EpidStrategies is founded on rigorous scientific principles that guide our research on complex health conditions. With a focus on pharmaceuticals, medical devices, nutritional products, and environmental chemicals, EpidStrategies consulting scientists aid clients in the conduct, evaluation, and interpretation of epidemiological studies. Our research frequently results in peer-reviewed publications and presentations at scientific conferences and is also used in numerous regulatory documents in the US and Europe.
Core Services
- Assisting clients in evaluating their need for epidemiological support
- Designing and implementing research studies
- Managing small and large data sets
- Conducting statistical analyses, meta-analyses, and pooled Individual Patient Data (IPD) analyses
- Conducting systematic literature reviews following established guidelines such as PRISMA, STROBE, and MOOSE
- Writing scientific manuscripts following the guidelines of the International Committee of Medical Journal Editors (ICMJE)
- Developing epidemiology sections for orphan drug applications, risk management plans, and other regulatory documents
- Designing, conducting, and analyzing basic clinical trials, as well as conducting post hoc analyses
- Providing training courses for clients in statistical software use and statistical methods and analyses
Research Study Development and Conduct
- Study protocol development
- Institutional Review Board applications
- Design of collaborative studies with US and international medical
centers - Study implementation and project management
- Conduct safety evaluations
Examples:
- Longitudinal study of RSV phenotypic characterization and time trends in hospitalization
- Cohort study of patients at high risk for CVD, including lipid-lowering therapy prescribing patterns, cholesterol levels, and CVD event rates
- Retrospective cohort of cold agglutinin disease patients: demographic and clinical characterization and risk of adverse events
- Health-care resource utilization and costs for Medicare-insured ESRD patients with arteriovenous grafts and fistulae
Software Tools
- Comprehensive Meta-Analysis (CMA)
- ArcGIS
- Epi Info
- R
- SAS
- SEER*Stat
- Stata
Databases Used
- Surveillance, Epidemiology, and End Results Program (SEER)
- National Health and Nutrition Examination Survey (NHANES)
- National Death Index (NDI)
- The Healthcare Cost and Utilization Project (HCUP)
- The Health and Retirement Survey
- CMS (Medicare) Claims
- U.S. Census Bureau's American Community Survey
- U.S. Renal Data System (USRDS)
- Optum database
- Assistance in collaborations with proprietary client databases
Data Management and Statistical Analysis
- Study design consultation
- Randomization scheme design
- Preparation of Statistical Analysis Plans
- Data management, including complex data linkages
- Conduct of statistical analyses, including:
- Linear and non-linear regression models
- Multilevel models for dependent data
- Pooled (IPD) analysis
- Analyses of complex sample survey data
Examples:
- Statistical analysis of cross-over trial evaluating nutritional products for glycemic control
- Systematic meta-analysis of arteriovenous fistulae patency
- Pooled IPD analysis of growth and tolerance of partially hydrolyzed whey infant formula
Critical Evaluations of Epidemiologic Data and Studies
- Systematic literature reviews and meta-analyses
- Risk of bias for internal validity
- Evaluating publication bias and heterogeneity
- Sensitivity analyses
- Technical comments to regulatory agencies and entities, including FDA and EFSA
- Targeted literature reviews
- Evidence-based causation analyses using Bradford-Hill criteria
- Evaluation of study design and limitations
