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Phase 4 is the fastest-growing area of clinical research today. At an annual growth rate of 23%, industry investment in post-marketing research is expected to top $12 billion in 2007. Rampant growth in Phase 4 research should come as no surprise, however. A changing regulatory environment, growing concerns about the safety of new medicines, and various uses for large-scale, real-world data on marketed drugs' safety and efficacy are primary drivers of the growth seen in the Phase IV research environment today. Post-marketing research is an important element of commercialization that enables companies to expand existing markets, enter new markets, develop and deliver messaging that directly compares their products with the competition, and secure a niche position in crowded markets. What's more, payer groups and regulators are both requiring more post-marketing data from drug companies.

Given the increasing importance of post-marketing research, continued growth expected for Phase IV trials, and mounting competitive pressures, it is critical for companies to make full use of the information and data available to them. Mastering Phase IV Clinical Trials is a comprehensive post-marketing study management tool designed to provide industry executives with benchmark data and best practice information to inform key strategic and operational decisions in the areas of Phase IV:

• Trial management structure and oversight
• Research strategy
• Study design and execution
• Study timelines and cycle times
• Performance metrics and management
• Operational activities
• Trial budgeting and outsourcing
• Trial staffing

 

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