The new ICH E6(R3) GCP guideline, impacting clinical studies starting 23 July 2025, introduces significantly more detailed requirements around the integrity and governance of data assets and trial records, including biospecimens, their derivatives, and all associated clinical and assay data generated during trials.

To help precision medicine teams ensure they meet these new requirements, we have developed this compliance checklist. Using QuartzBio’s Precision Medicine AI Agent Platform, with our solutions for Sample Intelligence and Biomarker Intelligence, can help you implement these checklist items and ensure compliance by July.

Check each completed item, get your score below, and contact us for next steps:

What’s your score? Rate your readiness:

0-5: Still using spreadsheets and emails? It’s not too late – QuartzBio’s technology can make digital transformation easy, accurate and fast.

6-11: You most likely have an ecosystem of point solutions to manage your data assets, but it can be a headache to ensure all these solutions are compliant. Let’s connect your point solutions across the precision medicine value chain for a scalable, platform approach to compliance.

12-16: Congratulations, you have a strong foundation of data integrity and governance! You’re ready to optimize risk-based management, leveraging insights across clinical programs, including from closed studies. Learn how QuartzBio’s platform accelerates your data-to-insights lifecycle by 2X or more.

Get in touch for personalized recommendations and a demo of our Precision Medicine AI Agent Platform: