Service Providers
Name of Company
DR Research
Address
3F, 97 Jungdao-ro, Songpa-gu, Seoul, Republic of Korea
Key Services
  • Clinical CRO
  • Central Laboratory(Central lab, Bio-analytical lab)
  • Consulting
Homepage(English)
https://drr.ai.kr
Sales(end of 2024)
NR
Human Resources Status
NR
Number of audit of Regulatory agency(ex FDA/EMA, etc.)
NR
ISO 9001
Provided
Status of Additional Certifications
DR Research Corporate Research Institute, Clinical Trial Sample Analysis Laboratory (GCLP)
Key Strengths

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.

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
Not Provided
Medical Monitoring
Provided
Training and Education
Not Provided
IT Solution
Not Provided
CDISC data service
Not Provided
Project Management
Provided
Services Provided by Central Laboratory
Sample analysis
Provided
Result Analysis/Report
Provided
Project Management
Provided
Method Development
Provided
Sample Management
Provided
Logistics
Not Provided
Biomarker (incl. Protein) expression analysis
Provided
Supporting precision medicine advise
Provided
Laboratory Kit preparation; packaging; maintenance
Not Provided
Sample kits, supplies, etc. management
Not Provided
Consulting Services
Consulting
Provided