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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 programme of a drug, including preclinical and clinical studies. IBs contain study relevant data for investigators of regulatory agencies, such as EMA or FDA, and need to be regularly updated or as soon 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 also 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 has provided high-quality strategic and operational input into drug and device development since 2004. Every project is accounted for by more than 15 years of experience and by our interdisciplinary team of toxicologists, pathologists, biologists, and veterinary surgeons.
Unbiased
Investigator Brochures aim to maintain human safety throughout clinical trials and aim to provide necessary information for an unbiased risk-benefit assessment.
Current
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).
International
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.