With clinical experience specialized in endocrine disorders
such as diabetes, obesity, adrenal, and thyroid diseases,
we provide customized clinical trial solutions optimized
for therapeutic development.
Endocrine Disorder Therapeutics
Endocrine disorders are a major group of chronic diseases whose prevalence continues to rise worldwide, including diabetes, obesity, adrenal dysfunction, and thyroid diseases. They originate from complex abnormalities in metabolic and hormonal regulation and can lead to various systemic complications, such as cardiovascular, neurological, and immune system disorders, over the long term. Demand for the development of effective and safe therapeutics is growing, and the need for scientific and precise clinical development strategies is becoming increasingly critical.
In the early stages of clinical trials, careful planning is essential, from defining patient populations and establishing inclusion/exclusion criteria. We design realistic clinical trials using real-world data (RWD) obtained from actual medical settings and verify that the assumptions made in the design are valid in a clinical environment.
Leveraging accumulated data across various endocrine disease areas, we provide clinical development strategies such as appropriate statistical analysis plans, biomarker-based subgroup analyses, and adaptive clinical trial designs.
Furthermore, through documentation and result interpretation aligned with the guidelines of regulatory authorities in each country, we support competitive clinical development in the global new drug development environment.
Leveraging our accumulated expertise and hands-on experience in developing therapeutics for a wide range of endocrine disorders such as diabetes, obesity, adrenal, and thyroid diseases, we provide full-cycle clinical solutions. By incorporating disease-specific pathophysiology and the latest treatment paradigms, we design protocols that ensure both clinical relevance and statistical validity. From the earliest strategic stages, including sample size calculation, target population definition, and key evaluation variable setting, we provide systematic support. Drawing on the expertise of medical doctors as well as professionals in pharmacy, nursing, biotechnology, and clinical biostatistics, we plan and execute clinical trials with a disease-specific approach.
We integrate and analyze real-world data (RWD), biomarkers, pharmacokinetic/pharmacodynamic (PK/PD) information, and genome-based data to predict treatment responses and perform subgroup analyses, providing reliable interpretations through accurate analysis of complex data.
C&R offers comprehensive and strategic services, including data analysis capabilities, clinical design, statistical strategies, regulatory compliance, and decision support, to professionally guide all stages of clinical trials for endocrine disease treatments.
clinical development with C&R Research.