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Establishing case quality metrics
Pharmaceutical Executive Magazine, 05/01/2012
Measurement of case quality in pharmacovigilance is a relatively new development. Until pharmaceutical companies began outsourcing their case processing operations, the only measure of effectiveness of their internal operations was compliance with regulatory reporting timelines. Now that these operations are performed by vendors, over the last two years vendor management organizations within pharmaceutical companies and Health Authorities have come up with a way to measure the quality of Adverse Event (AE) cases. This paper captures our experience and learning in defining and using case quality metrics while working with large and small pharmaceutical companies