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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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| QSI also offers ‘stand-alone’ services to clients, as required. |
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Medical Review/Assessment |
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Review of a processed case by a physician or a healthcare professional to confirm the medical cohesiveness of data that is to be submitted to health authorities. Also includes the assessment of labeling that has been added by the case processor, and the checking of the narrative and CIOMS comment to ensure that it makes medical sense. All missing medical information is requested at this stage. |
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Medical Triage |
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Review of individual case reports received from clients by healthcare professionals and physicians to check for proper classification, assessment of their priority and compliance timelines. Priorities depend on the seriousness of the event, causal relationship and the product involved. |
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Serious Adverse Event (SAE) Reconciliation Projects |
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Reconciliation of SAE data between the clients’ Drug Safety (or Pharmacovigilance) database and their relevant clinical databases.Reconciliation is performed to assure that serious events are accurately captured, interpreted, and consistently reported to regulatory authorities. 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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Veterinary Adverse Events Reports |
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Processing of adverse reactions reports (animal AEs, human AEs, environmental AEs and residue AEs) associated with veterinary medicinal products that occur in animals across different therapeutic areas. |
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Ad-hoc Projects At a Glance |
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- Back-log clearing
- Correction of historical/legacy cases
- Data entry of legacy cases
- Data entry of line listing reports
- Data migration
- Data correction and clean-up projects
- End-of-study blind break (EOSBB) projects
- Inactivation/deletion projects
- New pilot projects
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