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)
Services Provided by Clinical CROs
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 Services
Consulting
Provided
Other
Compliance Certification Status for Domestic and International Data Protection Regulations
Data Protection Regulation_GDPR
Not Provided
Data Protection Regulation_21CFR11
Not Provided
Data Protection Regulation_others