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to direct the fixed costs elsewhere, such as to discovery, manufacture, or marketing. |
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The CRO industry has responded to the changing environment with enormous appetite and with a great deal of success. Individual companies have experienced and continue to experience rapid growth. The industry is currently growing in turnover at a rate of 2025 percent per annum, and some of the more successful companies are enjoying growth of 40 percent. This growth rate has not been even across all sectors. Those experiencing the highest rate are in clinical monitoring, data management, regulatory affairs, and postmarketing surveillance, whereas Phase I activities have seen only a 5 percent growth [2]. Sponsors are now demanding more comprehensive cover for clinical monitoring, across Europe and particularly in the countries of the former eastern block, and great interest is being expressed about conducting more trials in South America and Australasia. It is now essential that a CRO provides data management and statistical and regulatory services, particularly if they wish to be selected for the potentially lucrative full service contracts. The appearance of drug packaging and labeling facilities within CROs is now also being seen by some clients as a major requirement. |
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As CROs have become more sophisticated and pharmaceutical companies have undergone major restructuring, the major CROs are increasingly being expected to take key roles in the design, conduct, and full reporting of entire development programs. This applies particularly to Japanese pharmaceutical companies and to the biotechnology industry. The American and European subsidiaries of Japanese companies depend heavily on CROs because they have only recently started to run large scale projects in the West and have not had time to build up the infrastructure required. Most biotechnology companies have a small number of compounds under development and cannot afford to build and maintain the clinical and regulatory departments needed to develop their drugs successfully. However, the requests for involvement at the design stages and full management of programs is not restricted to these two sets of clients. Some major American and European sponsors are also making such requests, often via strategic alliances or preferred supplier agreements [1]. |
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The challenge to the CRO industry through the remainder of the 90s and into the next century is to manage growth without becoming uncompetitive and to continue demonstrating that it can deliver a first-class quality product at a cost to its clients which they cannot match themselves. The challenge is to build and maintain a competitive infrastructure while main- |
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