As the July 2025 implementation date for ICH E6(R3) approaches, a significant evolution in regulatory expectations is becoming clear. Discussions at the recent ACT Workshop confirmed what many quality professionals have anticipated: regulatory authorities are intensifying their focus on IT service provider oversight, and eliminating the current gap of not conducting direct routine inspections of IT vendors supporting clinical trials.

You can find the full paper here  IT Supplier QA Under ICH E6(R3)