Pharmacovigilance Software

Signal Detection & Surveillance

Offering solutions that provide rapid, efficient access to evidence from multiple sources

UBC helps clients proactively manage risks with customized, comprehensive signal detection, strengthening, and refinement solutions.

UBC’s innovative software  – CLÆRITY® and SÆfetyworks® - are web-based, user-friendly analytical tools that enable our clients to better understand their products and minimize exposure to risk. Powered by industry-leading UBC data mining, epidemiology, and risk management experts, our technology-enabled solutions exploit large repositories of automated healthcare data, reducing the time, effort, and expense of examining drug safety issues.

UBC Knows

Now more than ever, manufacturers must be prepared to adapt to evolving regulatory guidelines and initiatives for drug safety.  That makes broad access to real world evidence vital, and tools that effectively identify and evaluate drug safety issues key to optimizing lifecycles.

Many current methods of signal validation and refinement require costly, labor intensive analyses, leaving manufacturers unprepared to rapidly respond to regulatory inquiries with real world evidence. 

UBC Understands

A knowledge gap between detection and adjudication exists.  Yet, manufacturers need informed, reliable results quickly.  CLÆRITY and SÆfetyworks are customized, comprehensive signal detection, strengthening, and refinement tools manufacturers trust to:

  • Reduce the time and resources needed to evaluate data
  • Prioritize signals more confidently in less time
  • Identify signals requiring further study and lessen the potential for exposure
  • Reduce channeling bias quickly
  • Apply insights from experts in pharmacovigilance and risk management
  • Respond rapidly to internal and external inquiries
  • Easily incorporate a variety of data sources and standardized approaches while creating reproducible results

CLÆRITY is web-based software and related services that provide our clients with data mining solutions tailored to meet their specific needs:

  • Signal detection utilizing disparate databases, including AERS, VAERS, Vigibase and client data. 
  • Software licensing, fully outsourced data mining services, or a combination of software and services
  • Unique CLÆRITY  software that:

    • Incorporates industry standard and state-of-the-art data mining algorithms for full coverage
    • Supports ongoing, collaborative workflow for managing and tracking signals
  • One-time analysis of specific issue or on-going surveillance for drug portfolio

SÆfetyworks is web-based software that rapidly analyzes large healthcare databases.  Drug safety scientists and epidemiologists rely on SÆfetyworks for:

  • Data queries invoked through point-and-click user interface

    • Descriptive, real-world patient characteristics including demographics, co-morbid conditions, concomitant medications
    • Frequency, incidence, and prevalence of drug or outcomes of interest
    • Product prescribing patterns and treatment patterns
    • Signal detection capabilities aligned with Observational Medical Outcomes Partnership (OMOP) methods research
    • Relative risk of outcome of interest controlling for confounding
  • Support for multiple, disparate administrative claims and electronic healthcare record databases
  • An Active Surveillance platform that:

    • Focuses signal detection using healthcare databases
    • Efficiently triages and prioritizes signal refinement
    • Rapidly responds to internal and external inquiries
  • Expert services for analysis, workflow, and process integration

Commitment to Success

SÆfetyworks received the 2009 BioIT Best Practices Award for Translational and Personalized medicine.

Contact Us

UBC can design a custom, global drug safety plan for your product. Contact us for more information.

 

Thought Leadership

Adverse Event Reporting - Are You Compliant?

Poster: A Signal Management Adaptive Model

Webinar: Specialty Pharmacy's Increasing Role in Pharmacovigilance

Article: Monitoring product safety in the postmarketing environment

Exploring the FDA’s Prospective Routine Observational Monitoring Program Tools (PROMPT) for Safety Surveillance

Brochures

Database Analytics Automation

Pharmacovigilance, Risk Management, Signal Detection and Management

UBC Solutions