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As per GVP module guidelines, we provide summary tabulation reports of AEs, which can be filtered by serious and non-serious events, which are vital to risk management.
Event-based tabulation report with bifurcation of listed and unlisted event counts with period of submission and today’s date from MA date
A data mining algorithm with a qualitative analysis of each ICSR of interest, the current standard in Pharmacovigilance.
Globvigilance performs ongoing signal evaluation and management for clinical and marketed products, including label update analysis and physician review for any identified and potential signals
QUANTITATIVE
• Helps in identifying statistical signals of disproportionate reporting.
• Once statistical signals are identified, the database allows clinical evaluation of each ICSR for the identified SDR (Signal of Disproportionate Reporting),
thus differentiating true clinical signals from statistical noise or reporting artifacts.
QUALITATIVE
During the initial assessment of ICSRs, it routinely flashes Targeted Medical Events and Adverse Events of Special Interest as ‘to be monitored’ Drug –
Event combinations, thus facilitating Index or Striking case method of Traditional Signal detection.
