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solid core. These outside parties can include just-in-time resources, consultants, suppliers, and partners, like CROs. |
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Handy positions the doughnut, with its flexible open space around the core, as a useful alternative to the traditional, rigid organizational chart that has historically defined corporate structure. |
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B. Personnel: Developing New Skills |
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When a company is working closely with a CRO, the personnel it assigns to the project frequently need to develop skills that they may not have been called upon to utilize in their current positions. |
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For instance, in the sponsor-CRO relationship, a CRA at the sponsor company moves from actively doing the tasks to managing people at the CRO who implement tasks under the CRA's direction. Similarly, research physicians may be communicating concepts to their CRO counterparts, who then develop the protocols and manage day-to-day patient safety issues. |
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Often, the person at the sponsor company is expected to manage the study at one or two levels higher than those to which they were previously assigned. They may be paired with personnel at the CRO who need advice and direction that they are not normally asked to provide. The CRO personnel may in fact even have more experience in the project than the sponsor personnel who are providing them with direction. |
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To avoid potential problems in this area, sponsors would do well to choose for close work with CROs those people who have previously shown skills or aptitudes in the Cs: conceptualizing, coordinating, consolidating, and communicating. Furthermore, they should make sure that these people understand what is expected of them and that they have the resources they needtraining, mentoring, or other programsto develop these skills fully. |
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C. Procedures: The Best of Both Worlds |
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It is important to keep in mind that there exists a fundamental difference in the way a sponsor's development team functions operationally and the way a CRO development team does, since one works in a single-client environment and the other works in a multi-client environment. |
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In the sponsor team's single-client situation, it is possible to develop unified SOPs and to standardize many aspects of the drug development process across various therapeutic groups and projects. In the CRO's multi-client environment, on the other hand, SOPs and systems must be much more flexible, since they must deal with a wide variety of unique client environments. |
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How can the sponsor and the CRO bridge the gap created by this situation? It may seem like a simple either/or proposition: either the CRO duplicates the |
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