Why should you choose an MHRA-accredited clinical unit?
12/06/2024
What is a MHRA Phase I accreditation?If you are considering 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 […]
Is the UK on its way to becoming a first-class choice for commercial clinical research?
29/04/2024
One year after the UK’s biggest overhaul of clinical trial regulation in 20 years, is the UK on its way to becoming a first-class choice for commercial clinical research? Legislative changes to streamline clinical trial approvals were announced by the MHRA in March 2023, promising the biggest overhaul of UK regulation in 20 years to […]
Rare diseases: Your questions answered
04/04/2024
Rare diseases cover a huge range of different, specific diseases and conditions. We’ve pulled together some of the most common questions on rare diseases and orphan drugs to give you a better understanding of this important topic. If you want to read even more information, try our comprehensive blog: rare diseases: everything you need to […]
The Importance of Healthy Volunteers in Clinical Trials
04/04/2024
Clinical trials play a pivotal role in advancing medical research and developing new treatments. At the heart of these trials are healthy volunteers, individuals who willingly participate in clinical research to drive medical advancements. In this article, we explore the significance of healthy volunteers in clinical trials and their impact on drug development. What are […]
Clinical Considerations for First-in-Human Clinical Trials
04/04/2024
First in Human clinical trials play a crucial role in ushering investigational new drugs or interventions into clinical practice. First in Human trials, follow preclinical testing, using in vitro and in vivo experimental models to ensure the safety of participants. The process involves four phases, with drug candidates typically gaining approval after the third phase […]
How can AI improve patient outcomes in clinical trials?
20/02/2024
Welcome back to our blog series where we share some of the highlights and key takeaways from our fireside chat with CEO of Simbec-Orion, Fabrice Chartier, and CEO of biotx.ai, Joern Klinger. Our last blog post covered whether AI can help with achieving orphan drug status, recent trends in clinical trial design, how AI can […]
Can AI help with achieving orphan drug status?
13/02/2024
Welcome back to our blog series where we share some of the highlights and key takeaways from our fireside chat with CEO of Simbec-Orion, Fabrice Chartier, and CEO of biotx.ai, Joern Klinger. Our last blog post covered how AI can demonstrate the potential of the pipeline to investors and how AI could disrupt clinical development […]