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| Tekijä: | Bryde, D.J. Joby, R. |
| Otsikko: | Product-based planning: the importance of project and project management deliverables in the management of clinical trials |
| Lehti: | R & D Management
2007 : SEP, VOL. 37:4, p. 363-377 |
| Asiasana: | pharmaceutical industry project management R&D product development United Kingdom |
| Kieli: | eng |
| Tiivistelmä: | As the cost of clinical trials (hereafter as: c-trials) continues to rise, many pharmaceutical companies outsource the management of c-trials to clinical research organizations on a fixed-price contract basis. In this paper, an alternative approach based on the concept of Product-Based Planning is presented. Key elements of the approach are the creation of a deliverables (as: dlbs.) budget and the establishment of project management-related dlbs. The conceptual developments described are supported by a telephone survey of 10 U.K. practitioners, confirming the prevalence and limitations of fixed-price contracts, while highlighting a willingness to try a dlbs.-based approach. The key barrier for implementing a new approach is resistance from key stakeholders etc. |
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