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A Biotech Manager's Handbook by M Hopkins, M O'Neill

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11

Clinical trials: design and practice

Russ Neal

Abstract.

Getting a product tested in the clinic is the goal of every therapeutics-focused biotech company. This involves an enormous amount of time, effort and money, so much so that many people in companies imagine that getting a compound into the clinic is the end of the process, but far from it. Testing a product in the clinic also involves an enormous amount of time, effort and money, and careful planning of a clinical programme is essential. The area of clinical research has been transforming over the last decade. Specialist clinical research organisations (CROs) are doing much of the work that once was the preserve of in-house specialists within pharma and biotech companies. Trial designs ...

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