About the Clinical Trials
Frequently Asked Questions
What is a clinical study?
According to the International Council for Harmonisation Good Clinical Practice (ICH GCP E6(R2)), a clinical study is any investigation in human subjects intended to discover or verify the clinical and/or pharmacological effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. Thus, a clinical study is an investigation in human subjects with the main goal to evaluate the efficacy and safety of the investigational product.
A successful clinical study is proof of the efficacy and safety of the investigational product; therefore, clinical studies are always an integral part of the drug development.