Clinical research is conducted to discover or confirm risk factors for diseases, new therapeutic indications, adverse reactions, and/or effects of a specific therapy (including gene or cell therapy), technique, medication, and/or medical device. The purpose of this type of research is to evaluate aspects of quality, efficacy, and safety of the product in human volunteers.
Our ebook "Basic Guide on Clinical Research Regulation" details each step of introducing new therapies, medications, and medical devices to the market, from pre-clinical phases to human trials, addressing the regulation involved.
The ebook explains the vital role of the key participants in the process – including researchers, institutions, and volunteers – in conducting these research studies. Additionally, it provides a clear overview of Bill 7,082/17, which aims to establish a legal framework for clinical research in the country, ensuring legal certainty and process simplification.
The publication highlights all relevant aspects of the topic:
- Research stages
- Regulation and approval
- Key participants
- Bill 7,082/17
