by Sarah Yates | Oct 13, 2026 | Blog
A recent €7 million fine imposed by the Italian Data Protection Authority has brought the handling of patients’ health data into focus. The case concerned a database containing health information relating to approximately one million patients, used for studies...
by Sarah Yates | Sep 15, 2026 | Blog
If you work with in vitro diagnostic medical devices, you will probably already be familiar with the IVDR. The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 replaced the previous In Vitro Diagnostic Medical Devices Directive (IVDD) and brought...
by Sarah Yates | Jul 29, 2026 | Blog
One of the most frequently searched questions about clinical research training is: “How do I get a certificate in Good Clinical Practice?” The short answer is that you need to enrol on a suitable Good Clinical Practice training course, complete the required learning...
by Sarah Yates | Jun 22, 2026 | Blog
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 know why it matters. The regulations exist to protect trial participants and ensure data integrity. However, the way...
by Sarah Yates | Jun 9, 2026 | Blog
On 3 June 2026, the International Council for Harmonisation (ICH) adopted the final version of ICH E6 (R3) Annex 2, marking another significant milestone in the evolution of Good Clinical Practice (GCP). For many organisations, the release of Annex 2 raises two...
