WHITE PAPER | OCT 01, 2025
What is ICH GCP, and How Does It Impact Clinical Planning?
The July 2025 ICH GCP update brings new standards for clinical trials, focusing on flexibility, risk management, and patient engagement.
Key Takeaways:
- Supports digital and decentralized trial designs for greater efficiency
- Requires proactive risk assessment and quality management
- Strengthens data integrity and transparency standards
- Encourages early patient involvement and diversity in trials
- Clarifies stakeholder roles for better collaboration
The new GCP guideline aligns transparency expectations with ethical principles like the Declaration of Helsinki, creating a unified global approach that provides consistency across all markets.
