ISS and ISE Study Design Services for Clinical Trials

icon.highlightedarticle.dark R&D Last modified: 8 May 2023

CD BioSciences, a provider of comprehensive clinical trial services with over a decade of experience, recently introduces ISS and ISE Study Design services for clinical trials, including overall evaluation of effectiveness and overall evaluation of safety, helping scientists 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.

Offering a wide range of professional clinical services to the research communities, CD BioSciences aims to assist clients to gain maximum information from laboratory experiments and clinical trials. It places great importance on quality control and quality assurance with careful planning, efficient statistical analysis, and clear and concise reporting. In addition, its highly trained staff are capable to bring clarity and predictability to the design and analysis of research trials, and its advanced analytics and automated workflows increase efficiency and improve quality.

“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. To achieve that, the study design of ISS and ISE for the various clinical trials constitutes most of our work, including the overall evaluation of effectiveness services and overall evaluation of safety services.” said Helen James, senior scientist at CD BioSciences.

For instance, for the overall evaluation of effectiveness services, the clinical validity data of the target indication population of drug studied must be sufficiently complete. The effectiveness evaluation should consider a variety of factors, such as the characteristics of the test population, the relationship between efficacy and dosage, the method of administration, and the clinical significance of the results. In the study design of the trial, CD BioSciences takes multiple factors into account such as patient enrollment, study achievement, control group and endpoint selection for scientists to evaluate the effectiveness.

For overall evaluation of safety, CD BioSciences considers important safety analyses factors such as adverse reactions related to the pharmacological classification of the study drug, special adverse reactions (such as arrhythmia, prolonged QT interval), characteristics of the test population and exposure of the test group and the control group, relationship between adverse reactions and doses interval and duration of administration, and long-term medication safety. When making overall evaluation of a study, CD BioSciences will consider all the factors mentioned above, and make a comprehensive evaluation.

For more detailed information on ISS and ISE Study Design services or other related services, please visit our website.

About CD BioSciences

Based in the US, CD BioSciences offers a full range of clinical trial consulting, design, conduction, management, reporting and analysis services to advance clients’ clinical trial development needs. Its clinical trial services focus on the entire clinical trial lifecycle including bioanalytical lab testing, clinical pharmacology, first-in-human (FIH), proof of concept (POC), early phase trials, phase IIa trials, phase IIb-III trials, phase IIIb-IV trials, CDM analysis and reporting. CD BioSciences has provided professional support to local, national, and international clients.

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CD BioSciences

Locatedin the US, CD BioSciences has been providing a full range of clinical trial consulting, study design, conduction, management, data analysis and report writing services for over a decade. Professional... Read more

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