Unicorner on Faro: Why the Protocol Is the Real Bottleneck in Clinical Development

Faro was featured in the September 21 edition of Unicorner, a weekly newsletter that profiles one startup per issue. The piece, titled "Solving the human bottleneck of biotech," argues that much of what slows new medicines on their way to patients happens before the first patient is enrolled, in the design decisions and documentation behind every trial.

The article traces Faro's origins to our CEO Scott Chetham's early work as a trial coordinator and investigator in Queensland, Australia. After moving into industry, he kept seeing protocols that placed more burden on patients and sites than they could realistically carry. "I got sick of constantly telling teams, by the way, this protocol you've designed is infeasible," he told Unicorner.

Unicorner's analysis puts numbers to that problem. Protocol writing was the single largest specific cost item in investigator sponsored trials, at a median of 7.2% of total trial cost, and a review of 21 Phase III protocols found a median direct cost of $535,000 to implement a single amendment. The article also points to overly narrow eligibility criteria as a leading cause of recruitment failure, which is a decision made at the protocol stage.

Faro addresses these problems by converting protocol design elements into structured data that AI agents can reason over. Faro Designer captures each design decision and the intent behind it. Faro Optimization evaluates the design against benchmarks including the Tufts CSDD framework to estimate patient burden, site burden, and cost. Faro Authoring generates documents from the same structured foundation. A human reviews and signs off on every recommendation.

Six of the world's ten largest pharmaceutical companies now use Faro, and in August 2026 we closed a $37.3 million Series B led jointly by Merck Global Health Innovation Fund and S32.