Solutions OP Clinical Trials UK

In this episode we discuss with Lydia Ainsworth, our Senior Clinical Data Quality Manager, what we learnt from the Institute of Clinical Research (ICR) Conference, 13-14 Apr 2026.

The conference covered the latest clinical trials regulatory changes which affect the pharma and biotech industry. There were representatives from UK regulators MHRA and HRA, but also from the industry, academia and NHS.

You can learn about the clinical trials regulations changes; what is coming in the medical devices' field; the importance of patient engagement; the use of AI in clinical research; latest trends in drug development and...

This is a short overview of the current development of cell and gene therapies and their challenges. It discusses the different types of cell therapies; latest developments and the challenges of creating allogenic cell therapies.

Terminology is avoided on purpose to present the information in accessible way for those without scientific background.

In this episode we decided to use a new approach in regulatory affairs and tell people how to fail their BLA (Biologics License Application) and piss off their FDA reviewers at the same time. In order to do that, Arvilla Trag, who is a Chemistry, Manufacturing and Controls (CMC) industry expert helped by walking us through the FDA CMC Hell where we met all kind of people from pharma companies and heard all kind of interesting ideas on how not to complete the CMC section.

We would like to apologize to anyone who accidently learnt something from...

In this episode we are discussing the clinical research opportunities in Japan. Our guest is Tetsu Yung who is a consultant with extensive experience in pharma and CRO industry in Japan. We cover the main requirements for setting up clinical trials in Japan and the timelines for obtaining approvals. We also talk about initiatives from the Japanese government to encourage pharma start-ups to set up in Japan and conduct their clinical research in the country.

You can find the script for the interview here: https://solutionsop.co.uk/2026/04/10/clinical-research-opportunities-in-japan-interview-with-tetsu-yung/

In this episode we are talking with our Senior Clinical Data Quality Manager, Lydia Ainsworth, about animal testing in clinical research.

Join us to learn:

You can find transcript on our discussion here: https://solutionsop.co.uk/2026/03/25/do-we-need-animal-testing-overview-with-lydia-ainsworth/

This episode is an analysis of the latest investment trends in research and development in the pharma industry in 2026. You can learn what has changed in clinical research and the way companies invest in developing new drug products. It touches on investment risks, price pressure and the threat from biosimilars.

In this episode of the podcast, we discuss with Richard Vincins, medical device expert from MD Compliance, the medical device registration process in Europe and the challenges that the small and mid size manufacturers face. We also discuss what could be done to help medical device manufacturers to improve market access and innovations in Europe.

You can find the transcript of this episode here: https://solutionsop.co.uk/2026/03/02/medical-devices-registration-in-europe-interview-with-richard-vincins/

In this episode we talk about clinical trials in primary care and the role of general practitioners (GPs) and family doctors in clinical research with the Dr Daphne Hazell who is a GP and CEO of the biggest GP network in the UK which is involved in clinical research. We discuss the challenges and the benefits of using primary care in clinical research.

You can read our transcript to the interview here: https://solutionsop.co.uk/2026/02/09/the-role-of-family-doctors-in-clinical-research-interview-with-daphne-hazell/

In this episode you can learn about the challenges of conducting clinical trials in Africa but also about some ongoing work which is aiming to create more opportunities for clinical research on the continent. In addition, there are some practical recommendations what could help African countries to establish better clinical research facilities and network.

There is a growing call for more wide-spread prostate cancer screening. In this episode you can learn about the methods used for prostate screening and some promising new research in the field. It will also answer the question why the medical bodies are against the roll out of the screening program to more men.

The guest of this episode is Liz Hawes who is a registered nurse specialising in wound care and also CEO of a company providing clinical research services. She provides an overview on the current situation with wound care and the available treatment options. We also discuss what could be done to improve wound healing and attract clinical research in the field. In addition, she gave very powerful examples of the critical importance of wound healing and how it can have a significant impact on patients' lives.

You can read the script here: https://solutionsop.co.uk/2025/12/26/how-important-is-wound-healing-interview-with-liz-hawes/<...

This episode is analysis of the effect of Assisted Dying Bill in the UK on clinical research. It examines why it patients with advanced diseases are critical for developing new drugs. It also explores if we should offer patients option to participate in clinical research instead of assisted dying.

Why should we offer patients opportunity to participate in clinical research instead of assisted dying option? You can find out in this episode.

This episode is a quick recap of the Regulatory Intelligence Conference which happened on 3rd and 4th of Nov 2025 in London. The event was organised by TOPRA and RAPS. It also contains analysis on how startups companies are affected by lack of regulatory intelligence resources and what could be done to help startup companies to improve their access to regulatory intelligence.

In this episode of the podcast we are discussing patients engagement in clinical trial with Keith Berelowitz, who is the chair of Fulham Ethics Committee and entrepreneur working on a new AI powered platform aiming to improve recruitment in clinical trials. Apart from discussing how their platform pRxEngage operates we are also talking about the main challenges in recruiting patients in clinical trials and what could be done to improve reach out to different communities.

You can read the transcript of our interview here: https://solutionsop.co.uk/2025/11/14/how-to-engage-more-patients-in-clinical-trials-interview-with-keith-berelowitz/

In this episode we are talking to Steven Edmunds, who is advanced nurse practitioner at Royal Marsden Hospital in London, UK. The focus of our discussion is the role of the nurse practitioners in clinical research but also as a career opportunity for experienced and knowledgeable research nurses looking to take on more responsibilities.

You will be able to read the transcript of our discussion here: https://solutionsop.co.uk/2025/10/31/the-role-of-nurse-practitioners-in-clinical-research-interview-with-steven-edmunds/

This episode covers the latest developments in the UK life science sector where some big pharma companies are pausing investment or cancelling their investment projects. The analysis touches on the international situation and country specific problems which led to these consequences.

This episode is an overview of the FDA Chemistry Manufacturing Controls Pilot Program and lessons learnt from the current participants in the pilot. It covers what is the scope of the pilot program and some of the unique challenges in manufacturing. Would that pilot be useful for small pharma companies and startups?

You can read our transcript here: https://solutionsop.co.uk/2025/10/09/is-the-fda-chemistry-manufacturing-controls-pilot-program-helpful-for-pharma-startups/

In this episode we are discussing the current challenges in the clinical research job market with the experienced recruiter, Harry Henson. He shares with us his advices for young job seekers who are looking to find their first job in clinical research after graduating school or university.

Transcript of this interview is available here: https://solutionsop.co.uk/2025/10/01/finding-your-first-job-in-clinical-research-discussion-with-harry-henson/

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...

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...

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.

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.

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.

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.

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.

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.

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.