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制药项目管理,药物与药学 387条(本栏目收费,不能显示细节,电话13136136841)
special challenges of clinical research projects, 204-216
204 216
clinical trial risk management, 212
212
managing risk, 208-210
208 210
multidisciplinary teamworking, 216
216
multiple projects, 212-215
212 215
quantity, quality, and timeliness, 210-212
210 212
role of senior management, 208, 215
208 215
Commercial attractiveness of project portfolio, 31, 32
31 32
fostering communication channels in alliances, 153
153
managing an international project team and, 104-106
104 106
model for communication between sponsor and CRO, 184, 185
184 185
Computer Aided New Drug Applications (CANDAs), 267
267
Contracted clinical R&D, 161-186
161 186
actions following proposal award to CRO, 176-181
176 181
actions within the CRO, 176-179
176 179
actions within the sponsor, 179-181
179 181
approaches to selecting a CRO, 166-169
166 169
communication model for sponsor and CRO, 184, 185
184 185
essential steps taken when contracting out studies, 164-166
164 166
preferred partnerships, 169-171
169171
preliminary budget proposals, 173, 174
173 174
[Contracted clinical R&D]
preparing a fully costed proposal, 174-176
174 176
rationale for contracting studies to CRO, 162-164
1621 64
response by CRO to request for proposal, 172, 173
172 173
virtual organization and increased use of CROs, 276
276