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ticularly when taking products in development from the United States to Europe and other countries. |
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With the ever-increasing regulatory demand for the approval of medical devices, particularly in the United States, many medical device companies who had not built a substantial clinical research infrastructure are now also turning to CROs for study support. |
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E. Preferred Supplier Relationships |
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Another clear indicator of maturation in the CRO industry is the development of preferred supplier relationships or strategic alliances between pharmaceutical companies and one or a few CROs who have generally been selected on the basis of their specific expertise plus scope, capacity, and quality of service. Many companies who had adopted the use of CROs over the past 10 to 15 years suddenly have found themselves working with as many as 40 or 50 individual service providers often with no central or standardized mechanism for the selection, contracting, or management of the CROs, resulting in inefficiencies and lack of control. |
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Today, many major U.S.-based CROs have entered into preferred supplier agreements with one or more sponsors. The preferred supplier relationships have many specific advantages for the sponsor, such as |
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Increased efficiency of the initial proposal and bidding process as a result of a reduced number of bids to review and a clear understanding of the scope of work that can best be achieved through a close and long-term working relationship between the parties. |
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Elimination of study-specific contract negotiation as the long-term relationship is typically governed by a master agreement that spells out terms and conditions and simply requires the addition of a specific task order with an approved budget to initiate a new project or activity. |
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More rapid study start-up as a result of the advantages listed above plus reduction in the time required for identifying and training human resources, transferring standard operating procedures, technologies, and systems (e.g., in project management, communications, data transfer). |
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An established confidence in the operating philosophies, processes, and capabilities of the CRO and key staff members. |
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Benefits from advanced technologies, enhanced operating systems, and growing staff expertise while progressing from one project to another. |
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Cost savings as a result of the efficiencies noted above plus a clear understanding of service rates, the program budget, and a reduction in the risk of cost over run. |
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The CRO in such a relationship also accrues important benefits including |
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