Service Providers
- Name of Company
- ResearchMentor Co, Ltd.
- Address
- #905, #909, 25, Yeonmujang5ga-gil, Seongdong-gu, Seoul, Republic of Korea
- Key Services
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- Clinical CRO
- SMO
- Clinical Solution
- Consulting
- Decentralized Clinical Trial(DCT)
- Etc - MFDS Regulatory Strategy & Approval Support
- Homepage(English)
- https://www.researchmentor.co.kr/
- Sales(end of 2024)
- NR
- Human Resources Status
- NR
- Number of audit of Regulatory agency(ex FDA/EMA, etc.)
- 1 to 5 times
- ISO 9001
- Provided
- Status of Additional Certifications
- Certified In-house Research Institute
- Key Strengths
-
We are a specialized CRO focused on human clinical trials for health functional foods, providing end-to-end integrated services from study design through regulatory submission support. Our capabilities cover the full clinical trial lifecycle, including protocol development, site feasibility assessment and selection, clinical trial operations (vendor management, IRB submissions, and monitoring), data management, statistical analysis, and preparation of final study reports. In addition, we offer regulatory strategy and approval support aligned with MFDS requirements, leveraging clinical evidence to support approval pathways. Our services include gap analysis, preparation of submission documents, and scientific and regulatory responses to authority inquiries. By closely integrating clinical operations, biostatistics, and regulatory affairs, we deliver regulatory-ready clinical packages with strong data integrity and logical consistency, tailored to regulatory review expectations.
- Introduction Materials (Upload attachment)
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- Clinical Operation
- Provided
- Medical Writing
- Provided
- Statistics
- Provided
- Data Management
- Provided
- Regulatory Affairs
- Provided
- Pharmacovigilance
- Not Provided
- Vendor Management
- Provided
- Consulting
- Provided
- Feasibility Service
- Provided
- Medical Monitoring
- Provided
- Training and Education
- Not Provided
- IT Solution
- Not Provided
- CDISC data service
- Provided
- Project Management
- Provided
- Site Management
- Provided
- CRC Out-sourcing
- Not Provided
- Subject Recruitment
- Provided
- Subject Maintenance
- Not Provided
- Feasibility Study
- Provided
- IRB Reporting
- Provided
- Supporting Contract and Negotiation
- Provided
- Staff Training
- Not Provided
- Supporting Essential Document Management
- Provided
- Biostatistics
- Provided
- eCRF
- Provided
- E-Consent
- Not Provided
- ePRO/eCOA
- Not Provided
- EDC
- Provided
- CTMS
- Not Provided
- eSafety
- Not Provided
- IWRS
- Not Provided
- e-TMF
- Provided
- Virtual Data Monitoring
- Not Provided
- Other
- Online Subject Recruitment
- Provided
- E-Consent
- Provided
- IP (Investigational Product) Delivery
- Not Provided
- Remote Study (Remote Monitoring & Telemedicine)
- Not Provided
- In-home Research (Home Visits to the Subject’s Residence for Specimen Collection Including Blood Collection and Vital Sign Assessment)
- Not Provided
- Off-site Data Collection – Self-Collection of Specimens (e.g., Personal Diagnostic Kits)
- Not Provided
- Off-site Data Collection – Self-Measured Health Data (e.g., Personal Health Management Products, Wearable Devices, Medication Adherence Tools)
- Not Provided
- Cardiovascular Disease (CVD)
- Not Provided
- Diabetes / Endocrine Disorders
- Not Provided
- Respiratory Diseases
- Not Provided
- Sleep Disorders / Sleep Apnea
- Not Provided
- Obesity / Metabolic Syndrome
- Not Provided
- Medication Management (Electronic Pill Bottle, Recording Medication Intake, etc.)
- Not Provided
- Off-site data collection – self-report(ePRO/eCOA)
- Not Provided
- Remote Data Monitoring
- Provided
- Other
- Consulting
- Provided
- Other categories
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MFDS Regulatory Strategy & Approval Support