Signal Intelligence Services - PVTM
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Signal Intelligence Services-PV™ is Patni's outsourced drug safety analysis solution for post-marketing, clinical and pre-clinical safety data. This service is:
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Based on Patni's Signal Intelligence-PV™, a proprietary software
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Executed by healthcare professionals, and |
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Performed using internal company data, or external data from FDA AERS and WHO. |
The analyses are performed in accordance with the FDA’s March 2005 guidelines on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Results are presented in a comprehensive report that includes many visualizations from which conclusions are drawn by our medical experts.
Visual and Intuitive Graphical Output
Data Analysis and Interpretation
Signal Intelligence Services-PV provides standardized analysis of drug safety data without the need to implement a software product solution. The analysis can be based on a company’s internal and/or external data. The use of external data provides a comparison to other products in the same therapeutic area, as recommended by “Good Pharmacovigilance Practices.” Typical sources of external data are FDA AERS and WHO. Among the analysis incorporated into this service are:
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Clinical and laboratory manifestations and course of the event |
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Demographic characteristics of patients (e.g., age, gender, race) |
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Exposure duration |
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Time from initiation of product exposure to the adverse event |
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Doses, including labeled doses, greater than labeled doses, and overdoses |
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Use of concomitant medications |
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Presence of co-morbid conditions, particularly those known to cause the adverse event, such as underlying hepatic or renal impairment |
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Changes in event reporting rate over calendar time or product life cycle |
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