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Solutions OP Clinical Trials UK

Olga Peycheva
FDA
Clinical Trials
Health Canada
Prostate Cancer
Wound Care
Oncology
Regulatory Affairs
Primary Care Research Alliance
Radiopharmaceuticals
MHRA
Canada
CAR T Cell Therapy
United Kingdom
Animal Testing
Good Clinical Practice
Africa
Japan
Assisted Dying
CE Marking
Patient Engagement

This podcast is dedicated to clinical trials and clinical research. We will be discussing different hot topics and analysis of the latest developments in clinical trials in pharmaceutical and medical devices industries. We have interviews with different industry experts.

New episodes will be available every 2 weeks.

PublishesTwice monthlyEpisodes62Founded4 years ago
Number of ListenersCategories
MedicineBusinessHealth & FitnessManagement

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Artwork for Solutions OP Clinical Trials UK

Latest Episodes

In this episode we review why we need women to participate in clinical research with medical devices. We also cover the FDA guidance on sex-specific data collection for medical devices and its main recommendations on the study design and data collect... more

This episode is a review of a white paper from Aug 2026 on dose optimisation for radiotherapeutics. In addition, Lydia Ainsworth reviews the FDA guidance covering the same topic and providing FDA recommendations. The episode contains recommendations ... more

In this episode we review with Lydia Ainsworth an article discussing ethical challenges for clinical research with implantable neural devices. The overview provides valuable insights for ethics committees, researchers and manufacturers designing info... more

This episode is dedicated to psychedelics research. It covers the recommendations from the US FDA guidance from Jul 2026 which clarifies the agency's expectations regarding the drug development and clinical trials design for psychedelics. In addition... more

This episode covers the upcoming changes in the clinical trial regulations in Canada based on information presented by Health Canada. It also contains global trends analysis and comparison to the regulatory changes in the USA and Europe.

This episode is an overview and analysis of the discussions from the 3rd day of the 5th FDA, MHRA and Health Canada Symposium in June 2026. It covers international initiatives for harmonisation of drug safety review among different regulatory agencie... more

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.... more

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.

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Recent Guests

Lydia Ainsworth
Guest with hospital-level experience in clinical trial setup
(mentioned) NHS trusts and hospital site operations
Episode: How To Improve Clinical Trials Management In The UK: Discussion with Lydia Ainsworth
Arvilla Trag
Expert in Chemistry, Manufacturing and Controls (CMC)
Independent/regulatory affairs consultant
Episode: The Guide to The 9 Circles of CMC FDA Hell: Discussion with Arvilla Trag
Tetsu Yung
Guest with broad experience in cellular biology, pharma, and clinical operations in Japan
Tetsunagi Consulting
Episode: Clinical Research Opportunities in Japan: Interview with Tetsu Yung
Richard Vincins
Regulatory Affairs and Quality Assurance Consultant
MD Compliance
Episode: Medical Devices Registration in Europe: Interview With Richard Vincins
Daphne Hazell
Physician and GP by profession; CEO of Primary Care Research Alliance
Primary Care Research Alliance
Episode: The Role Of Family Doctors In Clinical Research: Interview With Daphne Hazell
Liz Hawes
Nurse and wound care specialist; CEO of Clinical Research Solutions; advisory board member of the Primary Care Research Alliance
Clinical Research Solutions; Primary Care Research Alliance
Episode: How Important Is Wound Healing: Interview With Liz Hawes
Keith Berelowitz
Founder of P-REX Engage; chair of Fulham Research Ethics Committee
P-REX Engage; Fulham Research Ethics Committee
Episode: How to engage more patients in clinical trials: Interview With Keith Berelowitz
Steven Edmunds
Advanced nurse practitioner, CIRCOMA team at Royal Marsden Hospital
Royal Marsden Hospital
Episode: The Role Of Nurse Practitioners In Clinical Research: Interview With Steven Edmunds
Harry Henson
Associate Director of RBW Consulting, recruitment expert in life sciences
RBW Consulting
Episode: Finding Your First Job In Clinical Research: Discussion with Harry Henson

Hosts

Olga
Host and Managing Director of Solutions OP, frequently presents regulatory, biopharma, and clinical trial insights.
Lydia Ainsworth
Colleague and co-host, Senior Data Quality Manager with hands-on experience in pharmacovigilance and trial data quality.

Talking Points

Recent interactions between the hosts and their guests.

AI and The Future of Medical Diagnostics: Conversation with Georgi Kadrev
Q: What is your view on funding opportunities in Europe for biotech startups, especially in medical diagnostics?
Funding in Europe varies by trend and priority; pilots and accelerators offer early support, but long times to market, reimbursement challenges, and a relatively conservative VC view persist. There is value in specialized regulatory advisory and staged funding, including grant programs, to bridge from prototype to clinical validation.
AI and The Future of Medical Diagnostics: Conversation with Georgi Kadrev
Q: Tell me a bit more about Kelvin Health and what you are currently doing.
Kelvin Health is a spin-off with a background in visual image recognition, applying thermography and AI to diagnose infection-related conditions and, during COVID-19, exploring thermogram-based detection. The focus is on enabling early, broad screening for vascular issues such as peripheral artery disease to speed up diagnosis and improve patient outcomes.
Latest Trends and The Future of Cancer Research: Conversation with Charles Theuer
Q: What are the main reasons oncology clinical trials have tightened and may remain restrained in the near future?
Budgets have become tighter and returns on capital are under scrutiny; oncology is riskier than other areas, so investors and sponsors are cautious, especially until a validated mechanism reduces risk and demonstrates stronger ROI.
The Role Of Nurse Practitioners In Clinical Research: Interview With Steven Edmunds
Q: How do you become a nurse practitioner and who would qualify for that role?
The role grew out of demand for expanded healthcare coverage and skills; it typically requires advanced practice education, a masters, and qualification to work as a sub-investigator with appropriate delegation and governance in trials.
How To Improve Clinical Trials Management In The UK: Discussion with Lydia Ainsworth
Q: How is digitalisation expected to change trial documentation, and what are the main hurdles?
Digitalisation, especially eTMF, promises easier tracking and reduced paper clutter, but faces hurdles like lack of standardisation across systems and vendors, data protection concerns, and the need for regulator-guided standards to ensure interoperability.

Audience Metrics

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Frequently Asked Questions About Solutions OP Clinical Trials UK

What is Solutions OP Clinical Trials UK about and what kind of topics does it cover?

This show concentrates on clinical trials, regulatory developments, pharmacovigilance, and drug development trends within pharma and medical devices. Across episodes, experts break down complex regulatory guidance, quality management, and trial operations, often featuring practical, real-world insights from site-level professionals. A standout characteristic is the strong emphasis on regulatory strategy, inspections, and data integrity, with seasoned guests sharing hands-on experience to help sponsors, CROs, and study sites navigate compliance and efficiency in clinical research. Listeners are likely professionals seeking actionable guidance for sponsor and site operations, and the podcast often surfaces pragmatic perspectives from people d... more

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1. Huberman Lab

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Solutions OP Clinical Trials UK launched 4 years ago and published 62 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Solutions OP Clinical Trials UK?

Recent guests on Solutions OP Clinical Trials UK include:

1. Lydia Ainsworth
2. Arvilla Trag
3. Tetsu Yung
4. Richard Vincins
5. Daphne Hazell
6. Liz Hawes
7. Keith Berelowitz
8. Steven Edmunds

To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.

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