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This suggests a radical shift in thinking about the role of CROs in the drug development process, but one that is a natural outgrowth of the aforementioned general and industry-specific changes in the drug development environment today. |
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B. The Advantages and the Pitfalls of Contracting In |
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Under the right circumstances (as detailed in the next section of this chapter), a CRO may have a great deal to offer the drug development company, including |
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a broad range of clinical experience |
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multiple areas of therapeutic expertise |
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global resources and experience |
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an established research team |
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access to qualified investigators |
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the resources to start up studies faster |
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expanded development capacity |
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Drawing on these capabilities can give the drug development company not only more resources, but also more flexibility. The company can augment its own internal expertise to get the most effective mix of resources for a particular projectand it can change the mix as necessary to meet the demands of different projectswithout the tremendous costs of maintaining a huge, all-purpose organization in-house. The company could even contract in more than one CRO, virtual-corporation-style, if a particular project warranted bringing together complementary strengths from several different organizations. |
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Sure, the advantages sound hard to beat. But there are also potential risks to contracting in a CRO, including |
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loss of control over studies |
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inadequate CRO resources and expertise |
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late, inaccurate, or otherwise unusable results |
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incompatible corporate cultures |
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failures in communication |
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lack of rapport with key people |
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