FDA Update on ICH E6, E8, QbD and RBM in Clinical Trials
Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) approaches in clinical […]
Revolutionizing Clinical Trials: The Power And Potential Of Risk-Based Monitoring
The article explores the benefits and misconceptions of risk-based monitoring (RBM) in […]
How Sponsors and Patients Benefit From a Site-Centric Partnership
Site-centric partnerships between sponsors and clinical trial sites can significantly enhance patient […]
Successful Regulatory Submission Via the Trifecta of Awesomeness
The article discusses the key elements that lead to a successful regulatory […]
Why the Regional Site Manager Is the Swiss Army Knife of Clinical Trial Monitoring
The Regional Site Manager (RSM) monitoring model enhances clinical trial oversight by […]
Slow the Burn: How to Make Risk-Resilient Vendor Choices
Many pharmaceutical industry experts share similar principles for reducing financial risk when […]
What’s Wrong With My Trial? Uncovering The Root Cause Of Clinical Trial Troubles
Progress can be negatively impacted by clinical trials that hit obstacles. These […]
How to Establish Effective, Scalable Drug Safety Ops Across Multiple Vendors
Effectively managing drug safety operations across multiple vendors is crucial to ensure […]
Second Time’s The Charm — Navigating NDA Submission, Plus A Resubmission Rescue Mission
The article outlines the challenges faced by a biopharmaceutical company during its […]
Rare Disease Clinical Endpoints: Ingenuity Meets Practicality
Discover why the science that brought you to this point can only […]