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the outset to support the full clinical development process encompassing regulatory, medical, project management, clinical monitoring, data management, biostatistics, and report preparation functions. |
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C. Multinational Expansion |
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In response to the global demands for clinical research services from the established multinational pharmaceutical industry and the rapidly evolving international orientation of biotechnology companies, the major U.S.-based CROs began offering international services in the mid-to-late 80s, some based on internal growth and the establishment of European offices such as Besselaar, Quintiles, and ClinTrials Research. Others, such as Parexel and Pharmaco entered Europe through acquisition or joint venture. The strategy of mergers and acquisitions, though uniquely challenging to manage, has become the most common approach to expansion in the 90s as it provides rapid access to additional expert resources in new markets and facilitates the integration of new services such as preclinical and clinical laboratories as well as drug packaging and supply. The acquisition route is not limited to U.S.-based CROs as European companies such as Biodesign Institute for Clinical Research and Innovex have made acquisitions in the United States in recent years. |
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Although the early focus of CROs was on the U.S. and European markets, recent years have seen expansion into Australia, South East Asia, Japan, South Africa, Israel, Eastern Europe, Russia, and Latin America, in concert with client demands. Japan represents a potentially major growth market for CROs, not only because of the increasing demands of Japanese pharmaceutical companies to develop products in the United States and Europe, but also as a result of increasing medical, business, and an expected regulatory acceptance of CRO participation within the country. |
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Great strides have already been taken in Japan including, among others, the acquisition of U.S.-based Institute for Biological Research and Development (IBRD) by Koraya, a Japanese pharmaceutical distributor; the announced initiation of activities by other leading U.S. and European CROs; the establishment of CMIC Co., Ltd. and MediScience Planning, K.K. as two leading Japanese CROs; and a long history of Japanese Phase I units such as Sekino Research Institute and Osaka Pharmacology Research Clinic (OPHAC). However, major challenges still exist in Japan. For example, two CRO associations have been established, one that represents Phase I companies and another, the Japanese CRO Association, that is limited to organizations providing clinical research services from Phase IIIV. Moreover, Koseisho, the Japanese drug regulatory agency, has not formally endorsed the use of CROs. Nonetheless, the third international conference on harmonization (ICH-3) in Yokohama in late 95 is expected to facilitate a greater harmony in how pharmaceutical |
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