How do you successfully manage a controversial large-scale project from the ground up through the entire operational life-cycle? As a biotech focused CRO ProTrials effectively partnered with the sponsor during the early stages of the product’s clinical development (Phase 2) and supported it for eight years through Phase 3 analysis. With the eyes of the public health world on this groundbreaking study, ProTrials participated in every aspect from study design, implementation, project management, subject recruitment activities, monitoring, and the development of critical subject retention strategies. We were able to appropriately staff the project with experienced and flexible staff to ensure that goals and milestones were met. ProTrials used exceptional communication skills and effective tools to adeptly handle the complexities of frequent press activities and highly public community relations associated with this study.