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사람의
사람에 의한
사람을 위한 가치 창조
인투인월드는 2015년에 설립되어
다년간의 임상 시험 분야에 종사한 전문가들이
모여, 인재 육성을 통한 임상시험 분야의
성장을 도모하고자 설립한
임상시험수탁기관(CRO)입니다.
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SET UP
- Protocol/CRF/ICF Development & Review
- Study Material Development
- Investigator’s Meeting
- MFDS/IRB Submission & Approval
- Feasibility Interview & Reporting
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MONITORING
- Monitoring Plan
- Initiation Meeting
- Essential Document Management
- Clinical Supply Management
- Regular Monitoring/SDV
- Close-out Monitoring
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PROJECT MANAGEMENT
- Project Management Plan
- Study Personnel Training
- Overall Management
- Clinical Trial Report
- AE/SAE Report
- IP Handling
- Site Management
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REGULATORY AFFAIR
- MFDS IND Approval
- MFDS NDA Approval
- IRB Affair
- Regulatory Consultation
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DATA MANAGEMENT
- Data Management Plan
- Database Design
- Data Entry
- Data Verification & Validation
- Medical Coding
- Data Locking
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STATISTICAL ANALYSIS
- Statistical Analysis Plan
- Programming & Analysis
- Generating Tables & Figures
- CSR Body & Translation
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MEDICAL WRITING
- Protocol
- Informed Consent Forms
- Clinical Study Reports
- Common Technical Documents (CTD)
- Clinical Sections of New Drug Applications (RA)
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QUALITY ASSURANCE
- Audit Plan
- Audit Report
- SOP Development & Management
- Good Clinical Practice Auditing
- Good Clinical Laboratory Practice Auditing
- Good Pharmacovigilance Auditing
- Due Diligence
- Vendor-Contractor Management
- Audit CAPA Management
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PHARMACOVIGILANCE
- SAE Processing
- Safety Report Production
- SAE/SUSARs Reporting to Regulatory Authorities
- SAEs Reconciliation
- SUSAR (Suspected Unexpected Serious Adverse Reaction)
- Handling
- Development and Maintenance of Pharmacovigilance
- Management and Maintenance of Safety Database
- Pharmacovigilance Training
- Program Development
- SMP (Safety Management Plan)
- RMP (Risk Management Plan)