Clinical Research is the most significant part of activities regarding the receipt of required approvals for product launch and Post-Market Surveillance in the development stage of Medical Devices. Performance of Clinical Research is a critical and costly process. Studies should be planned and managed with careful consideration. DeSia offers all services required for Medical Device Clinical Research with its expert team on Medical device legal regulations.
1. Development and Documentation of Clinical Research Strategy
2. Preparation of files for application to Ethics Committee (EC) and Ministry of Health (MoH)
3. Presentation of Ethics Committee applications and answering of related questions
4. Presentation of Clinical Research to Ministry of Health and answering of questions regarding the study
5. Project Management
6. Statistical Evaluation
7. Preparation of final Clinical Research Report.