Trend Analysis &
Benchmarking Review
Aggregate Data Interpretation and Trend Analysis
SafetyCall clinicians routinely help clients understand their ongoing safety surveillance experience by analyzing the aggregate AE data. Coupled with individual case assessments and applying best practice trending approaches, SafetyCall data analysis allows:
- Review of normalized to sales incidence rates for all AE allegations of injury broken down by age and outcome
- Tracking of expected incidence rates to determine an acceptable range for likely events and identify unexplained variations to that range in any given time period
- Identifying incidents that may signal a safety issue as well as those reported events that are more likely to be representative of background noise
- Identifying likely causes or contributing factors for suspected sentinel events or deviations from expected incidence rates
- Assessment of the level of concern for any identified adverse effects and an evaluation of the likely adverse health impact to consumers using the product
Benchmarking within and across product lines and categories
Every product has its own safety profile, and SafetyCall helps its clients establish and understand the profiles of their own products. Assessing and benchmarking these safety profiles usually requires examining them against others in their market and determining how their product compares to the competition, or even against other products within the company’s existing line. SafetyCall experts have more than 30 years’ experience in this with every consumer product category, and can determine how the product risk/benefit equation can be accurately presented to manage or mitigate risk, maximize benefit and enhance the product life cycle.
Case Consistency Assessments and Scoring
Most companies that document their adverse event experience have systems in place to collect and tabulate information provided by consumers and others regarding adverse events potentially involving the use of a company’s product. Although putting in place a basic documentation system may help companies meet the letter of the law, best practice companies understand the need to fully understand their adverse event experience so they can confirm that their products are meeting their intended purpose without unintended consequences. This requires a stepwise process of documenting, tabulating, analyzing and, when required, reporting of adverse events to regulators or even insurers. There are a number of things that distinguish the post-market surveillance services of SafetyCall from the basic call intake and documentation procedures that are typical of most customer service complaint handling services. SafetyCall service offerings in this area are designed to help companies meet each step of a total solution best practice surveillance system including:
- Individual Case Assessments
- Aggregate Data Interpretation and Trend Analysis
- Benchmarking within and across product lines and categories