In this episode, we discuss with our Senior Clinical Data Quality Manager, Lydia Ainsworth, our recent publication "Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations"

You can also find our publication translated in Chinese here: Translated version in Chinese

In our discussion we cover why we wrote this review, who the target audience is and how it could help medical devices manufacturers improve their informed consent forms (ICFs). We also talk about some ethical aspects and the checklists that we created as part of our review. It is important to stress that our article is summary of our practical experience and contains a lot of examples that could be very useful when developing (ICFs).

The transcript will be available soon.

In this episode we are speaking with Georgi Kadrev, the CEO of Kelvin Health, about the impact and the future of artificial intelligence (AI) in medical diagnostics. We also discuss some of the challenges that medical diagnostics startups face when trying to bring their products to the market and what could the regulators do to support them. Georgi also provides insights on raising funding for medical diagnostics startups in Europe.

The script for this episode is available here: https://solutionsop.co.uk/2025/09/03/ai-and-the-future-of-medical-diagnostics-conversation-with-georgi-kadrev/

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.