Strategy and Consulting
Mapi has experienced professionals to guide and support you in the development of your research program in epidemiology and pharmaco-epidemiology.
We help our clients to determine what type of information is needed and the most efficient and effective ways to collect disease occurrence, burden of illiness and healthcare resource use to support our clients' health-economic modeling and health technology reimbursement activities. These include:
- Advice on current health care payer requirements for epidemiology and real-world data
- Proactive design of our health-economic modeling and data-assembly activities to include recommendations about sources additional epidemiology and other real-world data to fill data gaps
- Study design and study conduct expertise related of all types of epidemiology and observational studies, including health care databases
- Provide payer liaison support and interaction (e.g., preparation, meetings, and responses to payer requests)
We collaborate with clients to strategically design peri- and post-approval programs to satisfy FDA, EMA, and other regulatory agency requirements for post-marketing surveillance while simultaneously supporting important clinical and commercial interests of the company.
- Review the overall regulatory submission strategy and help define an integrated approach to provide regulatory liaison support and interaction (e.g., preparation, meetings, and responses to regulatory authorities)
- Develop an integrated pharmacovigilance and post-marketing requirement study plan to address the requirements of various regulatory authorities
- Strategically design post-marketing requirement studies to address product safety and other important company interests
- Design and implement “bridging studies” prior to product approval (e.g., expanded access, safety extension, registries, Phase IIIb, large streamlined trials)
- Provide clinical, epidemiology, biostatistics, and analytical support