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Page 161
7
Managing Contracted Clinical Research and Development
The View from the Client and Contract Research Organization
Frank R. Mangan
F.R.M. Associates Consulting Services
Surrey, England
Albert J. Siemens
ClinTrials Research, Inc.
Research Triangle Park, North Carolina
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I. Rationale for Contracting Studies to Contract Research Organizations (CROs)
162
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II. Essential Steps to be Taken Within a Pharmaceutical Company When Deciding to Contract Out Studies
164
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III. Approaches to Selecting a CRO
166
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IV. Preferred Partnerships
169
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V. Response by CRO to a Request for a Proposal
172
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VI. Preliminary Budget Proposals
173
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VII. Preparing a Fully Costed Proposal
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