Adaptable By Design: RTSM That Absorbs Protocol Change Through Configuration, Not Code

Small system enhancements after go-live add risk, cost, and interruption to trials that are already enrolling. This fireside chat features Luis Vargas, a sponsor-side IRT specialist at Genmab with 12 years in the field (eight on the vendor side), and Fiona Geiger, who leads account and project management at Endpoint.

They discuss a joint approach to RTSM design in which likely protocol changes, from cohort and dose-level decisions to local versus central supply, are anticipated and tested before the study starts. The conversation covers how stakeholder requirements were gathered with the future in mind, how phase one and phase three needs differ, and how success was judged. A live Q&A addresses the upfront effort involved.

Watch the session to hear how the partnership shaped the approach.