We spotlight major developments in clinical research, from new FDA biopsy guidance and the EU’s CTIS transition deadline.
Dose Optimization in Oncology: Advancing Clinical Trial Quality
The FDA’s latest guidance on dose optimization marks a pivotal shift in oncology drug development.
The Quality Issue – September 2024
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The FDA’s latest draft guidance could reshape clinical research by embedding RCTs into everyday healthcare.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.