Guided by sound methodology, EpidStrategies scientists support the development of life sciences products through the design, execution, analysis, and evaluation of pharmacoepidemiology research studies. We promote scientific progress and discourse by communicating the implications of our studies to key internal and external stakeholders. EpidStrategies scientists frequently present study results to regulatory organizations such as the FDA, UK MHRA, EMA, and Health Canada and at scientific meetings and congresses. Our work has resulted in over 200 peer-reviewed publications.
Core Services:
- Design and conduct surveillance and natural history studies
- Characterize demographics, clinical characteristics, treatment patterns, outcomes, and healthcare utilization of target populations
- Calculate incidence and prevalence of specific disease conditions, including rare diseases
- Identify, manage, and analyze real-world datasets (e.g., primary data, electronic health records, Medicare, Medicaid, claims, and surveys)
- Develop epidemiology sections for orphan drug applications, risk management plans, clinical study reports, and other regulatory documents for FDA, UK MHRA, EMA, and Health Canada
- Conduct post hoc analyses for clinical trials
- Conduct systematic literature reviews and meta-analyses using standard methodology (e.g., PRISMA, STROBE, and MOOSE)
- Provide epidemiologic and statistical support throughout the product development pipeline