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Solutions OP Clinical Trials UK

Solutions OP Clinical Trials UK

by Olga Peycheva

Management Medicine

The Ethical Challenges of Clinical Research with Implantable Neural Devices

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 informed consents and investigational plans.

Psychedelics research: Overview of the latest FDA guidance (Jul 2026) and a case study

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, there is an overview of the study design of a clinical trial with psilocybin used in treatment-resistant depression.

Health Canada - What is changing in clinical trials regulations?

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.

Pharmacovigilance: International Overview of Regulatory Opportunities and Challenges

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 agencies, and the use and challenges of AI in pharmacovigilance. In addition, Lydia Ainsworth provides practical perspective of the challenges of collecting drug safety information in clinical trials.

Bioequivalence studies: Inspections and regulators' expectations

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 collections.

What Are The Regulators Perspectives on Clinical Trials Risk Management?

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.

What Did We Learn From European GCP Inspections

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.

How To Improve Clinical Trials Management In The UK: Discussion with Lydia Ainsworth

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.

ICR conference, April 2026: The latest on the UK clinical trials regulatory changes

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 other topics. You can read the transcript of the interview here: https://solutionsop.co.uk/2026/05/15/icr-conference-april-2026-the-latest-on-the-uk-clinical-trials-regulatory-changes/

Are Cell And Gene Therapies The Future Of Personalised Treatments

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.

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