Leveraging our clinical experience in central nervous system (CNS)
disorders such as Alzheimer’s disease, Parkinson’s disease, multiple
sclerosis, and epilepsy, we provide customized clinical trial
solutions optimized for therapeutic development in this field.
CNS diseases encompass a wide range of neurodegenerative and psychiatric disorders, including Alzheimer's disease, Parkinson's disease, multiple sclerosis, and epilepsy. Due to the rapid progression of these diseases, the diversity of their symptoms, and their heterogeneous pathophysiology, they are considered one of the most challenging areas in clinical development. These diseases significantly impact quality of life, and the need for effective treatments continues to grow.
CNS drug clinical trials require long-term, precise observation due to the irreversibility of the diseases, the subjectivity of symptoms, and the influence of placebo effects, making patient recruitment and compliance management particularly challenging. From the initial design stage, it is necessary to clearly define patient groups reflecting disease-specific characteristics, and it is important to objectify evaluation indicators and set clinical indicators based on highly sensitive scales.
The use of imaging biomarkers, electroencephalography, and digital biomarkers is expanding in CNS disease clinical trials, enabling clear evaluation of treatment effects through quantitative analysis. We design clinical trials considering the specific characteristics of the disease and support reliable data interpretation using statistical techniques. Based on our experience in CNS clinical trials and understanding of global regulatory requirements, we perform adaptive design, interim analysis strategies, and subgroup analysis to increase the likelihood of clinical trial success.
Leveraging our expertise and hands-on experience in developing therapeutics for a wide range of central nervous system (CNS) disorders, such as Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and epilepsy, we provide full-cycle clinical solutions. By reflecting the unique clinical course and treatment response characteristics of each condition, we design protocols that ensure both statistical validity and clinical significance. From the earliest stages such as sample size calculation, subject group definition, and selection of assessment tools, we strategically design clinical trials. Drawing on the expertise of medical doctors and professionals in pharmacy, nursing, biotechnology, and clinical statistics, we plan and execute clinical trials with a disease-specific approach.
By integrating and analyzing CNS disease-specific evaluation indicators such as brain imaging, electroencephalography, and digital biomarkers, along with pharmacokinetic/pharmacodynamic (PK/PD) data, genomic information, and real-world data (RWD), we support treatment response prediction, subgroup definition, and interim analysis-based decision making.
C&R offers comprehensive and specialized services throughout the entire clinical development process, including data-driven analytical capabilities, clinical trial design, statistical strategies, regulatory compliance, and decision-making support, successfully guiding complex and challenging CNS drug clinical trials to success.