Vendor 정보
기업명
MediRama
소재지
Floor 7, 74 Noryangjin-ro, Dongjak-gu, Seoul
기업유형
  • 임상 CRO
  • 컨설팅
홈페이지
https://www.medirama.co.kr/kr
매출액 규모
NR
인력현황
17
규제점검
ISO 9001
미제공
기타 보유인증 현황
-
특화/특장점

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

소개자료
임상CRO업체 제공서비스
Clinical Operation
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Medical Writing
제공
Statistics
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Data Management
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Regulatory Affairs
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Pharmacovigilance
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Vendor Management
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Consulting
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Feasibility Service
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Medical Monitoring
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Training and Education
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IT Solution
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CDISC data service
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Project Management
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컨설팅
컨설팅
제공
기타 서비스
국내외 데이터 보호 규정 및 기준 준수 인증 보유 여부
데이터 보호 규정_GDPR
미제공
데이터 보호 규정_21CFR11
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데이터 보호규정_기타 비고