Medical Affairs
MARACA International offers a unique service as Medical Practitioner
This includes:
- Physician input and review of the design of the product
- Advisor in the development of Companion diagnostic products
- Risk management review for patient impact
- Health Hazard assessment of a complaint for patient impact
- Risk-Benefit summary development and signing as Medical Practitioner
- Clinical evidence development from literature review and signing as Medical Practitioner
- Assessment of clinical evidence in the Performance evaluation report
- Clinical performance study protocol development
- On-market clinical study protocol development
- Clinical performance study synopsis as Medical Practitioner
- Statistical analysis plan with endpoints for clinical performance study
- Clinical performance study report writing and signing as Medical Practitioner
- Physician representation with FDA and competent authorities
With more than 20 years’ experience with these activities, we can provide you with unique service excellence. More detailed information and making a proposal?
