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VIII. Actions Following Proposal Award |
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A. Actions Within the CRO |
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B. Actions Within the Sponsor |
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IX. What to do if it All Goes Wrong |
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A. The Pharmaceutical Company Perspective |
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B. Project Management Within the CRO |
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References |
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I.
Rationale for Contracting Studies to Contract Research Organizations (CROs) |
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In the last ten years, the CRO industry has changed dramatically. During the 80s, pharmaceutical companies used CROs, primarily, as a last resort to implement studies or selected portions thereof, which had been fully planned and organized by the sponsor. Often, the studies were not pivotal. The services contracted could be restricted to selecting and/or initiating study sites, clinical monitoring, or, perhaps, checking case report forms, entering data, or writing a report. The CRO was seen as the agency you turned to when the pharmaceutical company no longer had internal capacity or could not cope with competing requirements, and were very much a last resort providing a short-term solution. In fact, many CROs came into existence through this type of approach by the pharmaceutical industry specializing in data management or clinical monitoring by the very nature of the experience and expertise of their founders [1]. |
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Cost containment measures brought about by health care reforms in the U.S.A. and Europe have resulted in major restructuring within the pharmaceutical industry as executives have responded to the challenges of maintaining the high profits enjoyed throughout the 80s. Many senior pharmaceutical executives are recognizing the synergy which can exist between their company and the CRO industry. Following mergers and acquisitions, downsizing has been very attractive but, in many cases, has led to staff insufficient to cope with the workload. Using a CRO can help a pharmaceutical company manage peaks and troughs in the development cycle without adding more people to the payroll. The next logical step is to consider outsourcing as part of strategic planning, moving the responsibility and risks of hiring, housing, and supporting staff from the pharmaceutical company to the CRO. Consequently, the large fixed costs of clinical development can, then, be managed as variable costs allowing pharmaceutical executives |
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