Everything You Need to Know About the New Medical Device Clinical Investigation Standard  The publication of ISO 14155:2026 introduces significant...
ISO 14155:2026 FAQ
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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...
Reflections From The ICR Conference 2026
We recently had the opportunity to attend the ICR Conference in Birmingham, hosted by the Institute of Clinical Research. It’s always valuable...
ISO 14155:2026 Update: What’s Changed and What It Means for Clinical Investigations
The latest edition of ISO 14155 2026, the international Good Clinical Practice standard for medical device clinical investigations, has been...
Why Updating SOP Wording Alone Is Not Enough for ICH GCP E6(R3) Compliance
As organisations across the clinical research industry prepare for ICH GCP E6(R3), many quality and regulatory teams are asking the same question:...