TG Therapeutics Streamlines A Complex Phase 2 RTSM Build With Korio

Some protocols pack the logic of several studies into one. A Phase 2 trial in generalized myasthenia gravis did just that. Participants started with an induction period, then moved into either blinded randomized treatment or open-label treatment based on their response, and a planned mid-study shift would change their paths again. The randomization and trial supply management (RTSM) system had to support every one of those turns while keeping the blind intact. For a lean biotech team facing a fixed first-patient-in (FPI) date, the real question was how much of that configuration work would land on their desks.

This case study shows how TG Therapeutics and Korio kept the build on track. A service team that knew both the protocol and the platform answered questions on the spot, absorbed protocol changes without moving go-live, and delivered a site interface that is simple and fast. Read on to learn how to keep a complex RTSM build from consuming your team’s startup capacity and putting your FPI date at risk.