In this edition, we reflect on two standout events, RBQM Summit and SCOPE 2025.
The Quality Issue – January 2025
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.
TRI Joins Veeva’s Product Partner Program
TRI has joined Veeva’s Product Partner Program, integrating OPRA with Vault EDC to deliver faster, smarter RBQM.
RBQDM Takes Center Stage at SCDM 2024
At SCDM 2024, RB-CDM took center stage, signalling a shift toward more strategic, risk-focused data management.
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The FDA’s latest draft guidance could reshape clinical research by embedding RCTs into everyday healthcare.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.
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.