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 intellectual property and the physical substance that will be undergoing the clinical trial, new wrinkles in the responsibilities of parties and the necessities of established contracts arise. Looking to current research in the area can help determine the services and contract constraints that will be required to create an ethical and effective clinical trial that serves the immediate research and development needs of the pharmaceutical partnership hiring a central African...
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
Translating Biomedical Innovation / Mental Health and well being Managing Ideas: Commercialization Strategies for Biotechnology This article by Joshua and Scott Focuses on the commercialization aspect of biotechnology and stresses how important it is for innovators in the new and fast developing field of biotechnology to effectively forge collaboration with existing pharmaceutical market leaders in order to successfully create a new and strong value proposition for the healthcare sector. Biotech firms have
It so happened that Russian doctor Karlov was trying to find patients for another clinical trial for an experimental drug, and Ershov fit the requirements to enter the study. "They told me the treatment was safe," says Ershov. "I trust my doctor completely." Like 90% of Karlov's other clinical-trial patients, he immediately signed the consent form (Lustgarten, p. 1). Russia is one of those countries that suffers from high
To protect themselves, many Americans chose to avoid working with or becoming friends with those who immigrated. A lack of trust permeated everything that the Americans did in regards to the immigrants, at least with the men. This was not always true of the women, as they often got along together and shared the trials and difficulties of raising families. However, many men who owned shops and stores would not
cloud computing will be discussed to show that the good outweighs the bad. Furthermore, it will be further discussed that the government is looking into using cloud computing because it will cut IT cost down and increase capabilities despite the fact people are concerned with security issues that this may bring to the public. In completing a dissertation, it is very hard to go through the challenges that it requires.
PK = Deltagen Inc. PRXL = Parexel International Corp. Pvt1 = Quintiles Transnational Corp. (privately held) Industry = Biotechnology As of 2005 Source: Yahoo! Finance, April 29, 2007. Figure 1. Financial Performance: Charles River Laboratories vs. Deltagen Inc. And Parexel International Corp. - January 2002 to date. Source: Yahoo! Finance, April 29, 2007. Operating income for 2006 was reported by the company to be $188.2 million compared to $184.7 million for 2005 and its operating margin for 2006
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