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 ...

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 ...

Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...

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 ...

Turning fragmented clinical data into actionable insight helps clinicians access unified patient information for faster, informed decisions across ...

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, ...

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 ...

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 ...

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As demand from sponsors and CROs for proven, large‑scale remote patient monitoring (RPM) capabilities continues to ...

Real-world data presented at HRS 2026 add to the body of evidence supporting a shift away from short-duration Holter monitoring toward up to 14 days of continuous, uninterrupted monitoring with Zio® ...