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Clinical development planning
MIC started its services as a regulatory affairs consultant for medical devices 18 years ago. During its 18 years, it has accumulated a wealth of knowledge and experience in approval application of new medical devices such as disposables, implants, electrical medical devices, dental materials. MIC has staffs with various specialties in chemistry, pharmacology, biology, medicine, and electrical engineering. They can provide comprehensive regulatory support based on experiences and specialties.
•Selection of clinical trial sites
•Preparation of clinical trial protocol
•Collection of non-clinical test data and product development information required for notification of a clinical trial
•Preparation of documents for internal Institutional Review Board (IRB) and support for IRB meeting
•Preparation of documents for IRB at investigational sites
•Coordination and implementation of a clinical trial contract with investigational sites
•Preparation of notification of a clinical trial
•Preparation and/or support for responding to deficiencies from the Pharmaceuticals and Medical Devices Agency (PMDA) concerning the notification of the clinical trial
•Preparation of materials, coordination, and support for doctors' investigational meetings at start, for case review and for finalization of cases
•Monitoring at clinical site
•Data collection, statistical analysis
•Preparation of draft of a clinical report
