To present it in a more simplified way, Signal Detection or Signaling represents the detection of early warning signs throughout the lifecycle of medicinal products. The association between certain drug and ADR is identified by certain statistical tools. This identification for certain drug-ADR pair is known as Quantitative Signal detection.
It refers to computational or statistical methods used to identify drug event pairs (higher-order combinations of drugs and events) that occur with disproportionately high frequency in large safety databases.
ARS PV offers inbuilt high-end Signal Detection tool for Pharmacovigilance datasets, combining advanced data mining algorithms with qualitative review of each identified ICSR of interest, which is a scalable and advanced solution. ARS PV helps clients proactively manage risks with customized, comprehensive signal detection, strengthening, and refinement solutions.
How ARS PV Signal Detection tool facilitates & It’s calculations
- Screening, data mining and frequency tabulation for potential signals, including signal estimation using established statistical signal detection methods.
- Our expertized team of safety SMEs, statistical and epidemiology experts work together with technical teams to deliver you accurate signal of your product using ARS PV.
- Signals in ARS PV is calculated on PRR, upper bound – lower bound CI’s and also corresponding Chi square values, for identifying statistical signals.
- User friendly access for the ARS PV users.