FDA Guidance on Digital Health Technologies Highlights Risks
New digital health technologies and DCTs bring new types of risks. The FDA guidance sets out what you need to do.
FDA Guidance on Digital Health Technologies Highlights Risks
My RBQM predictions for 2022
A great Sponsor question
It’s all or nothing with ICH E6(R2) Quality Management
Early phase trials need risk-based quality management too
The Quality Continuum
RBQM and Sites: Engage. Don’t beat
Top 3 points from ICH E6(R3)
Should Cost be a Driver for Risk-Based Quality Management?