Pharmacoepidemiology

Our epidemiology team investigates indicators of disease and drug usage and effects under real-life conditions, so you can make more informed decisions throughout the development and post-approval lifecycle of your drug. The results of these studies can provide scientific evidence that aids in the understanding and interpretation of data from clinical trials, post-approval studies and spontaneous reports. As recognized leaders in risk management, we collaborate with drug sponsors on their epidemiologic studies and routinely help them protect patient safety by designing, implementing and evaluating risk management programs. The types of studies we conduct include:

• Disease burden and prevalence
• Post-approval safety and surveillance
• Treatment patterns and impact
• Comorbidities
• Risk-factor assessments

Methodologies
We evaluate your research needs and utilize the most appropriate prospective or retrospective method(s) to study your drug epidemiology questions. Our experience is diverse and includes:

• Patient registries (cohort studies) of disease, product, pregnancy and safety
• Case-control studies
• Database studies (prospective, retrospective, longitudinal and cross-sectional)
• Patient and physician surveys
• Chart abstraction studies
• Naturalistic trials
• Literature reviews

Deliverables

• Study protocols and analysis plans
• Quality-controlled databases
• Statistical tabulations of data
• Study reports
• Regulatory reports
• Peer-reviewed journal articles
• Conference posters and presentations
• Lectures and short courses epidemiology and risk management

Related Services
For your projects that may have cross-functional requirements, we also offer the following complementary, epidemiology-related services:

• Biostatistics
• Pharmaceutical Risk Management
• Drug Safety and Pharmacovigilance