Shannon Spanhake

By Jackie Rubel | September 25, 2018

Global Effort to Overhaul Regulatory Framework for AI Medical Devices

Clinical Research NewsData routinely captured to track health and measure wellness do not reflect ground truth, as is well known in the field of medical informatics. That imperfect healthcare data [...]

The Scope of Things: Source Preparation Emerges as a Clinical Trial Startup Bottleneck

Clinical Research News | Clinical trial startup delays are often attributed to budgets, contracts, and regulatory review, but a less visible bottleneck may occur at the investigative site level: source [...]

FDA's Real-Time Clinical Trials Initiative Takes Shape: What Near-Live Data Sharing Means for Sponsors and Operations

Clinical Research News | The FDA's Real-Time Clinical Trials (RTCT) initiative is testing whether earlier access to selected clinical trial data can improve regulatory oversight by allowing reviewers to observe [...]

FDA's Real-Time Clinical Trials Initiative Takes Shape: What Near-Live Data Sharing Means for Sponsors and Operations

Real-Time Clinical Trials Need a Human Exception Log

Clinical Research News | Clinical research is getting faster. The FDA’s Operation TrialBlazer is explicitly aimed at accelerating and modernizing clinical development, while the agency has also been building toward [...]