Clinical Research Design
From evidence-based clinical research design to outcome dissemination — we are with you every step of the way.
Dongsimwoo Bio possesses systematic clinical research design and execution capabilities for generating clinical medicine evidence. We utilize various research methodologies including randomized controlled trials (RCT), observational studies, and systematic reviews, and support the entire clinical research process from Institutional Review Board (IRB) preparation to statistical analysis and manuscript submission.
Research Expertise
Methodology
Research Methodology
We apply optimal clinical research methodologies based on the research objective and level of evidence.
Randomized Controlled Trial (RCT) Design and Execution
Systematic design of high-evidence clinical trials
We systematically design all phases of RCTs, from hypothesis formulation, randomization strategy design, sample size calculation, blinding strategy development, to statistical analysis plan (SAP) preparation. We also perform results reporting in accordance with the CONSORT guidelines and serve as the coordinating center for multi-center clinical trials.
Systematic Review and Meta-Analysis
The highest level of evidence-based medicine research methodology
We conduct systematic reviews and meta-analyses following the Cochrane Handbook. We perform the entire process including PRISMA guideline-based reporting, literature search strategy development (PICO), risk of bias assessment (RoB 2.0, ROBINS-I), heterogeneity analysis, publication bias testing, and quality of evidence assessment (GRADE).
Real-World Data (RWD)-Based Observational Studies
Electronic medical records and health insurance claims data analysis
We conduct retrospective cohort studies, cross-sectional studies, and case-control studies using real-world data such as electronic medical records (EMR), Health Insurance Review and Assessment Service (HIRA) claims data, and Korea National Health and Nutrition Examination Survey (KNHANES). We apply causal inference methodologies including propensity score matching (PSM), instrumental variable (IV) methods, and difference-in-differences (DID).
Medical Artificial Intelligence (Medical AI) Research
Convergence research of clinical medicine and artificial intelligence
We conduct Medical AI research including clinical data-based disease prediction models, medical image analysis (CT, MRI, X-ray), and natural language processing (NLP)-based electronic medical record analysis. We utilize methods ranging from traditional machine learning such as XGBoost and Random Forest to deep learning models (CNN, Transformer), and perform model validation following TRIPOD and PROBAST guidelines.
IRB & Ethics
IRB and Research Ethics Support
We provide systematic support from Institutional Review Board (IRB) review preparation to research ethics management.
IRB Review Document Preparation
Complete document package from research protocol to consent forms
We prepare the complete set of documents required for IRB review, including research protocols, informed consent forms (ICF), personal information processing consent forms, safety management plans, and vulnerable subject protection measures. We provide customized documents tailored to each institution's IRB review criteria and formats.
Research Ethics Compliance
Compliance with the Declaration of Helsinki and KGCP standards
We support research conduct in compliance with domestic and international research ethics standards including the Declaration of Helsinki, Korean Good Clinical Practice (KGCP), and Bioethics and Safety Act. We also handle post-approval IRB management including safety reporting (SAE/SUSAR), research amendment reviews, and annual reports during the research process.
Multi-Center Clinical Research Coordination
Simultaneous IRB management and research coordination across multiple institutions
We coordinate the individual IRB approval processes at each participating institution in multi-center clinical research. We support overall coordination for smooth multi-center research operations, including customized responses to differences in IRB formats across institutions, standardization of inter-institutional data management, and monitoring plan development.
Statistics
Statistical Analysis Services
We provide specialized statistical analysis for clinical research data.
Statistical Analysis Plan (SAP) Development
We prepare statistical analysis plans including primary and secondary endpoint definitions, analysis population definitions (ITT/PP), missing data handling strategies, and sensitivity analysis plans tailored to the research design.
Sample Size Calculation
We calculate the minimum required sample size based on the study design, statistical power, significance level, and expected effect size. We present the final sample size accounting for the expected dropout rate.
Survival Analysis and Longitudinal Data Analysis
We perform time-dependent data analyses including Kaplan-Meier analysis, Cox proportional hazards model, repeated measures ANOVA (RM-ANOVA), and mixed-effects models.
Statistical Reports for Manuscript Submission
We prepare statistical reports for manuscript submission that include statistical result tables, visualization materials, and analytical methodology descriptions compliant with study type-specific reporting guidelines such as STROBE, CONSORT, and PRISMA.
Process
Research Execution Process
We generate high-quality research outcomes through a systematic process from research planning to outcome dissemination.
01. Research Planning and Design
We conduct research topic exploration, literature review, hypothesis formulation, study design finalization, IRB application preparation, and research ethics review.
02. Data Collection and Management
We perform clinical data collection, CRF (Case Report Form) design, data entry and verification, and database lock procedures.
03. Statistical Analysis and Interpretation
We perform statistical analysis according to the SAP, clinical interpretation of results, additional exploratory analyses, and visualization material preparation.
04. Outcome Dissemination
We support SCI(E) journal manuscript submission, academic conference presentations, patent applications, technology transfer, and follow-up research planning.
Clinical Research Design Inquiry
We provide customized clinical research support from RCT design to IRB preparation and statistical analysis.
Let us guide you through our tailored solutions.