When new drugs are approved, the marketing authorization holders often have to commit themselves to perform additional post-authorization studies. These studies have a different set up. Most countries have adjusted the regulations for studies where the drug is commercially available; although there is no "one fits all" concept.
21st Century Cures Act and Real-World Evidence
Exploring Real-World Outcomes
Our Embedded Solutions™ model helps clients execute their product portfolios more efficiently, with greater control, standardization, consistency,…