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| What we do |
| QSI is specializing in providing two main types of services to global pharmaceutical companies... |
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| Our strengths |
| QSI is an organization specializing exclusively in Drug Safety. Our primary strength is Safety Operations... |
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QSI is very professionally managed. At the head of it is a Chief Executive, who has
14 years of international Research and Drug Safety experience, besides nine years of international Quality Management experience at the top level. |
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| The large scientific team specializes in Drug Safety/Pharmacovigilance operations. It consists of highly qualified physicians, healthcare professionals and scientific personnel, their numbers having grown more than 20 times in the last five years. |
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The scientific and quality staff is perfectly familiar with:
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General PV principles |
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ICH guidelines |
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Volume 9A requirements |
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FDA rules and regulations |
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| Further, QSI staff is well-versed in regulatory timeline requirements, submission criteria, MedDRA, CIOMS, and the use of company comments. |
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| QSI has been working in the Drug Safety area for the last five years; the average experience of the staff at QSI is about two years. The senior-most batch of scientists has been with the organization since inception for this entire five-year duration. The average age of the QSI scientist is just over 27 years. |
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| All PV scientists, other than the physicians, have a life sciences background and about 40% of them are healthcare professionals (pharmacists, dentists etc.). |
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| QSI has a clear and rational internal governance structure that has come about because of its organic growth. This governance structure has enabled QSI to deliver single case processing and PSUR services for the past five years to major global pharmaceutical clients, while maintaining an impeccable track record. |
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| Under this governance structure, the key functions at QSI extend to: Operations, Quality, Business Planning and Training. Each key area reports directly and independently to the CEO, and all functions are supported by the common IT, HR, Administrative and Finance functions. |
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