A New Era for GCP Compliance

The long-anticipated International Council for Harmonization E6(R3) guideline for Good Clinical Practice (ICH E6[R3]) is officially here, and for sponsors operating in Europe, July 23, 2025, marks the first official enforcement deadline. While the European Medicines Agency (EMA) requires implementation of the guideline much earlier than other regulators, this is not solely a European initiative or a regular update. ICH E6(R3) reflects a global shift in Good Clinical Practice (GCP), and regulators in the United States, United Kingdom, Japan, and other ICH member countries are expected to follow.

For sponsors worldwide, the message is clear: ICH E6(R3) is here, and readiness will soon be non-negotiable.

What’s Changing Under ICH E6(R3)?

Quality by Design and Critical-to-Quality Factors

ICH E6(R3) strengthens the industry’s shift from reactive compliance to proactive planning. Sponsors are expected to embed Quality by Design (QbD) into study protocols, prioritizing patient rights, safety and well-being and the reliability of the trial results data integration from the onset. Identifying Critical-to-Quality (CtQ) factors early, those trial elements that directly affect reliability, helps reduce risk before it manifests. The focus is on designing trials that prioritize what truly matters, not just managing risks reactively.

Enhanced Sponsor Oversight

ICH E6(R3) reaffirms that while trial duties can be delegated, overall accountability cannot. Sponsors must establish clear oversight structures, maintain active involvement throughout the study lifecycle, and document governance with precision. Vendors and contract research organizations (CROs) must be qualified, monitored, and aligned with sponsor expectations, not just at start-up, but continuously.

Support for Decentralized and Patient-Centric Trials

The new guideline encourages flexible study designs that promote patient access without compromising quality. Decentralized clinical trials (DCTs), including tools such as electronic consent (eConsent) and hybrid models, are now recognized under ICH E6(R3) as effective methods to reduce patient burden, support inclusive recruitment, and improve real-time data collection.

Focus on Technology, Data Integrity, and Quality Management Systems

ICH E6(R3) raises the bar for technology enablement. Validated platforms, robust audit trails, and modern Quality Management Systems (QMS) are now expected to support real-time oversight, adaptive responses, and continuous improvement.

What Readiness Really Looks Like

With the EMA’s enforcement deadline nearing, CROs are responding, but at different paces. Some are still updating Standard Operating Procedures (SOPs); others have fully integrated ICH E6(R3) into their operations. For sponsors, evaluating partner readiness goes beyond asking, “Are you compliant?” Instead, ask:

• Have SOPs and QMS frameworks been revised?
• Are role-specific training programs in place globally?
• Are validated technologies (eConsent, electronic patient-reported outcomes [ePRO], remote monitoring) live and operational?
• Is transparent collaboration offered to ensure quality and compliance of the trials?

If you’re feeling behind, you’re not alone. But there’s still time. Even modest adjustments now can strengthen your trial’s quality and inspection readiness.

Want to go deeper? Learn how TFS is uncovering the truths about quality in clinical trials.

How TFS Prepared for ICH E6(R3)

TFS recognized early that the ICH E6(R3) guideline wasn’t just a regulatory update, but a call to evolve. Rather than wait for the final publication, we took a forward-looking approach and began preparing well in advance.

We revised our internal QMS and SOPs to reflect the principles of ICH E6(R3) across departments. Our staff received training tailored by function and geography, enabling them to apply GCP principles from protocol development through site monitoring.

Tools for eConsent, ePRO, and remote source data verification (SDV) are fully operational, supporting decentralized and hybrid trials while ensuring regulatory compliance and participant-centric design.

To support enhanced sponsor oversight, we reorganized our operational model to offer greater transparency and enhanced controls. Through structured governance pathways, collaborative risk assessments, and unified reporting, we ensure sponsors remain actively involved, without introducing unnecessary complexity.

If your CRO team is still adapting, these are the areas to prioritize. And if you need a partner to help accelerate your alignment, we’re here to help. Contact us today.

Why Sponsors Should Act Now

July 23, 2025, is a firm deadline for trials in Europe, and similar timelines are likely to emerge globally. Inspections will reflect the new priorities and ask questions like:

• How was quality integrated into the protocol?
• What systems are in place for ongoing risk-based monitoring?
• How did the CRO validate its technologies and qualify its vendors?
• Were patient experience and decentralization considered in trial design?

Proactive adaptation isn’t just about compliance in theory. It reduces delays, strengthens submissions, and protects against avoidable risks and findings.

Conclusion: Compliance is a Mindset, Not a Checkbox

ICH E6(R3) is more than a regulatory update; it’s a framework for enhancing the overall functionality of the clinical trial ecosystem and improving the way clinical trials are conducted. For sponsors, it’s a chance to embrace smarter design, better oversight, and more resilient studies. At TFS, we’ve welcomed that opportunity, and we’re ready to help you do the same.

Ready to talk about how ICH E6(R3) will impact your next trial?

Let’s connect. Whether you’re seeking an ICH E6(R3)-ready CRO or simply need expert guidance, our team is here to help. Contact our experts today.