Easily Uncover Safety Signals in Adverse Event Data with CLÆRITY®

Easily Uncover Safety Signals in Adverse Event Data with CLÆRITY

Easily Uncover Safety Signals in Adverse Event Data with CLÆRITY®

Disparate databases containing spontaneous safety reports vary in quality, quantity, and format, making it difficult to leverage these databases to identify and investigate safety signals.

UBC’s CLÆRITY software allows safety investigators to quickly uncover, manage, and investigate potential safety signals. Through an easy-to-use web-based interface, users can harness powerful algorithms to explore Adverse Events enclosed in AERS, Vigibase, and other data sources, including a manufacturer’s own database. These analyses are ready in seconds, not weeks.

Through CLÆRITY analysis tools, safety investigators are able to explore spontaneous reporting data, identify drug and event combinations that are reported in a higher-than-expected frequency, and track “signals of disproportionate reporting” over time. The analysis tools allow for:

  • Detection and investigation of potential safety signals using data mining algorithms
  • Management and monitoring of signals of interest over time
  • One-time baseline analysis
  • Periodic surveillance and signal tracking for baseline analysis across data updates
  • Planned, standardized quarterly reports as well as ad-hoc, customized queries
  • Customized reports that organize and summarize underlying spontaneous data

Real-time results are displayed in a compelling and easy-to-understand format. For example, the intuitive PVmap™ charts, like the one below, plot an event’s ‘certainty’ vs an event’s ‘disproportionality,’ allowing a user to quickly see strong disproportionate signals rise from the background noise. Charts can be filtered to pinpoint the event or set of events a user is looking for.

CLÆRITY can answer critical safety and epidemiological questions, such as:

  • What are the significant signals for a drug, class or group?
  • Is signal strength changing over time?
  • How do safety profiles of similar drugs compare?

Contact us to discuss your specific safety and epidemiological questions or to request a demonstration of CLÆRITY capabilities.