Florence Healthcare

Spain authorised 962 clinical trials in 2025. Approval is getting faster. Is your centre's documentation keeping pace with the questions monitors and inspectors ask next?

Under ICH E6(R3), sponsors stay accountable for oversight even when the work happens at your centre, so they pass those questions down to you. Centres that can show oversight on request are easier for sponsors to work with. The guide shows how to document it without rebuilding it by hand before every visit.

Fewer findings at monitoring visits means less rework for your team and a stronger track record with sponsors. At a US cancer centre, missing training attestations fell from 14 to 2 per visit after document workflows were connected. The guide shows how, and what ICH E6(R3) now expects of centres.

Since March 2026, the ANSM fast-track has cut authorisation from 31 to 14 days for dossiers that raise no questions. Faster authorisation makes France more competitive for sponsors and moves the pressure onto centres: documents, training and delegation logs have to be ready before the first monitoring visit. Centres that keep pace are the ones ready for the next study.

Monitors from every sponsor ask for the same documents before each visit. With your site file online, your centre decides which monitor sees which study, and for how long. They review before they arrive, and visit time goes to the work that matters. See how research centres are moving their site files off paper.

In Spain, GCP inspections are usually notified in advance, but they can also be unannounced. If an inspector asks how a document got from your centre to the sponsor's file, the answer has to exist already. The guide turns ICH E6(R3) into four questions your team can test itself on.