Epidemiology Capabilities & Services
Our epidemiologic investigations are critical components of how we support pharmaceutical companies in their management of and response to risks.
We are routinely called on to perform the following types of investigations:
- FDA post-marketing safety studies. We have prepared briefing materials and presentations on study protocols and study reports for FDA advisory committee meetings. We have also conducted post-marketing requirement and post-marketing commitment studies based on data analyses. We use a variety of data sources, including claims data, electronic medical records data, medical record transcription data, hospital data, survey data, and registries.
- EMA post-authorization safety studies. We have conducted PASS studies mandated by the European Medicines Agency (EMA) based on information on a drug’s safety after it has been marketed, including a number of safety studies submitted to both the FDA and EMA.
- Pharmacovigilance studies. Our teams have analyzed the risks associated with drugs using FDA MedWatch data and internal company post-marketing drug safety data. Our assignments have involved spontaneous reports analysis and the development and application of safety signal detection methodology with spontaneous reports data from pharmaceutical companies, the FDA, and the World Health Organization (WHO). We have also assessed drug safety signal detection using social media data.
- Quantitative methods in observational studies. We have applied innovative methodologies to epidemiologic analyses and counterfactual modeling, such as marginal structural models, where challenges exist in estimating the causal effect using these observational data (e.g., time-dependent confounding and informative censoring).
- Patient and disease registries analysis. We have conducted numerous clinical and economic analyses involving patient and disease registries (e.g., SEER cancer registries, the US and European Bone Marrow Transplant registries, and the Johns Hopkins Lupus registry), disease-specific registries, and pregnancy registries.
- Forum Can Epidemiology Be Applied to Auto Safety Analysis?
- Related Focus Area Drug Safety Litigation
Studies of Adverse Events
Study of Safety and Efficacy of VEGF Inhibitors in Actual Use
- Health Care Bulletin Monitoring Online Signals: Implications of Internet Data in Pharmacovigilance
- AG Feature Using Epidemiology to Identify Unmet Need