New ICH E6(R3) guideline

The new ICH E6(R3) guideline marks a major shift in how clinical trials are designed, conducted, and monitored — with a strong focus on quality by design, risk-based approaches, and digital innovation.

At mediri, we’re ready.
As a partner for imaging-based clinical trials, we welcome the updated framework, which emphasizes:

• Data integrity and traceability across digital systems
• Patient-centric trial design, including decentralized elements
• Fit-for-purpose quality management
• Clearer roles for service providers like imaging CROs

Our imaging platforms and AI-supported analysis tools are already aligned with these principles — helping sponsors meet regulatory expectations while improving trial efficiency and data quality.

Whether you’re planning a new study or adapting to E6(R3), we’re here to support your transition.