Pivotal study
This glossary item is used in the course Market Approval Online
Pivotal study
Clinical trial that is designed to provide the ultimate evidence and data that the authorities will use to decide whether to approve – or not – a candidate medicinal product. Also known as a phase 3 trial.
Market Approval Online
Market Approval is mandatory at various milestones in the development of your novel biomedical intervention and need to be passed to move your product to the market and beyond.