Global C&R
       
          Global C&R
           
          CNR Research, a key partner in global new drug development
          • CNR Research provides solutions optimized for global standards,
            such as the US FDA and European EMA, and multinational clinical trial
            operations based on its unique experience and capabilities as
            a leader in the South Korean clinical trial industry.
          • Leveraging Korea’s exceptional clinical trial environment and
            C&R’s distinct competitive advantages, we are committed to being
            a trusted partner to pharmaceutical and biotechnology companies worldwide.
          Extensive experience
          in multinational clinical trials

          With 52 outbound* projects and 45 inbound* projects , CNR Research has successfully conducted numerous multinational clinical trials, demonstrating its exceptional ability to respond flexibly to complex country-specific regulations and diverse clinical environments. All processes are supported by strict standard operating procedures (SOPs) and a systematic quality management system to ensure high-quality clinical results.

          *Outbound: Overseas expansion of Korean companies *Inbound: Korean market entry of overseas companies
          Global Regulatory Understanding
          and Approval Experience

          With over 20 years of RA (regulatory affairs) experience, our team of experts is well-versed in the rigorous approval processes of major global regulatory agencies such as the US FDA and European EMA. From pre-IND clinical trial protocols to IND submissions, IB, CTD, and IMPD documentation, as well as orphan drug designation (ODD) applications, the expertise we have accumulated through close collaboration with global regulatory agencies is a unique strength that enables us to provide stable and efficient regulatory support to our clients.

          Organic Services through
          a Multinational Network

          CNR Research provides organic and integrated services throughout the entire new drug development cycle through close collaboration with its subsidiaries and multinational affiliates. Rapid patient recruitment is possible thanks to quick patient access utilizing Korea's excellent clinical infrastructure, and clinical data is processed accurately and efficiently through thorough data management and biostatistical capabilities.
          Additionally, through a team of medical professionals led by Medical Doctors within the clinical development department, we offer comprehensive medical writing and regulatory services, including medical consulting and the preparation of clinical study reports (CSRs), across the entire development cycle. This enables us to deliver accurate, efficient, and high-quality clinical results that global sponsors can trust, thereby enhancing satisfaction.

