ADRiumTM Signals

End to End Drug Safety PV Suite

About ADRiumTM Signals

ADRiumTM Signals is a web-based analysis solution for detecting, analyzing, and managing safety signals from clinical and post-market drugs, biologics, vaccines, devices, and combination of products. ADRiumTM signals generates statistical scores for combinations of drugs and events in a drug safety database for identifying signals. The source data can be an organization’s drug safety database or regulatory databases such as FDA Adverse Event Reporting System (FAERS), Vaccine Adverse Event Reporting System (VAERS) and WHO Vigibase.

ADRiumTM is a regulatory complaint, comprehensive signal detection system with advanced algorithms for generating signals of disproportionate reporting (SDR) for drug event combinations for identifying safety concerns based on observed/expected ratio within a drug safety database or from diverse datasets.

ADRium Signals capabilities

  • Data mining of drug-event combinations for signals using statistical signal detection methods.
  • SDRs for Subgroup analysis (Pediatric, Geriatrics, adults), drug interactions and overdose.
  • Provides SDRs for all statistical methods PRR, ROR, EBGM, CHISQ for better comparison.
  • In-depth analysis of case series for signals validation and evaluation.
  • Provides SDRs for drug event combinations from regulatory databases FAERS, VAERS and WHO Vigibase.
  • End to end signal management, such as validation, evaluation, and risk mitigation.
  • Signal management tracking and timelines.
  • Monitors watchlist and Important Medical Events (IME) events for proactive signal detection.
  • Build to reduce false positive and detect false negatives based on data sample size and stratification.
  • Routine (monthly, quarterly, bi-annual, annual) and ad-hoc signal detection activities.
  • SDRs review signoff, inclusion of review comments (free text and standard comments)
  • Identify labelled events, shows previously reviewed comments for given drug event combination for user friendly.

Our experienced team of drug safety physicians, safety scientists, SMEs, statistical and epidemiology experts work together with client safety teams to support signal detection and risk management activities for client products.

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