One of the newer areas in which the US Food and Drug Administration (FDA) is exploring its regulatory role is the use of artificial intelligence (AI) in digital ment...

Redefining Participant Support Through Global Contact Centres As clinical trials continue to expand across geographies and adopt decentralised and hybrid models, ens...

For all the innovation reshaping clinical research, one part of the process has remained stubbornly analog: the documents. Protocols, Statistical Analysis Plans (SAP...

Continuous monitoring of safety and efficacy data in clinical trials is a fundamental component of modern clinical research. Because monitoring is complex and involv...

There is a persistent gap between preclinical promise and clinical reality in oncology drug development. Two-dimensional cell culture systems derived from animal mod...

Self-administered injectable drug–device combination (DDC) products are entering a phase of accelerated therapeutic innovation. Demographic change, chronic disease t...