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Author:Bryde, D.J.
Joby, R.
Title:Product-based planning: the importance of project and project management deliverables in the management of clinical trials
Journal:R & D Management
2007 : SEP, VOL. 37:4, p. 363-377
Index terms:pharmaceutical industry
project management
R&D
product development
United Kingdom
Language:eng
Abstract: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.
SCIMA record nr: 267753
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