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Quintiles

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by

Dilip Rajan

on 28 July 2011

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Transcript of Quintiles

Pharmaceuticals a HIGH COST industry $$$$$$$$$$$$$$ Increasing regulations Tough economic times Looming Patent Cliff Lipitor Plavix Zyprexa Lexapro Levaquin Seroquil Actos Singulair Nov 2011 May 2012 Aug 2012 Mar 2012 Mar 2012 Oct 2011 Aug 2011 Jan 2012 Pharma Companies need to CUT COSTS Quintiles handles your CLINICAL TRIALS Phase 1 Phase 2 Phase 3 Market Phase 4 The drug is tested for effective dosage on a medium sample size of sick patients The drug is tested for side-effects on a relatively large number of sick patients Data Management eliminates redundant data organizes information These clinical trials collect a LOT of information about a LOT of people Such a large amount of information is often redundant difficult to organize & reduced efficiency To combat this problem, Quintiles has teams that deal solely with The refined data is sent to the Biostatistics team Biostatistics analyzes trial data constructs more effcient trials speeds up clinical trial process Trials are perfomed on a small sample of healthy patients to test for toxicity Trials are performed on a medium sample of sick patients to test for effective dosage Trials are performed on a large sample of sick patients *most expensive and crucial stage (NDA) After completing Phases 1, 2, and 3 of clinical trials Quintiles files a New Drug Application (NDA) to the regulatory agency for approval After the drug is in the market, it is exposed to a much greater # of patients New side-effects of the drug begin to appear Regulatory agencies require these to be tested and reported on drug labels Quintiles collects reports
on new effects of the drug Patients Personal physicians Regulatory agencies Media Independent groups ] Quintiles - organizes the claims - tests the claims for validity through further clinical testing New and verified
side-effects
are reported This process continues for the lifespan of the drug Pharmacovigilance Data Managment Biostatistics Pharmacovigilance provides your clinical trial needs cheaper & more effective
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