• 임상 CRO
• 검체분석기관
• 컨설팅

DR Research Co., Ltd. is a contract research organization (CRO) specializing in medical devices, in vitro diagnostic (IVD) devices, pharmaceuticals, and health functional foods. We also operate a clinical trial sample analysis laboratory designated by Korea’s Ministry of Food and Drug Safety (MFDS). 1. End-to-end integrated support: We provide integrated services throughout the product development lifecycle, from development strategy, clinical studies, and clinical trial sample analysis to regulatory approval and post-approval market access. 2. Tailored development and regulatory strategies: We develop strategies for clinical evidence generation and regulatory approval based on each product’s intended use, development stage, target markets, and applicable regulatory requirements. 3. Comprehensive clinical study support: We support clinical trials for medical devices and pharmaceuticals, clinical performance studies for IVD devices, human intervention studies for health functional foods, and clinical research in advanced regenerative medicine. Our services include study design, site selection, monitoring, data management, statistical analysis, and study report preparation, tailored to the requirements of each study. 4. Specialized clinical trial sample analysis: Supported by our GCLP-based quality management system and analytical infrastructure, we provide bioanalysis for pharmacokinetic evaluation, LC-MS/MS analysis, clinical laboratory testing, immunoassays, and nucleic acid analysis. 5. Post-approval market access support: For medical devices, we develop market access strategies and support the preparation of documentation for new health technology assessment, reimbursement applications, and adoption by healthcare institutions.