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 ..read more

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 ..read more

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 ..read more

This episode is an analysis of the changing genomic data regulations and some upcoming biosecurity regulations and how they could affect clinical research. It covers the following regions: China, USA, UK and the EU ..read more

This episode is dedicated to the budget and contract process for clinical trials in the UK. The main topic is what is the current process, what works and what doesn't and how we can improve it ..read more

Can a clinical trial fail because of poor protocol design? You can learn the answer in this episode which reviews a real life case of a clinical trial which failed because of its protocol design ..read more

This episode is about patients' involvement in clinical trials and the challenges and benefits for the industry of involving patients in the study design and review of patient facing materials. While it is easy to engage patients in academic and social research, there are some unique challenges for pharma and biotech companies ..read more

This episode is about the Research Ethics Committees in Europe and some of the challenges that they will face in the future. It also covers some of the existing challenges that everyone in the biotech and drug development industry faces when dealing with Ethics Committees. At the end, as always, there will be some recommendations how to improve the current practices and address the challenges ..read more

The extended access scheme allows patients to have early access to drugs which are not approved on the market but have shown potential in clinical trials. In the UK for the last 10 years were treated over 1,200 patients while in the USA just in 2022 were treated 2,417 patients. Why is that difference? You can learn more from this episode and what could be done to improve access to medications to more patients in the UK ..read more

This episode is dedicated to some of the main challenges that small pharma and biotech companies face. While funding is a critical one there are other issues like selecting the right consultants and vendors and optimising your clinical trials protocols in order to reduce your costs. There is a discussion on some options to optimise the cost of clinical trials ..read more