Cytel designed a Bayesian, externally controlled Phase III trial design that the FDA accepted for a novel anti-infection therapy.

A small biopharma needed a Phase III trial comparing a novel anti-infection therapy against historical controls across four pathogen subgroups, with no prior experience of Bayesian design or external control analysis. Cytel's strategic consulting team built optimized design options, an analysis methodology for externally controlled trials, trial simulations and protocol text, and supported the FDA Type C meeting. The page states an FDA-accepted design, a 33% reduction in patient enrollment and an estimated $2.4 million in savings.

Cytel is a biostatistics and clinical trial design firm whose East Horizon software is used by pharma sponsors for adaptive design, simulation and regulatory-ready statistical analysis

This sits in the Design & Stress-Test stage of the AI use-case lifecycle: Named examples from the tools pharma teams use to scope, prototype and benchmark an AI use case before committing to build it — data-catalog, sandbox and evaluation platforms.