Solutions OP Clinical Trials UK

This latest episode is an overview of the latest ICH GCP E6 (R3) changes and how they will affect clinical trials. This new guidance was released in Jan 2025 to provide further clarification on risk assessment and new technologies used in clinical research.

Our guest in this episode is the American entrepreneur, Charles Theuer, who has a long career in clinical research and drug development. He shares with us his analysis on the current trends and the future of oncology drug development. In this episode you can learn why there are less cancer clinical trials during the last years and what are the promising therapeutic classes.

Charles has written 2 books which we also discuss in this episode. One of them, Unnecessary Expense, covers important topics in drug development and the importance of self-management of clinical trials which could be of interest for all small companies but also for industry experts.

His books are available on Amazon below:

Unnecessary Expense: An Antidote for the Billion Dollar Drug Problem - https://www.amazon.co.uk/Unnecessary-Expense-Antidote-Billion-Problem-ebook/dp/B09C2JNJ89

Medal Count- https://www.amazon.co.uk/Medal-Count-Fate-Nations-Olympics-ebook/dp/B0F3617YFK?ref_=ast_author_dp

You can read the transcript here: https://solutionsop.co.uk/2025/07/25/latest-trends-and-the-future-of-cancer-research-in-conversation-with-charles-theuer/

Our guest in this episode of the podcast is Tommaso Prosdocimi, the Clinical Operations Manager of Iperboreal Pharma. Iperboreal Pharma is a small company developing new peritoneal dialysis products. We are discussing the necessity of having more treatment options of patients who need dialysis and also the unique challenges that small companies face in developing such products. Our conversation ends with some recommendations for regulators willing to support the development of dialysis products.

You can read the script of our interview: https://solutionsop.co.uk/2025/07/11/the-reality-of-developing-dialysis-products-conversation-with-tommaso-prosdocimi/

Our latest episode is conversation with our Senior Clinical Data Quality Manager, Lydia Ainsworth, in which we discuss clinical research as a career choice and we give advice to graduates who are interested to work in the field. We cover topics like how to gain experience in clinical research, what universities can do to increase awareness in clinical research as career, if you need degree in biology to work in clinical research, some CV creation tips and many others.

You can read the transcript of the interview at our website here.

This episode provides overview of the new clinical trials regulations in the UK which was signed into a law in April 2025. It highlights the main changes of the regulations and provides some background information what triggered these changes.

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.