We spotlight major developments in clinical research, from new FDA biopsy guidance and the EU’s CTIS transition deadline.
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.
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.