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Clinical

Clinical

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To be competitive in today’s challenging economic, regulatory, and political environment, drug sponsors must reduce product development time, terminate unpromising candidates sooner, improve patient-recruitment capabilities, enhance the protocol design process, control development costs, maintain quality, focus on areas of high therapeutic need, and dramatically boost productivity. CD BioSciences’ experts could help you through all clinical phases in all statistical aspects.

Our Services

Study Design

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

With concerted efforts, our scientists will develop a clear and comprehensible plan to build an appropriate, clear and precise case report form quickly.

PK/PD Analysis and Modeling

PK/PD-modeling links dose-concentration relationships (PK) and concentration-effect relationships (PD), thereby facilitating the description and prediction of the time course of drug effects resulting from a certain dosing regimen. During drug development, they will provide valuable support to make important decisions.

The following services are provided for PK/PD analysis and modeling at different stages of drug development.

Interim Analysis

In clinical trials and other scientific studies, interim analyses are often performed before the completion of the trial, and the intention of this analysis is to determine whether the trial is terminated prematurely or to adjust the sample size.

CD BioSciences can provide completely independent analysis, keeping the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project.

Survival Analysis

Survival analysis originated from biomedical research, and the endpoint of the study was “survival and death” (hence the name survival analysis). Survival analysis is also currently widely used in economics, engineering, and sociology, which is also known as historical event analysis and failure time analysis.

Our statistical experts will select the appropriate survival analysis method based on the cost, operational feasibility and data type provided, making your tasks easier and more efficient.

Adaptive Clinical Trial Analysis

Adaptive clinical trial refers to an experimental design that modifies some aspects of the experimental design dynamically after the clinical trial starts, according to the information accumulated in the trial and without damaging the validity, scientificity and integrity of the trial.

Our experts will analyze various factors and select appropriate statistical methods to help you complete the analysis of adaptive clinical trial.

Bioequivalent Trial and Biosimilar Trial Analysis

Due to the increasing cost of drugs in clinical treatment in recent years, generic equivalents of –brand-name drugs have been introduced in the global market to alleviate the problem. And biosimilars are the biomedical products that are almost identical to the original drug produced by another company. Biosimilars must maintain consistent quality and clinical performance throughout their life cycle with the original product.

The services that we can provide in the analysis of bioequivalence and biosimilar are as follows.

IXRS Validation

With the rapid development of mobile intelligent terminals and cloud computing, interactive voice/web response systems (IXRS) are rapidly evolving as a new field. More new requirements on linguistics, emotional shaping, and logical construction have been proposed for the user experience. The interactive voice/web response system service we provide will work as follows.

Biomarker Validation

Biomarker validation is the process testing the accuracy, consistency, and ability of the biomarker in measuring, representing, and/or predicting the interested normal biological processes, pathogenic processes, or pharmacologic responses to therapeutic interventions.

CD BioSciences provides biomarker validation services to test the sensitivity, specificity, analytical validity, and clinical validity of candidate biomarkers of our clients.

SDTM Conversion Programming & Validation

The SDTM (Study Data Tabulation Model) is a standard for human clinical trial (research) data tables and non-clinical data tables submitted by researchers to FDA and PMDA (Japan).

Our experts will simplify the process of converting from SDTM/ADaM to NDA electronic submission, standardize data goals, ensure consistency of attributes for each variable between data sets, define files and programming specifications, and avoid waste of time and resources to verify late consistency.

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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