Synowledge assists companies in adopting a formal signaling methodology that incorporates all relevant data sources in order to better understand the risk-benefit ratio of a product, and discover product adverse event relationships. This is now required by law in Europe (Volume 9A) and by guidance in the US (FDA Good PV Practices and Pharmacoepidemiology guidance). Synowledge’s proactive signal detection services allow life sciences organizations to rapidly, and effectively identify potential risks and maintain compliance.
Visualization
The latest European guidance on signaling emphasizes the need to assess the medical significance of signals in order to refine the results of statistical measures of disproportionality. Our signaling services allow clinical experts to evaluate medical significance through the use of sophisticated visualization techniques that simplify the process of signal screening of aggregate data.
Data Sources
The use of external data sources allows for estimates of differences from known background rates. These data sources can be used for the review of data mining, as well as the statistical analysis of signal scores for client products as well as competitor products.
Our analyses merge data from the following sources; where available:
Company Data (Safety, Clinical, Registries, Sales)
External Data Sources (FDA AERS, WHO Vigibase)
Our analyses merge data from the following sources; where available:
