Based on our clinical experience specializing in the development of treatments for
cardiovascular diseases such as hypertension, heart failure, ischemic heart disease,
and arrhythmia, we provide customized clinical trial solutions that reflect
the unique characteristics of each condition and the latest therapeutic trends.
Cardiovascular Disease Therapeutics
Cardiovascular diseases are a major group of chronic conditions with high mortality rates worldwide, encompassing diverse sub-categories such as ischemic heart disease, heart failure, hypertension, arrhythmia, and peripheral vascular disease. As these diseases require long-term treatment and preventive strategies, it is essential to conduct clinical trials based on scientific evidence and proven clinical efficacy.
The clinical development of cardiovascular drugs focuses on evaluating the drug’s direct or indirect effects on the heart and vascular system, and requires a design that includes composite evaluation indicators such as mortality, cardiovascular event rates, and hemodynamic changes. Patient selection and stratified analysis must consider heterogeneity in the target population, comorbidities, and variability in drug response due to concomitant medications, while implementing complex clinical trials involving long-term follow-up and repeated measurements.
Based on real-world clinical data and real-world evidence (RWE), biomarkers, and imaging diagnostic information accumulated in the cardiovascular field, we establish predictive models for treatment response and strategically design adaptive design and predefined subgroup analysis to minimize development risks.
Leveraging our accumulated expertise and hands-on experience in developing therapeutics for a wide range of cardiovascular diseases such as hypertension, heart failure, ischemic heart disease, and arrhythmia, we provide full-cycle clinical solutions. Taking into account the pathophysiological complexity of cardiovascular diseases, we design customized protocols that ensure both clinical significance and statistical validity. We scientifically design clinical trials from the initial strategic planning stage, including sample size estimation, setting evaluation variables, and segmenting target populations.
We design and execute clinical trials considering long-term follow-up observations, composite assessments centered on major adverse cardiovascular events (MACE), and stratified designs focused on high-risk groups to evaluate the safety and efficacy of cardiovascular drugs. Drawing on the expertise of medical doctors as well as professionals in pharmacy, nursing, biotechnology, and clinical statistics, we structure complex clinical data and analyze drug responsiveness and prognostic factors.
We integrate and analyze electrocardiograms (ECG), echocardiograms, biomarkers, pharmacokinetic/pharmacodynamic (PK/PD) information, and real-world data (RWD) to support data-driven decision-making, including treatment response prediction, subgroup analysis, and early termination decisions.
C&R delivers scientific and expert solutions throughout the entire cardiovascular drug development process, from clinical trial design and statistical strategy formulation to compliance with global regulatory standards and data interpretation.
clinical development with C&R Research.