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Clinical TrialsQuantum Leap or Last Gasp?
How Clinical Trials Can Make or Break a Drug Development Program
Leslie B. Rose
Medical Scientific Services Ltd.
Salisbury, England
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I. Are Clinical Research Projects Really Different?
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A. RealismClinical Research's Holy Grail
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B. The Role of Senior Management
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C. Predicting the UnpredictableManaging Risk
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D. Quantity, Quality, Timeliness
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E. Clinical Trial Risk ManagementA Summary
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F. Getting More from LessMultiple Projects, Priorities, Workload, Progress Control
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G. Progress InformationCan We Believe It?
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H. Senior Management Revisited
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I. Multidisciplinary Teamworking
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II. A New World of Clinical Research
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A. Projects versus HierarchiesNew Solutions
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B. Consistent Planning
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C. New Approaches to Written Procedures
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D. The Quality Dimension
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