Clinical Development

Need
• Mid-sized pharmaceutical company conducting large-scale pivotal trial for new trauma drug
• Patient enrollment far below target
• Prolonged time to market would jeopardize Company’s competitive position in the marketplace

Approach
• Reviewed project status to identify issues impacting patient recruitment
• Implemented strategic programs to train and assure compliance and consistency across the multiple ER Teams treating the patient
• Supported company in maintaining continuity and meeting timelines during multiple management changes
• Recommended revisions to case report form and patient management to meet enrollment targets
• Determined what factors and demographics contributed to successful patient recruitment and made recommendations to management to add investigative sites with desired profile; identified problem site organizational issues and successfully recommended solutions

Benefits
• Company mitigated downside of slow patient enrollment
• Completed study with data supportive of product registration