2 Pharmacovigilance Solutions for Clinical Trial Safety Reporting

ipad dataIn order to ensure safety and comply with pharmacovigilance regulations, massive amounts of safety data must be analyzed. Arithmos explains how automating pharmacovigilance systems can improve the identification of adverse events through real time data results. Arithmos summarizes two safety reporting solutions for clinical trial safety reporting.

 

clinical1. Automating Signal Detection 

Combining statistical analysis, statistical programming and IT support under a commonly used platform like SAS is an ideal solution for automating data collection and analysis from multiple sources to implement an efficient signal detection process. In order to automate the process, a system needs to be in place to pull and analyze data from the safety database. The key aspect is the data integration between safety databases, regulatory databases, and patient data from external database sources.

The identification of signal criteria and the implementation of standardized programs automates the signal detection process. It also produces structured data which speeds up the task of finalizing Eudravigilance submissions.

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2. Integrating Oracle AERS with Oracle Business Intelligence

The Oracle AERS and Business Intelligence integration is an investment in outsourced pharmacovigilance work which requires the need to access real time data and results. Arithmos integrates Oracle 9i database with Oracle Business Intelligence Standard One edition which creates an Oracle interactive dashboard that allows companies to constantly access data and results.

The Logical Business Model has automatic creations such as tables, but manual creation is also possible. The Oracle BI dashboard allows customization of page layout according to user requirements. The dashboard is interactive, which allows companies to access live data corresponding to user requirements.

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Arithmos will be a first time exhibitor at the DIA Annual Meeting in Boston next week. Stop by Booth 607 to discuss our pharmacovigilance solutions with us! 

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