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The Role of Clinical Research Organizations in Drug Development
Albert J. Siemens
Clin Trials Research Inc.
Research Triangle Park, North Carolina
James E. Higgins
Health Decisions, Inc.
Chapel Hill, North Carolina
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I. Challenges Faced by the Pharmaceutical Industry
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II. Responses to the Challenges
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III. Enter the Clinical Research Organization (CRO)
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A. CRO Definition
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B. CRO Origins
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C. Multinational Expansion
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D. Rationale for Using CROs
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E. Preferred Supplier Relationships
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F. Keys to Success
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IV. Project Implementation
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A. Data Retrieval and Review
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B. Capture and Transfer of Data Generated Outside the Clinic
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C. Access to Data
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D. International Databases: Integration of Data
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E. Support for Regulatory Filings and Marketing Efforts
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V. Concluding Observation
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References
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