Is an MHRA accreditation relevant for patient studies?
24/06/2024
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 […]
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 […]
What are Early Phase Clinical Trials?
04/04/2024
Early phase clinical trials are the first stage of testing a new medical treatment, drug, or device in human subjects. The focus of these trials in clinical development is to determine the safety and tolerability of the treatment, as well as to identify any potential side effects. You might also be interested in learning more […]
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 […]