Solutions OP Clinical Trials UK

This episode has some key advices for pharma and biotech startups which are looking to set up their first clinical trial. It discusses budget, selecting the right vendors, regulatory strategy, protocol design and the risk assessment that startups need to do before they start.

Our analysis on Eisai And Elly Lilly Alzheimer's Clinical Trials scandal. It involves 2 drugs -Leqembi, manufactured by Eisai and Kinsunla, manufactured by Eli Lilly. Both drugs are used to treat Alzheimer’s and they have known side effects of brain bleeding or swelling. It is also known that some patients have genetical predisposition to experience such brain injury. However, some patients died during the Eisai study and many had brain injury adverse events with different severity. There is a discussion on what could have been done to handle the situation better.

This episode of the podcast is providing an overview of METRIC Framework and practical advice on assessing the quality of medical data which is used to train AI. It covers common issues with medical data quality and how these could be tackled.

This episode is dedicated to clinical trials diversity plans. It discusses what are the current regulations in the USA and Europe, why do we need diversity plans and some recommendations how to improve diversity in clinical trials.

Sometimes clinical trials go wrong for various reasons and they need a study rescue. The study rescue requires experienced team who can step in and help bring back the clinical trial to compliance. In this episode you can learn what are the common issues with the clinical trials that end up needing rescue and some practical advices on how to avoid these issues.