Solutions OP Clinical Trials UK

This episode is dedicated to the benefits of self-managed clinical trials for pharma startups. It discusses some of the complex issues that startups face with fully outsourcing clinical trials to clinical research organisations. It also covers what could companies do instead of fully outsourcing clinical trials and how this could help them in a long run.

This episode discusses the challenges of patients involvement in clinical trials design and documents review. While patients' contribution to clinical research is often important is some cases it could be very limited. On the other hand there is a growing reliance from the regulatory agencies on patients' involvement to review informed consents which brings additional complications.

This episode covers the reasons for red tape in the pharma industry and how to improve the interactions between the pharma industry and the regulators. The answer to the question who is responsible for the increasing red tape in the drug development is not simple but both the regulators and the pharma industry have to admit their contribution.

In this episode you can learn about the unique challenges that startups and small pharma companies face and how the regulators can help new products to reach the market. While many regulatory agencies have members coming from big pharma companies their experience may not be sufficient to understand the drug development issues that small pharma companies have to deal with.

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.

The latest episode is about digital therapeutics and what can we expect from them in the future. There is also a discussion on the latest report from MHRA on mental health digital therapeutics and the feedback from users and specialists.