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Clinical Operations: Benchmarking Per-Patient Trial Costs, Staffing and Adaptive Design
Cutting Edge Information, April 2011, Pages: 170
Ensure trial success with cost and resource data, operations benchmarks and insight into adaptive design
The current patent cliff, shrinking pipelines, and the impact of a global recession place heightened pressure on the clinical development landscape. As competition intensifies for investigators, sites and patients, trial costs have reached unprecedented levels, causing drugmakers to adopt a bottom-line perspective and demand greater R&D efficiency. Greater efficiency leads to cost- and time-savings that could mean the difference in beating the competition to market and adding time to a drug's lifecycle.
Successful teams win this race by minimizing risks, eliminating trial unknowns and hitting study deadlines. Supported by ample resources, they build process improvements through performance measurement and charge ahead with new techniques to accelerate trial timelines.
Designed to benefit teams and individuals in any role in the clinical trials space, this study will help teams achieve clinical operations efficiency and realize the significant payoffs that accompany successful drug development:
- Save time through adaptive trials: Learn how leading-edge companies use adaptive design to accelerate trials and achieve the desired endpoints. Understand the FDA's new guidance and get a real sense of where the industry stands on this new frontier.
- Track the right metric at the right time: Track 26 operational, timeline and resource metrics across the five development stages using real-company data from 80-plus trials. Learn how to incorporate forecasting software into trial design and planning.
- Benchmark and manage resources: Break out individual costs and compare per-patient investments across five major therapeutic areas for Phases 1 through 4. Track staffing trends and coordinate in-house and outsourced teams.
Companies Included in Report:
- 21 pharmaceutical companies
- 12 biotechnology companies
- 9 medical device companies
- 23 contract research organizations
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