Epidemiology
REGISTRAT-MAPI specializes in providing strategic consulting and related services in Epidemiology and Product-Related Risk Management. This includes global observational studies, product safety and risk management plans, comparative effectiveness, pharmacoepidemiology, health outcomes and economic research analysis, and market forecasting.
REGISTRAT-MAPI applies Epidemiology expertise and services in the following areas:
- Disease and product registries
- Heath database studies
- Pregnancy registries
- Safety and pharmacovigilance
- Comparative effectiveness and pharmacoepidemiology studies including retrospective and prospective claims studies, with or without chart review
- Pharmacoeconomic modeling and analysis
- Patient reported outcomes
- Market forecasting
Observational Studies and Registries
Our services to conduct global and local country data sources include study design and development, protocol development, local regulatory knowledge, study setup, investigator and patient recruitment, case report form development, instrument selection, data collection, scientific oversight, adverse event reporting, statistical analysis plan development, data analysis, report writing and publication.
Health Care Database Studies
We are experts in the identification and use of health care databases and other accessible observational data in the USA, Europe and Asia. We help our clients identify the best data resources to meet their needs on a country and region specific basis. Our services include study design, protocol writing, statistical analysis, report writing and publication.
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, post-marketing surveillance plans, risk management plans (EU-RMP and REMS), literature reviews and publications. We also design and conduct Risk Management Plan development and effectiveness evaluation programs.
Health Outcomes and Economic Research
In collaboration with other Mapi Group companies, wee 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, comparisons of resource utilization, cost analysis and model development using different perspectives, costing methods and modeling approaches. We can develop cost-minimization, cost-benefit, cost-utility and cost-effectiveness analysis and develop Budget Impact Models using tools such as Markov models and decision tree.
Patient Reported Outcomes
In collaboration with other Mapi Group companies, we offer comprehensive consultation services in patient reported outcomes including Quality of Life, disease and treatment related symptoms, and physical functioning. Our services include consultation on scale selection as well as development, validation, and translation of new scales. Our analytic expertise includes multivariate statistical methods including cluster analysis, factor analysis, discriminant function analysis; generalized linear mixed models; and correlated data and missing data methods.
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.
Epidemiology Datasheet