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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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| Our strengths |
| QSI is an organization specializing exclusively in Drug Safety. Our primary strength is Safety Operations... |
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| This service entails the analysis of grouped data and the subsequent incorporation of such data into prescribed reports on behalf of our clients. These reports include: |
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| a) |
| Periodic Safety Update Reports |
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| At QSI, PSURs are written by physicians in close liaison with the client for ensuring compliance with the applicable regulatory requirements. This work includes (one or more of) the following: |
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Assessing the adverse event reports included in the dataset of the PSUR review period |
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Deciding which events require to be discussed in the PSUR |
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Writing narratives, including a comment on the medical assessment of the selected case reports |
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Reviewing literature publications |
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Including information on the company's reference documents and updates |
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Including information on the overall safety evaluation of the drug, including drug interaction, overdose, lack of efficacy, pregnancy conditions, abuse, signal work-up data provided by the client |
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Adding Regulatory and Marketing data provided by the client |
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Compilation of appendices |
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| b) |
| Addendum PSURs |
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| For an addendum report, which is usually an interim report written for a shorter review period as compared to the usual periodicity of the PSUR, a process similar to that for a standard PSUR is followed. Individual case narratives for cases of interest are normally not included in the addendum report. |
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| c) |
| Summary Bridging Reports |
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| This report is an overview of two or more (generally 4-5) PSURs. The report follows the pattern of the sections included in a PSUR. |
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| d) |
| Six-monthly SUSAR Reports |
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| An SSR includes a brief report of individual SUSARs (Suspected Unexpected Serious Adverse Reaction) reported during the six-month reporting period either for the drug and/or an associated comparator, along with associated line-listings. The purpose of an SSR is to inform Ethics Committees and competent authorities of any events that could adversely affect the safety of trial subjects. |
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| e) |
| Related services |
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Signal detection |
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As part of the signal detection process, QSI performs several services for its clients: |
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Literature reviews |
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This involves reviewing literature abstracts and complete articles, retrieved in a commercial keyword-based search from established databases. Single case safety data is not considered in this service. |
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Event analyses and Issue work-ups |
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QSI performs EFI (Events for Further Investigation) analyses and report writing services, as well as the medical analyses of case reports included in signal work-ups |
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Proportional Reporting Ratio analyses |
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PRR analyses may be undertaken for clients, if required. |
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