Regulatory Outlook Medical Device Clinical Trials in Japan In an effort to globally harmonize medical device clinical trials, Japan has implemented new regulations on how to develop and conduct them.

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

A Swiss startup called Risklick has launched artificial intelligence software for clinical trials that the company claims can reduce development time and costs by as much as 35%, according to an April ...

A clinical trial protocol is the foundation of clinical research, detailing objectives, study design, eligibility, safety oversight, and data analysis. Its structure ensures consistency and ...

Recently, China's National Medical Products Administration (“NMPA”) released a new version of the Inspection Points for Clinical Trials of Medical Devices. This new rule replaces two previous versions ...

When discussing the future of clinical trials, people often focus on the promise of exciting new technologies, including artificial intelligence (AI) and predictive modeling. However, even the most ...

When a physician runs a clinical trial, he or she becomes the principal investigator (PI). This role involves making medical decisions, providing adequate care to study patients according to the ...

Decentralized Clinical Trials Market OverviewThe global decentralized clinical trials (DCTs) market is witnessing strong ...

A large-scale clinical trial has determined that a specific brain stimulation device, previously cleared by regulators for treating attention-deficit/hyperactivity disorder, does not effectively ...