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product development is carried out in the United States, Europe, and Japan, including the use of CROs. |
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D. Rationale for Using CROs |
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In the early years of the evolution of CROs, pharmaceutical companies often contracted out work that represented a narrow scope or was of a small scale; if the contracted job was of greater magnitude, it was likely considered to be of secondary importance, such as studies to support product launch or marketing, product line extension, or the development of a secondary indication. This practice was potentially a reflection of the lack of confidence sponsors had in the service providers at the outset. On the far end of the spectrum some product development managers contracted out the most difficult projects either in the hope of capitalizing on the specific capabilities and expertise of the selected CRO or, in the worse case, to avoid criticism in the event of failure had the project been handled by the company's internal resources. |
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During the late 80s and early 90s, pharmaceutical sponsors often enlisted the support of CROs upon encountering a crisis that may have resulted from unanticipated delays in study conduct due to a variety of internal or external factors, inadequate resource planning, or poor program management. Over the past few years, however, the crisis mode has largely been replaced with much more reasonable proactive planning to involve a CRO, whether the project is of top or secondary priority. Pharmaceutical companies have determined that CROs are a valuable, flexible source of qualified resources and specialized expertise and often can increase the speed of project performance. Most importantly, the use of CROs helps manufacturers to control R & D expenditures, particularly as outsourcing represents a variable rather than a fixed cost. |
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Pharmaceutical companies have now wholeheartedly incorporated the CRO into product development programs from R & D planning through product licensing, Phase IV trials, postmarketing surveillance, and outcomes research. This maturation has occurred most rapidly in the United States, but the same phenomenon is now also seen in Europe, Australia, and other countries that require country-specific trials as a prerequisite for product registration. As noted above, progress is being made in Japan as well. |
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The evolution of biotechnology companies has occurred almost coincidentally with the development of CROs. As those companies have generally been research-based, having little or no clinical development expertise or plans to develop the capacity, they have benefited greatly from, and contributed substantially to, the sophistication of CROs. Indeed, those biotechnology companies that have elected not to develop products through a licensing arrangement with pharmaceutical firms, have virtually depended on CROs exclusively, par- |
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