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In addition, the nature of the activities undertaken in project teams is especially complex because |
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scientific, medical and commercial knowledge is constantly changing and much of the work in R&D takes place at the leading edge. |
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people with different expertise need to be integrated into the core project teams. They also need to undertake pivotal roles at interfaces between the core team and other departments and functions. The exercise of these pivotal or interface roles is difficult and often poorly executed. |
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the nature of these projects is highly dynamic, affected increasingly by go/no go decisions caused by rapidly changing data. As the need for speed increases, the turnover in project terms increases with ever shorter time for teams to form and perform. |
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teams are frequently split geographically with difficult communications |
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- at either ends of long winding corridors, |
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- at either end of large acreage sites, |
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- at multiple sites in the same country, and |
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- between countries. |
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cultural differences, often as a result of merger/acquisition across international boundaries, highlight the issues of consistency and standards and process/reporting variations. |
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Cross-functional teams also need to include people beyond the direct scope of development. Traditionally, only clinicians have been involved. Cooperation with manufacturing at an early stage is becoming increasingly important to obtain faster review times combined with the possibility of new stability guidelines from the ICH (International Committee of Harmonization). Compliance with the new guidelines will require forward planning of production scale-up and methods and, thus, a need for earlier and more extensive manufacturing involvement. Traditionally, advance planning has not been a prime concern of manufacturing personnel who are more attuned to the daily issues of production runs and capacity. |
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Globalization is a growing trend in all industries and commercial sectors as the search continues for more effective use of resources and as communication of information across geographical boundaries becomes less of a |
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