Medical Device Clinical Test
We will manage necessary overall matters for clinical testing such as clinical trial protocol approval (alteration) for medical devices clinical testing implement, selection and contract to clinical trials institute following medical device characteristic, IRB(Institution Review Board) coordination of opinion, reporting for clinical test results and clinical trial monitoring ect.
- Consulting subject
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- Company that want to proceed with ‘Approval of Clinical trial protocol’ under Article 10 of Medical Device Act and Article 20 of Enforcement Regulations of the Medical Device Act
- Detail of consulting contents
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- Approval of Clinical trial protocol
- Developing Standard Operating Procedures (SOP) documents
- Selection and contract of institution conducting clinical trials
- Preparing clinical trial protocol
- Preparing Informed Consent Form(ICF)
- Preparing of Case Report Form(CRF)
- Preparing Data on clinical trial
- Submitting of Data on clinical trial
- Preparing Institutional Review Board (IRB) related documents and coordination of opinion
- Clinical trial execute
- Preparing a clinical trial monitoring report
- Preparing for Initial Meeting
- Preparing for Initial Meeting
- Clinical trial document(TMF/ISF) Management
- Clinical trial result report
- Data Management
- Review of Statistical Analysis Results
- Review of Clinical trial result report
- Approval of Clinical trial protocol
Procedure
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- Preparing Protocol
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- Designing Purpose and Method of Study
- Budget considerations such as a research fee
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- Submitting Protocol
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- MDFS approval
- MDFS approval
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- Concluding of a clinical trial
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- Writing contract with the Director of the Clinical Testing Organization
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- Progressing Clinical trial
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- Progressing Clinical trial
- Monitoring
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- End of clinical trial
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- Reporting completion and Writing Clinical Trial Reports
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- Reporting completion and Writing Clinical Trial Reports
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- Inspection
- Audit
