Safety and Risk Management

Signal Detection and Risk Management

Advanced tools and knowledge take the noise out of early detection

4Identifying 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. Sciformix has 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.

Resources

SRM-brochure-thumbSafety and Risk Management capabilities brochure

Sciformix’s Integrated Drug Safety solution seamlessly interweaves and synchronizes case processing (ICSR), aggregate reporting (PSUR, PADER, PBRER, ASR) and risk management across all phases of the product lifecycle. Our scientific experts aggregate and evaluate safety information from all sources, including individual cases, published safety data and competitive products to facilitate evidence-based proactive drug safety decisions.

Download information on our Safety and Risk Management services. (PDF)

SmartSourcing-thumbSmart sourcing strategy for pharmacovigilance vendor selection

Strategic planning, sourcing and implementation of pharmacovigilance operations are multi-dimensional activities that require consideration of factors across the spectrum. Over the past few years there has been a positive increase in the quality and quantity of safety processes being outsourced. The trend is largely due to evolution of mature processes; risk mitigation strategies and increase in vendor experiences that has helped the sponsor balance core in house strength and leverage the service provider’s capabilities. Though approach towards outsourcing pharmacovigilance is largely tactical, strategic partnership with a vendor is not uncommon.

Download information on our Smart sourcing strategy. (PDF)

ScignalPlus-thumbScignal Plus

Scignal Plus provides superior, efficient signal detection by incorporating computational algorithms for a new method and previously known methods of signal detection. It has several distinct and important advantages over other products that are available in the market.

Learn more about Scignal Plus. (PDF)