In the current pharmaceutical environment, where the industry faces a potential patent cliff ranging anywhere from $236–400B in revenue,1,2 sponsors are under mounti...

In September 2025, Spain’s national medicines agency, AEMPS, announced a significant regulatory change: the expansion of its fast-track assessment procedure to inclu...

Independent Data Monitoring Committees (IDMCs) have become an essential part of drug development. Not every clinical trial needs to have an IDMC, but the number of t...

Even before the boom of AI following the launch of generative AI platforms in 2022, AI was already reshaping clinical research and drug development, with early adopt...