Clinical research is often seen as a risk-averse industry, but is that perception accurate? This interactive session challenges the assumption that traditional choices are inherently safe. Through real-world case studies and a behavioral risk framework, we’ll explore how decisions around protocol design, site selection, technology adoption, and feasibility often mask high operational risk under the guise of caution. Attendees will examine how “playing it safe” can lead to protocol amendments, recruitment failures, and delays, and learn how to use Quality by Design (QbD) and ICH E8(R1) principles to anticipate and mitigate these outcomes. The session includes audience polling, risk-mapping exercises, and practical tools to identify where organizations may be unintentionally risk-seeking. Whether you’re in study startup, clinical operations, or site management, you’ll walk away with actionable strategies to reframe risk, support better decision-making, and challenge the illusion of safety that drives costly inefficiencies in clinical trials.

CEU: 1.00 ACRP

Speakers:

• Mitchell Hilbe, CEO / Co-Founder, DiversiTrials

• Jess Thompson, CEO, Clinical Research Pro

• Jami Walker, Clinical Operations and Management, Mead Johnson