The US regulatory environment has evolved substantially since the federal government first started to regulating food production and drug development. The initial re...

The clinical trial ecosystem is undergoing a structural shift. What was once a relatively linear, site-centric model has evolved into a complex, globally distributed...

What is FDA’s Project Optimus? The FDA’s Project Optimus is a key step toward improving dose optimisation in oncology. Originally announced in 2021, the guidance...

Clinical research associates (CRAs) do not replace investigators, radiologists or central readers and they do not independently perform a medical interpretation of i...

AI output being correct doesn’t automatically equate to it being trusted. Some pharma companies that have been drawing on AI powered adverse event processing for a w...

Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) provides standardised criteria for evaluating changes in tumour burden in solid-tumour clinica...