Epidemiology
REGISTRAT-MAPI specializes in providing strategic consulting and related services in Epidemiology and Product-Related Risk Management. This includes market forecasting, health burden and economic assessments, pharmacoepidemiology, product safety and risk management plans, and the conduct of observational studies in Europe and the United States.
Our Epidemiologists provide expertise in study design and analysis, including sub-studies, data mining, risk/benefit evaluation, etc. Sub-studies may include nested case-control studies or studies done in population subsets where it is not feasible to collect data on the whole population (e.g., special assays or expensive tests).
Market Forecasting and Development
We help our customers to research the market for their products and execute activities to improve the acceptance of their products within that market. Our services include strategy development, market forecasting, market research, customer surveys, communication strategies and publications.
Health Technology Assessments
We help our customers to assemble information to demonstrate the novel and incremental value of their products to reimbursement authorities. Our services include strategy development, health burden assessments, cost of illness studies, disease models, literature reviews and publications.
Product Safety and Risk Management
We help our customers demonstrate the safety of their products and develop methods for reducing the risks of these products. Our services include strategy development, investigation of safety signals, pharmacoepidemiology studies using databases, Post-marketing Surveillance Plans, Risk Management Plans (EU-RMP, REMS, RiskMAP), literature reviews and publications.
Observational Studies and Registries
Our services include study design, local regulatory knowledge, setup, investigator and patient recruitment, data collection, adverse event reporting, data analysis, report writing and publication.
REGISTRAT-MAPI applies Epidemiology expertise and services in the following areas:
- Disease and product registries
- Retrospective and prospective claims studies, with or without chart review
- Pregnancy registries
- Natural history studies
- Study design consultation
- Pharmacoepidemiology studies
- Protocol development
- Patient reported outcomes
- Manuscript development
- Risk/benefit analysis
- Pharmacoeconomic modeling and analysis
- Structured literature reviews
- Meta-analysis