as head of clinical operations at Verily. And it’s drawing General Catalyst into a new $20 million funding round, which also involves existing investors Section 32, Polaris Partners, Zetta Ventures and Northpond Ventures.
Chetham is not alone in wanting to shake up how clinical trials are planned and run. In recent years, companies like ConcertAI, Medable or even Chetham’s former employer, Verily, have raised significant money to develop new technologies that promise to make trials cheaper, faster and more diverse, albeit each with slightly different focuses.
Faro’s main offering is a software researchers can use to create a clinical trial protocol from scratch — and visualize what each additional element, whether it’s a screening criterion, an assessment or an outcome measurement, means for a day in the life of a patient and a trial site.
With real-world data aggregated from various sources, the platform also provides real-time feedback on factors such as time, cost and feasibility, said Chetham, the CEO.
The ability to play with different variables — down to the exact type of blood chemistry panel used to measure a biomarker — is key, Chetham said, as clinical trials now capture an increasing amount of information through more and more testing.
Chetham noted that Faro has been signing on customers much faster than he expected, which he suspects has something to do with the current biotech funding crunch.
“We’re hearing from customers that they have to do a lot more trials with less money,” he said, adding later: “We really help them make very critical decisions early on, versus waiting until it’s too late and then amending and changing it — because if they need to, as I said, these mistakes are very expensive later on to fix.”
The new funding will go toward scaling the company so that Faro can take on more customers, including those in Europe. At this time last year, Chetham had put together a team of 20, comprising clinical trial experts and software engineers spread across San Diego (where Faro is headquartered), San Francisco, the East Coast and Europe. It plans to double in size in 2023.
Elena Viboch, partner at General Catalyst, will become a board member of Faro.
Faro Health Inc. Announces $18.3M in Seed and Series A Funding to Digitize Clinical Development to Transform Clinical Protocol Design
Faro, the clinical protocol solutions company, announces the closing of a $15 million Series A financing, led by Section 32, with additional participation from Northpond Ventures, Polaris Partners and Zetta Ventures, to accelerate its go-to-market efforts. Faro’s cloud platform helps teams collaboratively design clinical protocols that balance the scientific needs of complex clinical development with the key drivers of performance, feasibility and patient centricity.
“Faro’s platform empowers the design of more intelligent clinical trials that master the operational complexities inherent in modern trial designs, are more patient centric in their approach, and reach milestones faster,” states Scott Chetham, Ph.D., co-founder and CEO of Faro. “Finding investment partners like Section 32 has been a key success factor for us at Faro. Section 32 has expertise in the complexities of clinical trials and is a terrific partner to have alongside us as we drive the digital transformation of clinical development.”
High and rising protocol design complexity is the inevitable consequence of biopharmaceutical companies pursuing more ambitious clinical development programs. Increasing investments in rare disease, immuno-oncology and efforts to stratify patient subgroups, the use of genetic data or biomarkers, increasing use of structured and unstructured patient data from multiple sources; are all continuing to drive more complex clinical trials. The mean number of patient procedures performed during a phase II or III trial is now 263 supporting a mean of 21 and 19 total endpoints respectively. Given the inverse relationship between complexity and every metric of clinical trial performance, new tools – many that have been introduced during the coronavirus pandemic- are required to drive development speed, efficiency, and quality.
Faro’s cloud platform addresses the operational problems and delays caused by the traditional word processing and spreadsheet driven method of clinical protocol development. Software assisted design of the Schedule of Activities powered by standardized study activities and relevant metadata provides real time actionable insights into critical performance and quality metrics during the clinical protocol development process. This ensures teams can collaboratively make informed decisions about the impact of every study activity and its associated measurement. Protocol optimization algorithms provide Intuitive recommendations to assist teams to adopt modern decentralized approaches. With visualizations of the patient journey always available, teams can focus on developing protocols that are more inclusive and patient centric in their design.
Faro redefines how clinical protocols are developed by connecting all the stakeholders in the clinical trials ecosystem, including sponsor and CRO ClinOps teams, research sites, vendors, patients, and laboratories through a single software platform. The Faro platform provides a best in class standardized library of study activities that has been augmented with performance related metadata to provide intuitive insights during protocol development. Faro brings transparency, trust and predictability to protocol development through detailed analysis of the impact of each study activity, ensuring teams have the optimum protocol design for operationally complex trials. As a result, clinical protocols developed using Faro’s platform are operationally efficient answering the right questions in the least burdensome way for patients, payers and regulators.
Sponsors, CROs, and researchers can learn more by visiting www.farohealth.com and requesting a consultation with a Faro solutions expert.
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