Solutions OP Clinical Trials UK

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/ [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/ [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" [https://pubmed.ncbi.nlm.nih.gov/40747133/] You can also find our publication translated in Chinese here: Translated version in Chinese [https://solutionsop.co.uk/wp-content/uploads/2025/08/%E4%BC%98%E5%8C%96%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E7%9A%84%E7%9F%A5%E6%83%85%E5%90%8C%E6%84%8F%E4%B9%A6%EF%BC%9A%E5%9B%BD%E9%99%85%E7%9B%91%E7%AE%A1%E6%8C%87%E5%8D%97%E4%B8%8E%E4%BC%A6%E7%90%86%E5%AE%9E%E8%B7%B5.pdf] 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/ [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.