What Are The Regulators Perspectives on Clinical Trials Risk Management?

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/ [https://solutionsop.co.uk/2026/05/15/icr-conference-april-2026-the-latest-on-the-uk-clinical-trials-regulatory-changes/]