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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 processing of individual adverse event reports (ICSRs) originating from various sources: |
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| Following
established guidelines, source documents sent
to QSI by its clients are entered (MedDRA
coding) on to a Drug Safety/Pharmacovigilance
database, after a duplicate search, on behalf
of those clients. This may involve an initial
triage and a subsequent medical review/assessment
of the report by physicians. |
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| a) |
| Spontaneous reports |
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| These can be serious or non-serious event reports from the following sources, originating after a product has been marketed by the Marketing Authorization Holder (MAH): |
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Government agencies |
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Industry |
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Hospitals |
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Academia |
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Medical and Pharmaceutical Associations |
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Poisons and Medicines Information Centers |
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Health Professionals |
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Patients |
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Consumers |
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Media |
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| Both serious and non-serious event reports are processed by QSI. |
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| b) |
| Clinical trial reports |
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| These are adverse event reports originating from clinical trials involving investigational products. Only serious events and non-serious events of special interest are reportable to the health authorities. Such events may be considered related or unrelated to the investigational product by the investigator/client. |
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| Both related and unrelated event reports are processed by QSI. |
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| Serious Adverse Event (SAE) Case Narrative Writing services are also provided by QSI for reports from clinical trials. These are written typically after the database lock point and submission of the ICSRs to the health authority. |
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| c) |
| Special reports |
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Legal reports |
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These are case reports originating from filed lawsuits. These cases are 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 fact 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 all 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. |
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| d) |
| Related services |
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| Briefly referred to earlier, QSI offers, in addition, the following 'stand-alone' services to its clients. |
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Medical review |
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After case processing is complete and before submissions to the health authority, the case is reviewed by a physician or a healthcare professional to confirm the medical cohesiveness of the data that is going to be submitted. The medical reviewer or assessor checks the labeling that has been added by the case processor, and checks the narrative and the CIOMS comment to ensure that it makes medical sense. Any missing medical information is requested at this stage. |
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Medical triage |
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Individual case reports received from clients are reviewed by the healthcare professionals and physicians to check for proper classification, and assessment of their priority and compliance timelines that need to be followed. The priorities depend on the seriousness of the event, the causal relationship, and the product involved. |
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Serious Adverse Event (SAE) reconciliation projects |
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QSI frequently carries out reconciliation work on behalf of its clients. Such projects can be diverse in nature and thereby hard to categorize. However, one particular type of project work is relatively common and pertains to the reconciliation of SAE data between the clients' Drug Safety (or Pharmacovigilance) database and their relevant clinical databases. This comparison may be facilitated by the use of automated comparison tools. The discrepancies noted between the two databases are determined and documented, since these may ultimately require correction. |
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