Outgrowing Excel: Implementing RTSM In A Live Phase I Trial

Transitioning a live Phase I oncology trial from manual spreadsheets to an automated system is often viewed as a high-risk maneuver. For lean clinical operations teams, the administrative burden of manual enrollment and drug supply workflows eventually hits a breaking point, yet the fear of disrupting patient care or site momentum often delays necessary upgrades. This real-world look at a mid-study RTSM (Randomization and Trial Supply Management) implementation reveals how a clinical-stage biotech successfully modernized their operations without hitting the pause button on their trial.

The transition highlights a focus on streamlined documentation and direct access to experts who understand the nuances of early-phase oncology. By prioritizing user experience and rapid response to protocol changes, the study team eliminated the six-to-ten-week delays typical of traditional system updates. Readers will discover how a focus on team continuity—keeping the same experts from the initial demo through go-live—removes the friction of re-education and ensures that the technology serves the trial, rather than the trial serving the technology.