Study Design

Study Design

Study Design

Scientists at CD BioSciences are experienced in various types of study design in many different clinical areas such as central nervous system, cardiovascular, immunology, pediatric, oncology and hematology.

Our Services

CRF Design

The case report form (CRF) is a paper or electronic questionnaire specifically used in clinical trial research, and is a record of the clinical trial data. Poor CRF design will result in frequent database modification thus affecting the study timelines.

Our statistical experts will help you to develop a clear and comprehensible plan to build an appropriate, clear and precise case report form quickly.

Statistical Analysis Plan

The statistical analysis plan (SAP) describes the planned analysis of clinical trials. Compared to the protocol that outlines the analysis, the SAP is a technical document detailing the statistical techniques of research analysis.

CD BioSciences' statistical experts will help you to develop a clear and comprehensible plan to build tables, data and lists that analyze the dataset and prepare the plan.

Randomization Plan Design

Randomization is designed to "control" bias by all means. It prevents the selection bias and insures against the accidental bias.

Our statistical experts will help you to develop a clear and simple randomization plan to ensure its unpredictability and balance and thus reduce or eliminate bias.

ISS and ISE Study Designs

The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are important parts in clinical trials. The focus of ISS and ISE is on the overall understanding of the effectiveness and safety of the drug under study, based on a complete understanding of the results of drug research.

Our statistical experts will help you to develop a clear and logical ISS and ISE study to conduct a comprehensive analysis of the feasibility, safety and effectiveness of clinical research on the drug.

Adaptive and Bayesian Designs

Generally, the adaptive modifications may include: adjusting sample size, adjusting the distribution ratio of main materials among groups, increasing the treatment group, adjusting the overall design of the trial, changing the statistical method, changes in clinical trial results, variables, and so on. Bayesian statistics has penetrated various fields of medical research, including clinical trials, observational studies, diagnostics and screening tests.

For specific problems in these areas, our statisticians can provide you with detailed services.

Sample Size and Power Calculation

In the process of designing a research study, selecting adequate sample size and power calculation are key steps that need to be considered early. An adequate sample size uses resources and time in the most cost-effective manner and is essential to producing useful research findings. Power means the ability of study findings to detect an effect. It goes hand-in-hand with sample size.

Our statistical experts will help you to develop a simple and comprehensible strategy for sample size and power calculation. Under this goal, the design of sample size and power calculation for the various clinical trials constitutes most of our work.

We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you with timely and high-quality deliverables. At the same time, we guarantee the cost-effectiveness, completeness and conciseness of reports.

If you are unable to find the specific service you are looking for, please feel free to contact us.

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