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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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| About us |
| We are a quality-driven contract research organization (CRO) serving the pharmaceutical industry and specializing in Drug Safety services... |
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Medico-legal/Litigation reports |
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These are case reports originating from filed lawsuits, forwarded to QSI typically by the MAH’s legal department, and contain a list of damages (events that are the subject of the legal action). The source documents includes plaintiff facts sheets, medical records, e-mail communications, jury trial demand notifications, deficiency letters and summons etc. |
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Literature reports |
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These are case reports where an adverse event associated with a marketed or investigational product has been generated from a systematic search of commercial scientific databases of published peer-reviewed journal articles. In these, only a generic name of the marketed or investigational product may have been reported, and quite often the manufacturer cannot be determined. Translation of literature abstracts, articles and other safety data from various foreign languages to English is also offered . Literature search and review services are also offered.
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E2B reports |
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These are case reports from E2B gateway transmission between MAH and regulatory authorities/business partners. The processing of such individual reports includes identification and structuring of standard data elements which are missed during electronic transmission following ICH electronic standards for the Transfer of Regulatory Information (ESTRI). |
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