Understanding the basics of a US FDA BIMO Inspection (includes useful links). The US Food and Drug Administration (“FDA”, or “The Agency”) is empowered to protect public… Read more “US FDA GCP Inspections”
Rethinking GCP Documents: No More SOPs? (a lighthearted perspective)
GCP SOPs are a dry old subject at the best of times. In this article I take a lighthearted look at one new approach we may adopt to get better engagement for anyone conducting clinical research.