As longtime cancer doctors with regulatory experience, Pi Health cofounders Geoff Kim and Bobby Reddy knew that completing clinical trials took far too long. There was the painfully slow process of signing up patients and after that a grueling slog through vast swamps of data to prepare voluminous regulatory filings–something that few hospitals and clinics can handle. The pair knew their startup’s best chance of success meant doing an end run around all that. So they did something audacious and unprecedented: they built their own cancer hospital in India.

Clinical trials are an enormous bottleneck in drug development, and Kim and Reddy thought the AI-enabled software they’d been building at Pi Health could help do them faster and cheaper by expanding the pool of potentially eligible patients. But the majority of clinical trials today are done in top-notch academic medical centers, and first they needed to prove that their AI-enabled software could help overseas hospitals and smaller community cancer centers handle the documentation required to get through regulatory approval. So they found a site in Hyderabad, a major technology and pharmaceutical center in southern India, and built a 30-bed, state-of-the-art cancer hospital.

Pi Health Cancer Hospital opened in September 2023, and began running clinical trials last year. It’s participated in eight so far, including one that helped lead to a drug for head, neck and lung cancer being approved in India just seven months after the first Indian patient was enrolled in the study. That’s less than half the time such a process would typically take and a major validation point for the software, one that Kim and Reddy believe will help them attract more customers.

“We are trying to do everything in our power to make this a much more efficient process,” Kim, the company’s CEO, told Forbes. “There are all these new and exciting ways to attack cancer. If we can do [the clinical trials] faster and cheaper and get therapies out to patients, we want to do it now because there are people waiting right now.”

Pi Health Cancer Hospital opened in Hyderabad in September 2023 and began running clinical trials last year.

Only 8% of cancer patients in the U.S. participate in clinical studies, in part because of the voluminous paperwork required to run them. That limits understanding of the disease and the way that it affects diverse populations, and also means drug approvals take longer and cost more than they would if the limited pool of patients weren’t a bottleneck.

“The clinical trial process is so confusing. It’s just alphabet soup.”

Pi Health’s software aims to lower the burden. It combines all clinical trial data into one place, streamlining workflows and reducing errors, starting with the trial design and continuing through regulatory submission. It uses artificial intelligence to check for discrepancies and errors in data and to produce automated notes with clinical documentation from regulatory-grade data.

To date, the Cambridge, Mass.-based startup has raised some $40 million at a valuation of nearly $100 million. It is generating revenue, with signed contracts of more than $70 million. And it is working on nearly 20 clinical studies for five global........

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