Clinical Development
Operations

Need
• Foreign specialty pharmaceutical company with flagship product for congestive heart failure
• Product licensed to major pharmaceutical company with commercialization contingent on reaching development milestones
• Patient enrollment lagging projections; timelines in jeopardy

Approach
• Reviewed protocol and interviewed investigators; recommended protocol amendments to expedite patient enrollment
• Provided guidance in understanding U.S. regulatory environment and major pharmaceutical company requirements
• Modified data capture points on the case report form and proposed patient capture strategy to enhance recruitment
• Assessed enrollment by site and country; conducted feasibility analysis to identify investigators with capability to achieve enrollment target; added new countries/sites to study; functioned as liaison in establishing communication lines and providing stability for investigator sites
• Recommended clinical organizational changes with centralized management and reporting methodologies to rapidly identify and resolve issues with the potential for impacting project timelines
• Provided technical support and documentation to facilitate transition of product to licensee

Benefits
• Project completed within timeline to achieve satisfaction of critical development milestone
• Pivotal data obtained to support commercialization with value creation for sponsor and licensee