Latest News

Our last blog post looked at what is required for a clinical trial unit to achieve an MHRA accreditation, including a commitment to the highest safety standards, comprehensive procedures and processes, and capable, experienced teams. The benefits of an MHRA Phase I accredited site, inspected and approved by regulators, remain the same for a patient […]

During a half day seminar in central London, our scientific colleagues heard from members of our independent Drug Development Advisory Board on a range of topics, including how Project Optimus will affect clinical development plans and considerations for statistical design. You can catch up with some of the presentations on our webinar page.

In our latest blog, we discuss the consideration when placing your phase I study in the UK. You may have come across CROs or Phase I Units with an MHRA Phase I accreditation – but what does this mean? The MHRA’s voluntary phase I accreditation scheme is available to organisations conducting phase I trials but […]

Our MHRA Phase I Accreditation and GCP inspection in May 2024 resulted in no critical or major findings, demonstrating that Simbec-Orion continues to be the leading, fully-comprehensive, clinical pharmacology and laboratory facility within the UK. Well done to everyone on the team! An MHRA phase I accreditation demands the highest quality clinical trials, delivered by experienced […]

Simbec-Orion is delighted to share that as part of our ongoing strategy to provide full support and services to our clients, we have established an entity in the Netherlands through which we are able to import IMP into the EU, QP certify, and then release for use within clinical trial sites across the EU/EEA. This […]

PRESS RELEASE: 26 October 2023 Simbec-Orion, a full-service mid-size CRO, and biotx.ai, a developer of AI-enabled causal modelling for drug development, have announced their strategic partnership to bring AI-powered insights and predictive models to support data-driven clinical trial design. Simbec-Orion, a specialist in oncology, rare disease, and clinical pharmacology studies, has over 45 years’ experience […]

Simbec-Orion is honoured to have been trusted by Oxford Cannabinoid Technologies to run this milestone first-in-human Phase1 clinical trial of its lead compound, OCT461201 for Postherpetic Neuralgia (PHN) & Irritable Bowel Syndrome. Chief Scientific Officer, Valentino Parravicini recently discussed the significance of partnering with Simbec-Orion for the first-in-human Phase 1 clinical trial of the lead compound, […]