Outsourcing
Firms outsourcing clinical research for a number of different reasons. The theory of comparative advantage underlies CRO, as firms in other countries might be able to do the research more effectively, or more efficiently. Often, CRO done in order to save money, as is particularly the case with India. In other instances, the outsourcing is done to firms that have developed particular specialties in research (Piachaud, 2002).
In India, firms are competing for jobs doing clinical research, and that competition has driven down costs. This is important for the industry, because the cost of new drug approval has reached over $1 billion, in part because of the high costs associated with clinical research. So greater competition in research, and using lower-cost labor, has helped companies contain that cost (Jayaraman, 2004). Different payers also make it easier to recruit people for trials in some countries, thus lowering the time spent on the latter clinical trial phases. At that point, the patent will already be in place, so speeding up the trials process will allow us to get the drug to market faster.
Some tasks are easier to outsource than others, however. One task that is difficult to outsource is research...
outsourcing clinical trials that individuals and organizations looking to do so need to consider. Many of these different facets pertain to the contracts provided for this particular process. The principle services that one will need to procure, of course, are those of the research company that will be utilized to outsource the clinical trials. In the situation presented in this assignment, there are two individuals, one of which has
Clinical Trial Outsourcing Contract Issues in the Outsourcing of Clinical Trials The increasingly common practice of outsourcing clinical trials for pharmaceutical research and development is fraught with legal and ethical complications, especially as much of the outsourcing finds these clinical trials taking place in underdeveloped countries that lack infrastructure and appropriate civil and social oversight. In a scenario such as the one described, where an unequal partnership shares certain rights to the
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Contract Research Organizations Reality There are numerous reasons that can explicate the fact that contract research organizations or CROs have become so popular of late in the conduct of clinical trials. Some of these pertain to basic financial necessities. The prices of materials used in clinical trials and in the pharmaceutical business in general are increasing. According to Forbes (2011), "A survey by RW Baird analyst Eric Coldwell found 42% of
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