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The need for clinical research is less for generic drugs but nevertheless may be needed for improvements.
2) Explain why the process or procedure produces a competitive product or service in the domestic and global markets
Other than the mandatory requirements the clinical trials are part of the quality management system. The credibility of the company depends on the effectiveness of the medicine it sells. So for both the companies the results of clinical trials and the opinions from the market and the medical fraternity is very important in improving the quality of the medicine and also bring about a better product to gain a better market share. The clinical trials thus help bring high-quality products to market not only in the therapeutic side of pharmaceuticals. For the generic drug segments that are a niche, high-barrier-to-entry products like the ones dealt with by Par Pharmaceutical the clinical trials are also important to establish the niche in the first place.
3) Explain how quality management affects the position of the companies in the domestic and global market
The competition between all companies is intensified within the domestic and global market. Medicines are being manufactured, tested and marketed on a global scale. (Sourcepoint, 2011) For example Par Pharmaceutical specializes in the generic versions of medicines like Accupril, Dostinex, Flonase, etc. mostly have manufacturing in the United States. But the product is marketed globally and the company also licenses many prescription drug products and its niche is the U.S. retail chains, to managed care organizations and even mail order pharmacies....
(Par Pharmaceuticals, 2011)
This market thus has thrown open the possibility of the company expanding its market and also entering global markets in future. This is possible only on the basis of the process of evaluation of clinical trial information. On the other hand Pfizer is a multinational that has many overseas commitments and have to be careful about the branded drugs it sells as it can become open to litigation, and also lose shares of the market if the drugs fail. Thus both have a stake in the clinical trial process.
References
Clinical Trials. Gov. (2007) "Understanding Clinical Trials" Retrieved 17 June, 2011 from http://clinicaltrials.gov/ct2/info/understand
MedReps Career. (2011) "Pfizer going for the e for world's first virtual clinical study"
Retrieved 17 June, 2011 from http://www.medreps.com/pharmaceutical-company-news/pfizer-goes-online-for-world~s-first-virtual-clinical-study/
Par Pharmaceuticals. (2011) "About Us" Retrieved 17 June, 2011 from http://www.parpharm.com/generics/index.php?option=com_content&view=article&id=49&Itemid=71
Pfizer. (2011) "Conducting Research & Clinical Trials" Retrieved 17 June, 2011 from http://www.pfizer.com/research/research_clinical_trials/conducting_research_clinical_trials.jsp
Sourcepoint. (2011) "Par Pharmaceutical Companies" Retrieved 17 June, 2011 from http://www.sourcepoint.com/profile/par-pharmaceutical.html
Time Inc. (n. d.) "Drivers of the Economy" Retrieved 17 June, 2011 from http://www.timeinc.net/fortune/services/sections/fortune/pdf/MinorityBusiness_wAds.pdf
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