ICH E6(R3) Annex 2 readiness assessment
Annex 2 of ICH E6(R3) covers decentralised elements and pragmatic trials and takes effect in the European Union on 15 January 2027.
Annex 2 of ICH E6(R3) covers decentralised elements and pragmatic trials and takes effect in the European Union on 15 January 2027. Sponsors and academic trial units running remote or hybrid elements will need to show how their data flows meet it.
The assessment is a fixed-scope review of a study's remote data flows against Annex 2 expectations, delivered as a written report with a gap list.
The platform itself is designed for Annex 2 requirements: data collected at home carries provenance, identity assurance, a signal-confidence score and an audit trail, and sits alongside the sponsor's existing EDC.
Price
CHF 4,500
Credited in full against a platform contract signed within six months.
Deliverable
Written report with a gap list.
Scope
One study's remote data flows, reviewed against Annex 2 expectations.
Ready to Modernize Your Clinical Trials?
Talk to us about your next study.
Or contact our team for a personalized walkthrough.