Service Providers
Service Providers
- Name of Company
- 주식회사 리서치멘토
- Address
- 서울특별시 성동구 연무장5가길 25, 905호, 909호
- Key Services
-
- Clinical CRO
- SMO
- Clinical Solution
- Consulting
- Decentralized Clinical Trial(DCT)
- Etc - 식품의약품안전처 인허가 위탁대행서비스
- 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.)
- 1회 이상 ~ 5회 미만
- ISO 9001
- Provided
- Status of Additional Certifications
- 기업부설연구소
- Key Strengths
-
당사는 건강기능식품을 중심으로 한 인체적용시험을 전문적으로 수행하는 CRO로서, 임상시험 설계 단계부터 결과 해석 및 규제 대응까지 전 주기 통합 서비스를 제공합니다. 임상시험 프로토콜 개발, 실시기관(Site) 선정 및 Feasibility 검토, 임상시험 운영(Vendor Management, IRB 서류 제출, 모니터링 등), 데이터 관리(Data Management), 통계 분석, 최종 결과 보고서 작성까지 임상시험 전 과정을 체계적으로 수행합니다. 또한, 식품의약품안전처(MFDS) 인허가를 목표로 한 임상 데이터 기반 규제 전략 수립을 강점으로 하여, Gap Analysis, 제출 문서 작성, 질의·보완 대응 등 과학적 근거와 규제 논리를 결합한 인허가 컨설팅 및 대응 서비스를 제공합니다. 당사는 임상, 통계, 규제 기능을 유기적으로 연계함으로써, 심사 관점에서 논리적 일관성과 자료 신뢰도가 확보된 결과물 제공을 핵심 경쟁력으로 합니다.
- Introduction Materials (Upload attachment)
Services Provided by Clinical CROs
- 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
Services Provided by SMOs
- 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
Clinical Solution Services
- 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
DCT Services (Decentralized Clinical Trials)
- 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 Services
- Consulting
- Provided
Etc
- Other categories
-
식품의약품안전처 인허가 위탁대행서비스