Risk-Based Quality Management (RBQM) is a systematic approach that emphasizes the identification, assessment, and management of risks throughout the clinical trial process to ensure data integrity and participant safety. The cornerstone of RBQM is a well-constructed protocol, as highlighted by the Clinical Trial Transformation Initiative (CTTI) in 2025. This protocol must articulate a clearly defined research question and establish scientifically robust outcomes, validated by

🔹   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 ph

Annex 4 in the draft ICH-GCP E6 (R3) is about data governance. In fact, the content of this guidance is quite similar to the requirements...

A new year always starts with good resolutions for the coming year. What are yours?Why not learn something new? Mine for 2024 is to...