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the Global Revolution begun to alter the shape of our vast arenas of business and industry, ushering us into the twenty-first century. |
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The effects of the Global Revolution reach into virtually every area of business and industry today, including health care and medicine. The process of drug development is no exception; in fact, it profoundly exemplifies the radical shift from the highly structured, largely self-contained corporate entities of recent history to the increasingly global, essentially boundaryless virtual corporations engendered by the Global Revolution. |
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This tempest of change presents immense challenges to those who are involved in developing new drugs today. The following material is intended to help by providing a better understanding of the forces at work, a clearer view of their effects, and, most importantly, some practical advice for successfully maneuvering through this strange maze in which we find ourselves, particularly with regard to the rise of CROs as a significant force in the new drug development environment. |
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A Note on Terminology For purposes of this discussion, we define a CROor contract research organizationas an entity that provides drug development companies with services that those companies traditionally have done in-house. |
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II. Defining the Landscape: General and Industry-Specific Trends Affecting the Drug Development Environment |
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A. The Effects from Without |
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The ever-increasing sophistication of technology in communications, transportation, and other areas that enable us to connect with each other across geographical and other boundaries has served to make those boundaries less meaningful in business and industry today. After all, if you can fax or fly to France on a moment's notice, what does it matter if your factory is in San Francisco? |
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In a world in which physical boundaries mean less, the traditional structures of business and industry make it more difficult to compete. The corporate model of a self-contained, closed entity, its unique culture, standards, and procedures guarded zealously against intrusion, no longer suffices. In a world in which people, information, and resources move more quickly than ever, the traditional structure is inherently slow to react. In a world of global opportunity, this structure is isolated and unconnected. In a world of rapid change, this structure is inflexible and rigid. The strength and permanence that were its attributes in another age are now its weaknesses. |
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