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Central and Core Laboratories: The Definitive Guide to the Current Status and Future Prospects of Central Clinical Pathology, ECG and Imaging LaboratoriesPublished by: Biopharm Knowledge Publishing Published: Oct. 1, 2007 - 250 Pages Table of Contents
AbstractThis report will show that the central laboratory business is today a global business worth over $1.5 billion. It is a business that is indispensable to the research based pharmaceutical industry. The report traces the fascinating history of clinical pathology and shows how this medical analysis "lab tests", has come to form the basis of the global central laboratory business.Today much of the clinical development of new drugs is outsourced by the pharmaceutical industry. This outsourcing is managed by hundreds of contract research organisations world-wide ranging from global industry leaders such as Covance to small two person niche companies. The proportion of the work outsourced continues to grow at a healthy double digit rate and today approaches 30% on average. Laboratory pathology analysis of blood, urine and other patient specimens is on the other hand, outsourced at a virtually 100% level with few parameters, usually biomarkers, being analysed in the pharmaceutical companies’ laboratories. The central laboratory business is by its very nature a global business now that the pharmaceutical industry has moved to global drug development. Unlike contract research organisations a small pathology laboratory cannot compete and the vast majority of the business is concentrated in the hands of relatively few, perhaps 20, large players. The report provides a detailed review of these companies. For those whose daily work does not bring them into close proximity with central laboratories this report is a useful primer on what the laboratories do, how they are equipped and how they fit into clinical drug development programmes. Choosing a central laboratory and then contracting with it are vital to the successful outcome of a clinical trial. How these are best accomplished is addressed in the report. It is not often appreciated how important logistics are to the success of a clinical trial and to the role of the central laboratory in it. Up to 40% of the cost and, some would say 100% of the difficulties of safety analysis lie in the transportation of specimens from the patient to the central laboratory. The authoritative chapter on logistics addresses this issue in some detail and provides invaluable help in traversing this particular minefield. Pathology was the first analytical discipline to be centralised and this report concentrates on the central laboratory. However imaging and electrocardiology measurement have both in recent years been centralised and this report has not neglected these topics. Get Full Details About This Report >> |
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