Launching a medical device clinical trial for a U.S.-based sponsor in a different global region requires more than regulatory approval and site selection. It requires practical coordination across sponsor teams, local site leadership, investigators, monitors, vendors, and study operations teams. Through a case study approach, panelists for this session will examine the start-up of a multisite medical device study in Saudi Arabia, from feasibility and site qualification through site initiation, activation, screening, and early enrollment. Panelists will discuss what worked, what required adaptation, and what clinical operations teams should consider when executing studies across geographies, cultures, time zones, and healthcare systems. Attendees will leave with practical lessons on site readiness, communication cadence, role clarity, patient recruitment, issue escalation, and sponsor-site collaboration in global medical device trials.

CEU: 1.0 ACRP

Speakers:

• Muath AlGhamdi, Clinical Research Specialist, Trial Forward

• Ryan McFadden, Lead Clinical Research Associate, Dexcom Inc.

• Kunal Sampat, Founder & CEO, Trial Forward