Turning Resistance into Readiness: A Compliance Team’s Change Management Journey
Client: A global pharmaceutical company specialising in the development of innovative treatments for neurological and psychiatric conditions, with a multi-decade track record of improving outcomes for patients living with brain diseases. Training format: Tailored classroom training Location: Denmark The Challenge Their compliance team was preparing to roll out a new risk assessment tool across the organisation — a significant transition
Annex 2 Is Final: Moving from Understanding the Guideline to Applying It in Practice
ICH adopted Annex 2 of E6(R3) at Step 4 on 3 June 2026. The CHMP adopted it on 25 June, and it comes into effect on 15 January 2027. With that, the GCP framework is complete: the principles document, Annex 1 for traditional interventional trials, and now Annex 2 for trials that incorporate decentralised elements, pragmatic
Why Clinical Trial Recruitment Fails — and What Actually Works
Participant recruitment is one of the most persistent — and most underestimated — risks to clinical study success. Industry analyses routinely find that a large share of studies miss their original enrolment timelines, and that delays at this stage cascade into every downstream milestone. Yet the cause is rarely the science or the regulation. It is
Strengthening Medical Device Regulatory Readiness at the Trials Accelerator – Institute for Clinical Trials in Galway
Practical ISO 14155 and EU MDR Training for Clinical Investigation Staff To equip clinical and research staff with practical, decision-focused regulatory knowledge, the Trials Accelerator partnered with ECCRT to deliver a one-day, face-to-face training on ISO 14155, EU MDR 2017/745, and ICH-GCP E6(R3). About the Organisation The Trials Accelerator isupports the planning C design of biomedical research, and supports
Global Pharma Company Equips Medical Monitors for Clinical Safety
When on boarding newly appointed Medical Monitors, a leading global plasma-derived therapy company required a structured and practical programme to ensure consistent safety oversight across clinical trials. Through a tailored in-house training in Vienna, ECCRT equipped the team with the competence and confidence to take full medical responsibility for study safety. About the Company Our client is a
Preparing Future Clinical Project Managers for Global Trials
Clinical Project Management Training for the University of Namur To strengthen the practical readiness of master's students in biomedical sciences, the University of Namur partnered with ECCRT to deliver a hands-on, classroom-based introduction to global clinical project management, bridging academic theory with real-world trial operations. About the Organisation The University of Namur is a Belgian public university with a
Clinical trial regulations in 2026: what to look out for and how to prepare
Why regulatory change feels constant in clinical research For many people working in clinical research, regulatory change doesn’t feel like something that happens every few years anymore. It feels continuous. This isn’t because regulators are changing their minds all the time. It’s because the way trials are run has changed. Studies are more global. Teams are more distributed.
External Training vs. Internal Training: Which Delivers Better Results for Clinical Research Teams?
Introduction Training is fundamental to clinical research, yet many organizations still debate whether to build programs internally or rely on external partners. As regulatory expectations rise and operational complexity increases, internal teams often struggle to maintain effective training at scale. This article explores the strengths and limitations of both approaches, and why many organizations are choosing to bring
Boehringer Ingelheim and ECCRT Co-Develop Foundational GCP (R3) eLearning to Support Global Teams
Reaching Global Teams with Adaptive GCP Training at Scale Boehringer Ingelheim sought an innovative, scalable, and regulatorily aligned training solution to prepare its global workforce for the ICH-GCP E6 (R3) release. In collaboration with ECCRT, Boehringer Ingelheim co-developed a foundational eLearning course that not only met regulatory requirements but introduced adaptive design elements for greater learning efficiency.
