Leveraging extensive clinical development experience across
a wide range of tumor types, including solid tumors and hematologic
malignancies, we provide tailored clinical trial solutions that incorporate
the distinct characteristics of mechanism-specific therapies and the latest treatment strategies.
Clinical Development
Oncology diseases present complex and unpredictable pathophysiology due to the genetic and molecular biological heterogeneity of cancer cells as well as immune evasion mechanisms. These diseases rank among the leading causes of death worldwide. It is essential to establish clinical strategies that take into account the diverse subtypes of tumors, from solid cancers to hematologic malignancies, and the individual variability in treatment responses.
The clinical development of oncology drugs involves complex decision-making regarding treatment response assessment and toxicity management. This requires setting appropriate evaluation time points, tumor response criteria (e.g., RECIST), and survival-based indexes such as Progression-Free Survival (PFS) and Overall Survival (OS). From early development stages, we consider the biomarker status, genetic profile, and stage of the patient population, and support customized clinical design based on various treatment mechanisms, such as combination drug therapy, immune checkpoint inhibitors, and targeted therapies.
By integrating diverse data sources, including pharmacokinetic/pharmacodynamic (PK/PD), immune response, and tumor microenvironment analyses, we evaluate both therapeutic efficacy and tolerability. We leverage interim analyses and adaptive designs to enhance the efficiency of clinical studies.
To enhance the applicability of the trials in real-world clinical settings, we incorporate Real-World Data (RWD) and patient-reported outcomes (PROs) into the clinical trial design.
Leveraging extensive expertise and hands-on experience accumulated through the development of therapies for a wide range of oncology indications, including solid tumors and hematologic malignancies, we provide end-to-end clinical solutions. We design protocols that ensure clinical significance and statistical reliability by reflecting the mechanisms of treatment agents, such as immuno-oncology drugs, targeted therapies, and antibody-drug conjugates (ADCs), and the molecular biological characteristics of tumors.
From the earliest strategic stages, we offer integrated consulting covering patient population definition, biomarker-based subject selection, and the choice of evaluation endpoints.
Drawing on the collective expertise of medical doctors and specialists in pharmacy, nursing, biotechnology, and clinical statisticians, we efficiently manage complex oncology clinical trials.
By employing adaptive trial designs, interim analyses, and the integration of Real-World Data (RWD), we maximize the efficiency of clinical trials while enhancing the likelihood of regulatory approval through documentation and interpretation aligned with global regulatory standards. We conduct clinical trials by linking various data sources, including pharmacokinetics/pharmacodynamics (PK/PD), tumor response indicators (RECIST, etc.), and genomic and immune profiles.
C&R provides scientific and specialized solutions across all stages of oncology clinical trials, encompassing data analysis and statistical strategy, regulatory engagement, and decision-making support.
clinical development with C&R Research.