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Validation

Validation

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Data validation is an activity verifying whether a combination of values is a member of a set of acceptable combinations based on certain rules that express the acceptable combination of values. If data satisfy the rules, data are considered valid for the intended use.

Bioassay validation is to evaluate and document the quantitative performance of an assay, including sensitivity, specificity, accuracy, precision, detection limit, range and limits of quantitation. In order to conduct full assay validation, you need to take into consideration both inter-assay and inter-laboratory assessment of assay repeatability and robustness.

CD BioSciences can make sure that your assay validation is conducted under the appropriate regulatory guidance in all of its statistical aspects, such as design and analysis.

Our Services

Data Validation

We provide data validation services for our clients' raw data. We validate the data by adopting validation rules tailored for the projects of our clients. Our data validation services will help our clients conduct their data analysis without concerns of poor quality of the data. Besides, we also offer independent validation of tables, listings, and figures.

Bioassay Validation

Our experts can offer:

  • Statistical analysis or consulting service on sensitivity, specificity, accuracy, precision, detection limit, range and limits of quantitation based on USP & ICH guidelines;
  • Review of sample size to meet regulatory requirements;
  • Drafting or review of the statistical methods sections used for validation protocol;
  • Preparation of statistical analysis plan and statistical analysis report.

Tailored to Clients’ Standards

Our statistical experts will communicate with clients based on their attributes, behaviors, needs, and other factors, and provide targeted statistical services based on their experimental purposes and methods.

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 cost-effective, complete, and concise reports.

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

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