Signal Detection and Risk Management
Advanced tools and knowledge take the noise out of early detection,
Advanced tools and knowledge take the noise out of early detection
Identifying new potential risks and developing risk minimization action plans to prevent or mitigate these risks is at the heart of all pharmacovigilance activities throughout the product lifecycle. We have the knowledge, technology and expertise to qualitatively and quantitatively assess safety data, identify new safety signals and develop risk management plans (RMPs) for healthcare products.
Our capabilities include:
- Screening, data mining and frequency tabulation for potential signals, including signal estimation using established statistical signal detection methods
- Routine (monthly, quarterly, bi-annual, annual) and ‘ad hoc’ signal detection activities, generate signal reports and track signals for client products
- In-depth evaluation of potential signals by further medical analysis of case series, targeted literature search and review of data from external databases
- Developing and monitoring risk management plans and risk evaluation and mitigation strategies, and performing benefit-risk analysis
By actively engaging with our clients we develop and update RMPs for their investigational and marketed products. We have standard processes and proprietary implementation of algorithms and follow current regulatory requirements for signal detection and risk management activities. Our experienced team of drug safety physicians, safety SMEs, statistical and epidemiology experts work together with client safety teams to support risk management activities for client products.