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more and more difficult to handle all major project demands internally. The solution may be to look to a CRO not just to help out on the periphery of a project, but to join in with the sponsor as a partner in it, acting as a virtual extension of the sponsor's resources and capabilities. |
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In contrast to contracting out, the strategy of contracting in a CRO as a project partner may be characterized as follows: |
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Potentially extensive use of CRO resources. The sponsor may choose a CRO with a broad range of experience and expertise in planning, carrying out, and completing drug development projects, and exploit that experience and expertise throughout the project. |
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Decentralized control. In planning and managing resource, budgetary, and time requirements, the sponsor shares control with the CRO, providing ample information and access to enable the CRO to contribute to the decision-making process. |
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Performance as a primary basis for selection of CRO. Rather than choosing a CRO based on who can get the job started fastest at the best cost, the sponsor makes CRO selection decisions based on the CRO's track record of quality, speed, and dependable performance. |
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D. The Key Differences Between the Traditional View and the Alternative |
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Perhaps the best way to sum up the preceding material is to say that the difference between traditional contracting out and the alternative of contracting in is the difference between seeing a CRO as a back-up resource and seeing a CRO as a partner. Reactions to crises tend to drive the former; by contrast, proactive planning characterizes the latter. |
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| Tradition: The CRO as Back-up | Alternative: The CRO as Partner |  |
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In-house staffing based on expected workload |
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| In-house staffing based on core needs | |
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CRO used when in-house resources become inadequate |
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| CROs included in resource planning | | Crisis management atmosphere | |
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Proactive planning for CRO involvement |
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CRO viewed as back-up to in-house staff |
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CRO viewed as complement to in-house staff |
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| | Scope of CRO services used is limited | |
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Full resources of CRO considered for use |
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| | Major concern: time | Major concern: total performance | | Results often unfavorable | Results often favorable |
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