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Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management

Cutting Edge Information, July 2011, Pages: 197


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Whether building a better product profile, establishing comparative effectiveness or accomplishing any number of other objectives, post-marketing research grants companies a range of clinical and commercial benefits. Amid rigorous payer demands and competitive pressures, Phase IV studies are a growing necessity - but they often remain deprioritized and under-resourced as teams struggle to marshal needed support for both strategy and execution.

Use this study to reinforce Phase IV research and perfect study management. Examine benchmarks for US and EU data across major therapeutic areas and five trial types:

- Integrate study planning and execution: Explore real-company structures as you work to maximize expertise and dissolve communication blocks. Clarify roles so that Phase IV objectives receive adequate attention.

- Win resource support: Match your needs to trial size and scope - compare planned versus actual spending and peruse staffing tables for 51 real- world Phase IV trials. Track per patient budgets and headcounts by trial type, geography and company size. Along the way, learn strategies for balancing outsourcing with in-house capabilities to ensure consistent trial support and top performance.

- Accelerate the trial timeline: Track timing using data broken down by study types, geography and nine key trial activities.

- Measure performance: Discover the metrics top companies use to track performance and drive improvement in their Phase IV operations.

QUICK SUMMARY
- Report Features
- Table of Contents
- Key Metrics
- Sample Content
- Charts and Graphs
- About CEI

TOTAL NUMBER OF SURVEYED COMPANIES
- 24+ Pharmaceutical, Biotech, Medical Device Companies and CROs

METRICS AND CHARTS
- 173 Charts and Tables
- 500+ Metrics


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