Service Providers
- Name of Company
- MediRama
- Address
- Floor 7, 74 Noryangjin-ro, Dongjak-gu, Seoul
- Key Services
-
- Clinical CRO
- Consulting
- Homepage(English)
- https://www.medirama.co.kr/kr
- Sales(end of 2024)
- NR
- Human Resources Status
- 17
- Number of audit of Regulatory agency(ex FDA/EMA, etc.)
- ISO 9001
- Not Provided
- Status of Additional Certifications
- -
- Key Strengths
-
MediRama is an oncology-specialized CRO led by Dr. Hanlim Moon. Backed by a robust Medical Science team and Project Management team, we provide comprehensive services ranging from Clinical Development Plans (CDP) to full-scope clinical trials for clients targeting the global market. In the early development stages, we support pipeline development planning and strategy. Following this, we directly provide services across the entire spectrum of clinical trials, including MFDS/US FDA regulatory consulting, domestic clinical trial execution and site management, global project management (collaborating with overseas CROs for international site management), Pharmacovigilance (PV), and CSR writing. Additionally, through collaboration with our partners, we offer services such as Data Management, Statistical Analysis, Central Lab services, Investigational Product (IP) logistics, PK/PD analysis, and Biomarker analysis. Key Strengths of MediRama: - Oncologist CEO (Dr. Hanlim Moon) - Strong Medical Science Team - Strategic Business Partnership Approach - Extensive Personnel with Global Clinical Trial Experience - Timeline-Focused Clinical Strategy Development - Streamlined Project Management via a Single Dedicated
- Introduction Materials (Upload attachment)
- Clinical Operation
- Not Provided
- Medical Writing
- Provided
- Statistics
- Not Provided
- Data Management
- Not Provided
- Regulatory Affairs
- Provided
- Pharmacovigilance
- Provided
- Vendor Management
- Provided
- Consulting
- Provided
- Feasibility Service
- Provided
- Medical Monitoring
- Provided
- Training and Education
- Provided
- IT Solution
- Not Provided
- CDISC data service
- Not Provided
- Project Management
- Provided
- Consulting
- Provided
- Other
- Data Protection Regulation_GDPR
- Not Provided
- Data Protection Regulation_21CFR11
- Not Provided
- Data Protection Regulation_others