This month’s Quality Issue highlights FDA guidance on RCTs and decentralized trials, and invites you to RBQM Ops 2024.
Inside the FDA’s Radical New Plan
The FDA’s latest draft guidance could reshape clinical research by embedding RCTs into everyday healthcare.
New FDA Guidance Reshapes Decentralized Trial Oversight
The FDA’s new guidance on marks a pivotal shift in clinical research, promoting accessibility while emphasizing the need for enhanced risk oversight.
The Quality Issue – July 2024
This month’s newsletter covers the FDA’s updated diversity guidance, hot topics from ACDM, and our upcoming RBQM webinar on building trust between Sponsors and CROs.
The Quality Issue – June 2024
Discover PHUSE’s new white paper on Quality Tolerance Limits and catch up on our RBQM webinar recording.
The Quality Issue – May 2024
In this month’s Quality Issue, we highlight exclusive insights from leading quality management experts.
The Quality Issue – April 2024
In this issue, we unveil new tools to support RBQM implementation, including complimentary access to our premium GCP e-learning course.
The Quality Issue – March 2024
We spotlight global regulatory collaboration and new FDA guidance for early Alzheimer’s trials.
The Quality Issue – February 2024
In this edition, we honor Dr. Janet Woodcock’s transformative impact on drug safety and clinical research.
The Quality Issue – January 2024
In this edition, we spotlight key RBQM events, exciting updates to our OPRA platform, and new resources like the ICH E6 risk management infographic.