Epi Excellence LLC is an epidemiology consulting company that has expertise across an array of observational research and real world evidence (RWE) capabilities, including study design, literature review, evidence synthesis, data analysis, and results communication. We aim to understand our customers’ big picture goals and objectives, adding value via tailored solutions, with attention to detail and scientific rigor. Our extensive network affords access to experts across an array of medical, public health, market access, regulatory, data, and analysis fields.
Project and Staff Extension Services include:
- Providing seasoned expertise as a staff epidemiologist for a product or project
- Designing and conducting epidemiology studies of drug risk, drug effectiveness, or disease natural history, including administrative database studies and real world evidence (RWE) - from concept to analysis to presentation/publication
- Writing or editing study protocols, analysis plans, reports, abstracts/presentations/manuscripts, or regulatory communications
- Literature review to summarize and/or critique epidemiology literature (targeted or systematic)
- Medical or regulatory writing
- Document review, critique, or editing
- Ad hoc small tasks
Consulting services include:
- Epidemiology strategy and tactics to support global product development, commercialization, real world evidence (RWE), and regulatory strategy, from early development through post-authorization safety and/or effectiveness studies
- Regulatory strategy and defense (e.g., input to communication planning with global health authorities, serve as mock FDA panel or Advisory Committee member, serve as sponsor's external epidemiology expert in health authority interactions)
- Connection with a wide network of epidemiology experts and opinion leaders
- Seminars on epidemiology and pharmacoepidemiology methods, strategy, and case studies
- Expert review of and input to study documents (e.g., proposals, analysis plans, reports, manuscripts)
- Expert review and critique of published articles
- For observational research firms: pharmaceutical client perspective on proposals and deliverables
A fortune cookie divines a core goal of epidemiology.
+1 (610) 497-8918 info@epiexcellence.com