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Investigator’s Brochures are prerequisite documents for the submission of Clinical Trial Applications (CTAs) of Investigational New Drugs (INDs). They cover the entire development program of a drug, including preclinical and clinical studies. IBs compile study relevant data for investigators of regulatory agencies, such as EMA or FDA, and need to be updated regularly, as new information becomes available.
Handling applications including mandatory and comprehensive documentation for pharmaceutical drugs and/or medical devices is not only a day-to-day business for the consultants of IASON consulting, but it is our passion.
A key instrument to our success is our extensive experience within the process of drug and/or device application and approval processes. Our professional and independent team of IASON consultants provides high-quality strategic and operational input into drug and device development since 2004. We back-up every project with more than 150 years of combined experience due to our interdisciplinary team of toxicologists, pathologists, biologists, and veterinarians.
Investigator Brochures aim to maintain human safety throughout clinical trials and to provide the investigator with the necessary information for an unbiased risk-benefit assessment.
IBs by IASON consulting are written according to the most current regulatory requirements and guidelines of the U.S. Food and Drug Administration (FDA) and the International Conference of Harmonisation (ICH).
Document preparation and reoccurring reviews for submission in the European Union, Japan, and the United States are provided with the uttermost attention to current developments within the health care sector.
Please do not hesitate to contact us to find out more about services provided by IASON consulting