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contract research organizations (CROs) on a worldwide basis. It has been estimated [12] that CROs have captured up to a third of the available clinical research market. |
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In the broadest sense, a CRO is any organization that provides a service for pharmaceutical, biotechnology, or medical device sponsors in support of a clinical research project or program. The CROs range from a single self-employed consultant through companies of over 1,000 staff members. Not surprisingly, the services provided by an individual will generally be highly focused, such as statistical analysis, protocol, and report preparation, or medical, scientific, or regulatory consultation. In contrast, the larger companies are likely to provide comprehensive product development services ranging from R & D planning and design through complete clinical program implementation, analysis, report preparation, and, ultimately, regulatory submission. Depending upon a client's need, all components of these services or a select subset may be provided. As the barriers for entry into the CRO business were originally not substantial, the majority of companies, both large and small, were initiated by medical, scientific, or business professionals with prior experience as employees of the major pharmaceutical, biotechnology, or medical device companies. |
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The concept of retaining expert consultation at various stages in the development of a pharmaceutical product is not novel; it was already common in the 1960s. Substantial organizations that were dedicated to Phase I studies began appearing in the 70s, including Quincy Research Center, Harris Labs, and Medical and Technical Research Associates in the United States, and Guy's Drug Research Unit and LAB in the UK and Germany, respectively. Pharmaco LSR, although being a relative latecomer to provide Phase I services, with operations beginning in the mid 80s, rapidly incorporated Phase IIIV services into its portfolio. Other Phase I units have gradually developed services in Phase IIIV as well, whereas other organizations such as Besselaar, Quintiles, and ClinTrials Research were initially formed to focus on Phase IIIV programs. |
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Based on the specialties of company founders and their early associates, many companies initially developed specific niche services, such as data management and biostatistics at Quintiles, a central nervous system emphasis at Cato Research and International Clinical Research Corp., and oncology at Theradex. In contrast, ClinTrials Research and Besselaar were formed from |
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