Investigator’s Brochure (IB)

The Investigator’s Brochure is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Includes a description of the drug formulation, a summary of toxicological and pharmacological effects, a summary of safety and effectiveness, and a description of possible risks and side effects. The IB must be updated whenever there is relevant new information about the drug.


Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.


The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.