This session will explore the current landscape of protocol amendments and the growing operational, regulatory, and financial burdens associated with frequent changes. Through real‑world examples and industry data, we will highlight the key challenges that disrupt timelines, increase deviations, and strain site and sponsor resources. Attendees will engage in discussion around practical, scalable solutions that can streamline processes and reduce inefficiencies. By the end of the session, participants will leave with strategies to improve amendment planning, execution, and cross‑stakeholder collaboration.