Clinical trial monitoring and quality assurance are pivotal elements in the successful conduct of clinical research. These processes ensure that trials adhere to regulatory requirements, maintain high ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s ...
Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...
As demand from sponsors and CROs for proven, large‑scale remote patient monitoring (RPM) capabilities continues to ...
Once diagnosed, age-related macular degeneration (AMD) needs to be regularly monitored for progression both before treatment or rehabilitation is initiated (to guide the initiation decision) and ...
Safety monitoring in clinical trials is a critical component of ensuring participant welfare and maintaining the integrity of study outcomes. Recent innovations have led to the adoption of systematic ...
In today's ACT Brief, we examine the technical and operational challenges of implementing risk-based monitoring across global trials, how AI must address social determinants of health and site burden, ...
Turning fragmented clinical data into actionable insight helps clinicians access unified patient information for faster, informed decisions across ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Quality of life (QOL), a measure of an individual's overall enjoyment of life, stands as an essential consideration for healthcare professionals conducting clinical trials. When evaluating the ...
SAN ANTONIO--(BUSINESS WIRE)--AirStrip®, a leader in advanced clinical monitoring and alarm management solutions, has announced the acquisition of DECISIO® Health, a provider of innovative clinical ...
Joe Kiani, Founder and CEO of Masimo, said, “We are grateful for the opportunity to collaborate with world-class organizations like UCHealth. By combining our technological expertise and their ...