Why Do We Need Diversity Plans In Clinical Trials?
1.What is a Diversity Plan? In order to know if a new drug or medical device works in specific patient population, we need to have data generated from clinical research….
Continue reading1.What is a Diversity Plan? In order to know if a new drug or medical device works in specific patient population, we need to have data generated from clinical research….
Continue readingOur latest interview is with our Clinical Research Partnerships Manager, Wai Theng Lee, who attended the 20th edition of China Medtec 2024 together with our Regulatory and Study Start Up…
Continue readingThis has been my very first Artificial Intelligence (AI) type of conference that I recently attended. AI is a broader subject and in recent days many new developments have been…
Continue readingMHRA organised a very informative webinar on 5th of Mar 2024 to provide update on the upcoming changes in the UK Medical Devices Regulation (UK MDR). They mentioned several reasons…
Continue readingThere are a lot of pilots that MHRA started back in 2023. This is a short summary of the new initiatives and how they can be helpful for pharma and…
Continue readingThe last year has been very successful for our team. We are grateful that in such challenging times for many businesses, we had the opportunity to set up and manage…
Continue readingFDA have released a final guidance regarding informed consent requirements for clinical trials. This guidance is applicable not only for medicinal products but for medical devices too. In this summery…
Continue readingThere is an ongoing public consultation by the World Health Organization which aims to update its guidelines on clinical trials. There are some really good recommendations in the draft guideline…
Continue readingThere is a growing number of medical device clinical trials globally. While they have lots of similarities in terms of study design and documentations to drug clinical trials, medical device…
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