Readiness Assessment | Where Are You on Your ICH E6 R3 Journey?

The International Council for Harmonization (ICH)'s E6 R3 updates has been likened by some as the “thinking person’s guidance.” With the consultation period ending imminently, time is of the essence to define and adapt to new ways of working under the regulation shifts.

What's Changing?

ICH E6 R3 compliance requires teams to reset their thinking about Quality, including:

• Committing to a cultural mind-shift to put Quality first by identifying factors that are critical to the Quality of a study upfront?
• Implementing technology and innovation to manage the increasingly complex aspects of global studies?
• Developing a risk-proportionate approach?to focusing resources and accelerating studies

How Can You Use ICH E6 R3 Compliance to Drive Business Objectives?

The good news for operational and Quality teams, according to?Janet?Fernihough , PhD, MBA, MCMI, ChMC, Director of Consulting at Syneos Health, is that compliance with ICH E6 R3 can provide a competitive advantage.?

Building on these items sequentially allows teams to not only comply with the shift in regulation but have their compliance game plan positioned to take advantage:

• Quality first?requires a Quality-by-design, not quality-control-based approach. Engage with Quality upfront to define "critical to Quality" factors as a necessary part of study planning, not just a necessary evil when there is a compliance issue. Effective study management processes are essential, and many companies are moving away from “read and understand” to more AI/technology-enabled methods to train on these.
• Robust data integrity has always been a key element of Good Clinical Practice (GCP), but R3 recognizes that not all data points are created equal. Critical data must be prioritized to ensure a validated audit trail from sources that may include wearables, decentralized data, and niche technology providers. Technology providers and some pharma companies are now building AI solutions to better predict risks and issues.
• Flexibility to accelerate studies.?With studies' increasing complexity, R3 requires sponsors to work more agilely: think of “acceptable ranges” rather than “tolerance limits.” Technology will again undoubtedly play a role in defining this flexibility: what may be right for one study to accelerate data collection may be an unnecessary burden to patients and/or diverse stakeholders in a different population.?
• Risk proportionate resource allocation.?If?the previous three capabilities have been built in order, then resources should already be focused where needed most and studies accelerated compared to traditional ways of working. However, maintaining proactive collection and analysis of metrics such as cycle times and repeat deviations will be essential to sustain this effort and a competitive advantage.?

Compliance with ICH E6 R3 impacts every function involved in both study design and management and few companies are ready to embrace this fully. Quality can play a key role as the human in the loop providing not only clear metrics but also critical thinking, creativity and collaboration skills to the rest of the business.

What’s Next?

• Gain a high-level understanding of your level of compliance by completing the brief survey. Readiness Assessment | Where Are You on Your ICH E6 R3 Journey? | Syneos Health
• Perform a gap assessment of your processes against regulatory expectations and identify areas for action, which may be numerous.?
• Engage with experts who understand compliance within the operational complexity of study management and that can bring change management skills to make new ways of working stick and will set you up for success.

How prepared is your team for the upcoming changes? Contact our experts to dive deeper into your regulatory strategy.

Contributors

Janet Fernihough , PhD MBA MCMI ChMC | Director, Consulting

Alex Duncan | Engagement Manager, Consulting

Elloise O’Brien, PhD ?| Engagement Manager, Consulting

Kate Miller | Senior Consultant

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The Syneos Health Insights Hub generates future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment. Driven by dynamic research, our perspectives are informed by our insights-driven product development model and crafted by subject matter experts focused on real answers to customer challenges to help guide decision making and investment.