Signaling
In adverse event management, every case matters. That’s why Sentrx has developed a variety of strategies, tactics, tools, and technologies to ensure that every ICRS we manage enables meaningful assessment. Signal detection is one of the most vital aspects of a pharmacovigilance, and we can work with you to design signal detection services in many different ways.
At the individual case level, our goal is to gain insight through our core adverse event management processes. By establishing regular communications between our PV team and your leadership, we create another layer of detection, allowing you to tap our PV specialists’ observations. We also regularly communicate with global safety teams and clinical investigators directly or through advanced, Internet-based collaboration tools to develop a deeper understanding of the forces at work. Sentrx’s careful crafting of global safety feedback systems enhances the awareness, knowledge, and information of all stakeholders.
At an aggregate level, our methods bring together observations by clinicians and patients, assessments of individual case histories or clusters of reports, and anomalies detected in observational databases and clinical trials. We use digital monitoring and computerized epidemiological and statistical analytics along with advanced data visualization techniques to aid the process of examining tens, hundreds, or even thousands of reports. We’ve established a platform leveraging our expert clinical case assessment abilities with the processes and technologies necessary to ensure your needs for quarterly report generation, signal prioritization, and aggregate data signaling are always met efficiently and effectively.
At Sentrx, our approach takes the best of automated signal generation, statistical methods, and third-party data sources and synthesizes it with the kind of human knowledge, experience, and expertise only professionals with years in pharmacovigilance can give.
If insight is your goal, talk to Sentrx.
About Signals
The whole process of risk/benefit evaluation depends on effective detection of signals, which the World Heath Organization defines as “reported information on a possible causal association between an adverse event and a drug, the relationship being unclear or incompletely documented.”
Talk to Sentrx about our unique syndicated signal platform.
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Kim DeFronzo, RPh VP Medical Affairs |
