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insufficient capacity or personnel to handle a major increase in workload or a backlog of work |
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lack of special facilities to conduct key aspects of a new project |
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movement into a new therapeutic area in which internal staff has little expertise |
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B. Traditional Strategies for Contracting Out to a CRO |
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Once it is determined that a CRO can help in circumstances such as those described in the preceding paragraph, the sponsor must determine what strategy to pursue for using the CRO. Traditional strategies include |
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temporarily augmenting staff by hiring a CRO to help with a backlog or an increase in workload (for example, hiring additional monitors from a CRO to help internal monitor staff carry out an unusually large project) |
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farming out certain aspects of a study to a CRO that has the special facilities to handle them (for example, using a CRO with a purpose-specific lab to handle HIV-positive or other special-need samples for which the sponsor has no comparable facility) |
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using a CRO in areas in which the sponsor has little experience (for example, using a CRO with expertise in CNS studies to handle certain aspects of a schizophrenia study) |
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These are all traditional strategies that represent methods of contracting out, rather than contracting in. They may be characterized as follows: |
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Limited use of CRO resources. The sponsor hires the CRO to supply specific resources to meet a particular need, without regard to larger areas of experience or expertise offered by the CRO. |
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Central control at sponsor level. The CRO simply carries out the sponsor's directives, often with little or no access to information about the larger context in which the work is taking place. |
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Urgency often a primary basis for selection of CRO. The decision to use a CRO is based not on proactive planning for future needs, but on a reaction to an immediate crisis; the CRO may be selected largely, if not wholly, on the basis of who can start work sooner. |
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C. The Alternative of Contracting In |
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While traditional strategies continue to be perfectly adequate in certain circumstances, their value is becoming increasingly compromised by the general and industry-specific trends shaping the drug development environment. |
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As sponsor organizations continue to reorganize into leaner, less unwieldly, more flexible entities, their internal resources continue to shrink, making it |
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