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majority of companies across all industries have not achieved the expected business benefits from implementing ISO 9000. They are mostly forced to implement it because it was expected by their customers. Management must have clear objectives as to the improvements sought and the means to monitor these improvements, rather than using any quality system just for public relations or enhancing credibility. |
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1.
Procedures for Projects |
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There is one further SOP which does not seem to appear in any pharmaceutical company's register. This should cover project management methods. Examples of its content would be how project managers are appointed, how their authority (or empowerment) is defined, their responsibilities, the stages of setting up and running a clinical trial projectin fact, all the areas discussed in this chapter and many more. |
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Many companies will have such a document for running drug projects at the strategic levelindeed, this is the level at which the discipline is most advanced. However, it will be more difficult to achieve top level objectives if individual smaller projects, clinical trials and many others, are not managed effectively at the operational level. Thus, the clinical project manager has the tough job of ensuring good communication with other levels of management. It is hardly practical for strategic project managers to track all the tasks in every individual project, so agreement has to be achieved as to which key stages will provide the interface links to enable effective whole drug project tracking. Suitable stages would be best defined as deliverables, such as the approved protocol for a pivotal phase III trial or its final report. |
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F.
Getting Things DoneThe Clinical Project Manager's Authority |
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At several stages in this chapter, the project manager's vital need for top management support has been emphasized. If this one need were satisfied, many companies which are now average performers, would be among the leaders in their fields. This is graphically illustrated by a survey carried out in 1994 [5]. Fifty chief executives from U.K. pharmaceutical companies were approached by letter to participate. The subject was top management's attitudes toward critical issues in delivering clinical trial results on time. In return for a brief interview, the participants were offered free consultancy to assess their current clinical project systems and to suggest changes. What is significant about the survey is not how many responded (four), but that the vast majority immediately delegated the matter to their |
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