After a long break from posting, I'm pleased to reflect on the dynamic developments of the past two years—both within Solutionelle and in my role as Study Lead at KCE Trials.

🔹 2024: A Year of Growth and Innovation

The year was marked by an increase in training requests, new client collaborations, and the development of fresh content. Together with my colleague Julien Vandenbosch, we designed a specialised training on IMP management and IRT setup—a niche topic that proved successful, thanks to GLC Europe's support.

🔹 ICH-GCP E6 (R3) Emerges

Toward the end of 2024, demand grew for comparative trainings on ICH-GCP E6 (R3) versus (R2), across pharmaceutical companies, CROs, and within KCE Trials. The official release of E6 R3 in early 2025 resulted in a comprehensive update of training materials and the creation of entirely new modules. For someone like me—whose primary focus isn't training—this was a significant undertaking. This was also the first occasion on which I had used AI to assist with content development, a challenging yet rewarding experience for a self-described "old-school" trainer.

🔹 Risk-Based Monitoring: A Resurgence

Interestingly, 2025 saw a notable increase in requests for Risk-Based Monitoring (RBM) training. Although regulatory bodies have advocated for RBM since 2013—with E6 R2 and CTR 536/2014 reinforcing its importance in 2016 and 2017—it seems the E6 R3 update finally prompted broader adoption amongst previously hesitant stakeholders.

🔹 New Challenges Ahead

E6 R3 introduces more rigorous expectations around statistical analysis, recordkeeping, and computer system management. Whilst large pharmaceutical companies and CROs are generally well-equipped to meet these standards, smaller CROs, biotech firms, and academic institutions may face significant hurdles. Fortunately, the principle of risk proportionality offers a pragmatic path forward—provided stakeholders, including QA and CRAs, embrace it with clarity and confidence.

🔹 Looking Forward to 2026

We're already witnessing increased interest in Computer System Validation training, and I anticipate further evolution in how E6 R3 is understood and implemented. The coming year will undoubtedly bring new challenges—and opportunities—for those of us committed to advancing clinical trial excellence through education.