by digitalrefresh | May 24, 2023 | Blog
As the revised guideline of 𝐈𝐂𝐇 𝐄𝟔(𝐑𝟑) 𝐆𝐨𝐨𝐝 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞 (GCP) has been endorsed by ICH Expert Working Group (EWG) on 19th May 2023 and the draft document now published, there is a lot of talk about how the principles have changed. Initially, we were told there...
by digitalrefresh | May 19, 2023 | Blog
Introduction: Good Clinical Practice (GCP) guidelines play a vital role in ensuring the ethical conduct and quality of clinical trials. The original efficacy guidelines were published in 1997 and the R2 update occurred in 2016. Over time, as the landscape of clinical...
by digitalrefresh | Oct 27, 2021 | Blog
So, four years after it entered into force, the Medical Devices Regulation (MDR) is now here. It became applicable on the 26 May 2021. The implementation has been slow, and it has been very frustrating for all those working in the Medical Device Industry, not knowing...
by digitalrefresh | Aug 27, 2021 | Blog
Working within a laboratory in a Clinical Trial environment is a complex role. One small action can have major impacts on the outcome of an experiment. This blog explores some of the most common ways in which errors to GLP guidance occur. 1. Not evaluating the results...
by digitalrefresh | Apr 3, 2021 | Blog
At some point, we’ve probably all seen the spectacular sight of geese flying together in a V. Why do they do this and what can we learn about leadership from it? Each bird flies slightly above the bird in front of them, reducing wind resistance. The geese take turns...
