A recent €7 million fine imposed by the Italian Data Protection Authority has brought the handling of patients' health data into focus. The case...
GDPR in Clinical Research: 5 Lessons from a €7 Million Fine
read more
Blog
IVDR: What You Need to Know About EU Regulation 2017/746
If you work with in vitro diagnostic medical devices, you will probably already be familiar with the IVDR. The In Vitro Diagnostic Medical Devices...
How do I get a certificate in Good Clinical Practice?
One of the most frequently searched questions about clinical research training is: “How do I get a certificate in Good Clinical Practice?” The short...
ISO 14155:2026 FAQ
Everything You Need to Know About the New Medical Device Clinical Investigation Standard The publication of ISO 14155:2026 introduces significant...
Moving Beyond the Tick-Box: Why We Design Clinical Training Differently
If you have worked in clinical research for any length of time, you have likely developed a love-hate relationship with compliance training. We all...
ICH E6 (R3) Annex 2 Has Arrived: What Does It Mean for Clinical Research Professionals?
On 3 June 2026, the International Council for Harmonisation (ICH) adopted the final version of ICH E6 (R3) Annex 2, marking another significant...