Protocol Design That Holds Up at Start-Up

About this session

In highly outsourced trials, sponsors remain accountable for start-up timelines, yet the protocol is rarely stress-tested for operational feasibility. While most protocols are vetted for scientific and regulatory soundness, they often underestimate the burden placed on patients and sites, leading to inevitable enrollment delays, deviations, and costly amendments. This session examines how to re-engineer protocol design through the lens of sustainability. We will explore how evolving regulatory expectations create an opening to address patient and site burden earlier, while the design is still easy to change.

Speaker

• MB

  Maria Bowen

  Head of Protocol Excellence, Clinical Science · Daiichi Sankyo

  Speaker