          Global Clinical Trials
          Project Organization Structure
          C&R Global Worldwide Reach
          Study Experience
          Outbound
          C&R as a central CRO (PRT, CO, PV, DM, STAT, CSR) / local PM reporting to C&R GPM
          Inbound
          C&R as a local CRO (CO, PV, RA) / C&R local PM reporting to central CRO or Global sponsor
          Sponsor Indication Phase Country
          D Breast Cancer 2/3 Korea, China, Bulgaria, Hungary, Serbia
          D Breast Cancer 2 US, Czech
          B Smoldering Multiple Myeloma 2 China
          G Alzheimer’s Disease 2 Australia
          S Solid Tumor 1 Korea, US
          P AML 1 Korea, Spain, Australia
          R Solid Tumor 1 Bulgaria
          Y Antibiotics 2 China
          G Covid-19 1/2 Korea, US
          N Alzheimer’s Disease 2 Korea, US
          N Obesity 2 Korea, US
          N Solid Tumor 1 Korea, US
          Y Antibiotics 1 China
          G Covid-19 2 Korea, US, Bulgaria, North Macedonia
          J NASH 2 Korea, US
          I Becker Muscular Dystrophy 2 Korea, US
          I Duchenne Muscular Dystrophy 2 Korea, US
          R Wet AMD 3 Korea, US, Russia, Europe (5 countries)
          C Ulcerative Colitis 2 Korea, Bosnia, Serbia, North Macedonia
          S Atopic Dermatitis 1/2 Korea, US
          N Alzheimer’s Disease 2 Korea, US
          M Obesity 2 Korea, US
          I Advanced Tumor 1 Korea, US
          I Atopic Dermatitis 1/2 Korea, US
          T Diabetes, Hypertension 3 Korea, Thailand
          S Solid Tumor 2 Korea, US
          Sponsor Indication Phase Country
          T NASH 2 US
          N Obesity 2 Korea, US
          N Alzheimer's Disease 2 Korea, US
          A Solid Tumor 1 Korea, US
          I Solid Tumor 1 Korea, US
          S Gastrectomy Medical Device Korea, US, JP
          D Breast Cancer 3 Korea, US
          I Pancreatic Cancer Medical Device Korea, US
          D Hypertension 3 Korea, Thailand
          R nAMD 3 Korea, US, Europe
          D T2DM IIT Indonesia
          E Osteoarthritis Of Knee 3 US
          I Atopic Dermatitis 1/2 US
          D Hypercholesterolemia Medical Device US
          W Breast implant rupture Medical Device US
          A Obstructive Sleep Apnea Medical Device US
          D T2DM 3 Korea, Indonesia
          C Subarachnoid Hemorrhage 1/2 US
          N Obesity 2a US
          E CMT 1b US
          I Solid Tumor 1 US
          E CMT IIT US
          S Varicella 3 Philippines, Mexico
          B Type 2 DM & Essential Hypertension 3 Korea, Indonesia
          D Gastric Ulcer 3 Korea, Indonesia
          A Insomnia Medical Device US
          Sponsor Indication Phase
          B COPD 3
          B NSCLC 3
          N Gastrointestinal Stromal Tumor 3
          G Lung Cancer 2
          B Asthma 3
          N Chronic Myeloid Leukemia 2
          B Stroke 3
          G COPD 2
          G COPD 2
          G Pancreatic Cancer 2
          B Type 2 DM 2
          B Lung Cancer 2
          G Asthma 3
          G SLE 3
          G SLE 3
          G SLE 3
          B Pancreatic Cancer 2
          M Covid-19 Others
          F NASH 2
          M Covid-19 PMS
          M Covid-19 Others
          Q Solid Tumor 1/2
          B Kidney Disease PMS
          Sponsor Indication Phase
          M Severe Malaria 1
          T Solid Tumor 1
          M Chronic Pulmonary Aspergillosis 2
          R Cushing Syndrome PMS
          M Covid-19 PMS
          M Covid-19 PMS
          E TBD IIT
          F Chronic Renal Disease PMS
          M Infectious Disease PMS
          A Non–Cystic Fibrosis Bronchiectasis 2
          S Breast Cancer 1
          D Acute Myeloid Leukemia (AML) PMS
          A Storage Symptoms PMS
          D Breast Cancer PMS
          L Migraine PMS
          B Idiopathic Pulmonary Fibrosis PMS
          B TBD PMS
          B Type 2 DM & Essential Hypertension 3
          L Generalized Pustular Psoriasis (GPP) PMS
          A Advanced Solid Tumors Harboring c-MET Dysregulation 2
          B MCL PMS(OS)
          N Haemophilia PMS
          Global Footprint
          2015 Global clinical trialPM role 2020 Clinical trialin Australia 2021 FDA-linked multi-ethnicclinical trial at Seoul National University 2022 2024 2025 2026 Simultaneous Phase 3 clinical trials in Korea, the US, and six European countries 2023 Established subsidiaries in the USand Thailand; started FDA-linked clinicaltrials in the US; selected as APAC’s leadingclinical trial service company (TI Image) Clinical trials in Southeast Asia First multi-country productapproval (NDA) obtained;First FDA IDE approvalfor a medical device Office established in Indonesia 2015 2020 2021 2022 2023 2024 2025 2026 Global clinical trial PM role Clinical trial in Australia FDA-linked multi-ethnic clinical trial at Seoul National University First multi-country productapproval (NDA) obtained;First FDA IDE approvalfor a medical device Established subsidiaries in the US and Thailand; started FDA-linked clinical trials in the US; selected as APAC’s leading clinical trial service company (TI Image) Simultaneous Phase 3 clinical trials in Korea, the US, and six European countries Clinical trials in Southeast Asia Office established in Indonesia
          Global Networks
          Head Office
          South Korea

          Seoul

          Regional Office
          South Korea

          Busan

          United States

          Boston

          Singapore

          Singapore

          Thailand

          Chiang Mai, Bangkok

          Thailand

          Chiang Mai, Bangkok

          • Global Clinical & Regulatory Expertise
            • FDA IND Approval
            • FDA IDE Approval
            • TFDA Clinical Trial Approval
            • CREC Ethics Committee Approval
            • Global Clinical Trial Planning & Management
            • Multinational & Multi-Site Clinical Trial Management
          • Global Network & Partnerships
            • US-Based PM & Clinical Operations Hub
            • US Regulatory Affairs Network
            • Indonesia CRO Partnerships
            • Thailand Clinical Research Network
            • Vietnam CRO Partnerships
            • AI-Powered Clinical Data Platform
          • Growth Strategy & Execution Support
            • Clinical Development Strategy
            • Regulatory & Development Planning
            • Global Market Access Support
            • Indication Expansion
            • Business Growth
            • Government-Funded R&D Planning
          Turning complex development challenges into actionable strategies for global expansion.