Solutions OP Clinical Trials UK

Our latest podcast is dedicated to bioequivalence studies and their specific challenges. We also cover what was discussed in terms of inspection findings, cases studies and expectations by FDA and Health Canada on their recent symposium in June 2026. In addition, Lydia Ainsworth, shares with us her practical experience from site level and monitoring level on common issues with blood sample collect...

This episode is review and analysis on the first day of the 5th FDA, MHRA and Health Canada Symposium in June 2026 which covered GCP, clinical trials and risk management.

Clinical trials GCP inspections are common but the expectations can vary between different inspectors and agencies. In this episode, we are discussing with my colleague Lydia Ainsworth, what we learnt during the GCP inspections that we had in Europe in 2025. We cover some key inspection preparation points for the sponsors but also for the hospitals.

This episode is a follow up on round table discussions during the ICR Conference on 13 and 14th of April 2026 in Birmingham. We discuss the common issues related to setting up clinical trials in the UK and also the challenges with adaptation of electronic site files and digital technologies in clinical research. We also provide some recommendations how the processes can be improved and streamlined...

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....

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...

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 this episode we are talking with our Senior Clinical Data Quality Manager, Lydia Ainsworth, about animal testing in clinical research. Join us to learn: What are the most common animals used in animal testing, The typical cost for using animals in clinical research, The ethical issues around using animals, When animal testing is needed in drug development What are the alternatives of animal tes...

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: ht...

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...

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 e...

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 dyin...

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 t...

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 her...

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-...

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-i...

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 audien...

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 med...

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.