Solutions OP Clinical Trials UK

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 collection requirements.

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 on dose selection and study design for clinical trials with radiotherapeutics.

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.

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.

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 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.

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.

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.