Sponsor oversight has always been a fundamental component of ICH-GCP. It was already reinforced in E6 (R2) with the introduction of Risk-Based Quality Management (RBQM). Oversight responsibilities were clearly addressed in earlier versions of the guideline, notably in relation to CRO oversight, trial management, data handling and record keeping, as well as investigator selection and supervision. With the release of ICH-GCP E6 (R3), sponsor oversight is further clarified and s

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...

On the 30th of November, we celebrated the 20th anniversary of the KCE (Centre of Expertise in Health Care). It was a very enlightening...

What a difficult question? After all, quality has been mainly the responsibility of quality managers, and now project managers should...

During the last holidays I was thinking about what we do every day in clinical trials and how bureaucratic we are. ICH-GCP R3 clearly...

Even though it is still a draft, it is good to be prepared for this new version of Good Clinical Practice. This is not just an addendum...

Hi everybody, in this blog I will try to share regularly what I learned and still experienced every day when working in Clinical trials...