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Page 284
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[Clinical trials]
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multidisciplinary teamworking, 216
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multiple projects, 212-215
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quantity, quality, and timeliness, 210-212
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realism, 204-208
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role of senior management, 208, 215
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Commercial attractiveness of project portfolio, 31, 32
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Communication
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fostering communication channels in alliances, 153
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IT and, 265
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managing an international project team and, 104-106
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model for communication between sponsor and CRO, 184, 185
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Computer Aided New Drug Applications (CANDAs), 267
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Contracted clinical R&D, 161-186
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actions following proposal award to CRO, 176-181
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actions within the CRO, 176-179
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actions within the sponsor, 179-181
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approaches to selecting a CRO, 166-169
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communication model for sponsor and CRO, 184, 185
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essential steps taken when contracting out studies, 164-166
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preferred partnerships, 169-171
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preliminary budget proposals, 173, 174
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[Contracted clinical R&D]
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preparing a fully costed proposal, 174-176
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rationale for contracting studies to CRO, 162-164
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response by CRO to request for proposal, 172, 173
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virtual organization and increased use of CROs, 276
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when things go wrong, 181-185
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pharmaceutical company perspective, 181, 182
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project management within the CRO, 182-185
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Contract research organization (CRO). See Contracted clinical R&D
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Core team, 89-91
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Cost of development, 30, 31
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Cross-functional high-performance teams, 273-275
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project management and, 278
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Cultural concerns raised by portfolio review process, 47, 48
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Customized drug delivery devices, 188-189
D
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Decision trees, 35-37
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Defense industry
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control of projects, 83-100
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assessment of projects, 84, 85
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background and situation status, 83, 84
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critical success factors, 86
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framework of control, 92-97
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management of change, 85, 86
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organizational structure, 87-92
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outcome, 98-100

 
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