Today''s heightened focus on drug safety requires new tools for you to effectively argue your case. Primus Analytics is pleased
to be the first firm to offer syndicated reports providing a detailed review of the FDA''s Adverse Event Reporting System. This data has to date, never been available in a fashion that would allow you to make effective arguments. Our proprietary analytical model transforms hundreds of thousands of
observations of raw data into coherent and tangible information by product that will no doubt augment and strengthen your case. Heretofore, much of the
clinical focus on safety has been limited to published clinical trial data which has obvious limitations, most notably: a.. Clinical trial participants are typically not representative of the general population due to rigorous exclusion and inclusion criteria b.. Co-morbidities and concomitant medications, while a reality in the real world, are rarely studied in a clinical trial c.. Expertise, monitoring, and follow-up in a clinical trial setting is vastly different than that of the real world As a result safety signals that should have been identified in the drug approval process are systematically eliminated. The FDA''s Adverse Event Reporting System in almost every case will provide you with data confirming the safety signal of interest. For example, the AERs database included over 90,000 observations of cardiovascular problems with Vioxx and over l7, 000 cases of myocardial infarction offering quantitative validation of the case against it that no other source has yet provided. Further, the AERs database also includes over 20,000 cases of hospitalization, almost 6,000 reported deaths, and 9,000 observations of disability. Each case report offers further detail from each individual case observation to the entire category.Visit the source website, www.primusanalytics.com, today to purchase one of our syndicated reports or request a custom analysis of any product.