Meet the Team: Deborah Evans, Clinic Manager
05/12/2024
We were delighted to speak with one of our longest-serving colleagues recently. We asked her what her day-to-day looked like and what she enjoyed most about her work.
IMP importation into the UK: frequently asked questions
20/11/2024
Are you considering conducting a clinical trial in the UK but have concerns about additional complexities of IMP importation? As an authorised importer of Investigational Medicinal Products, Simbec-Orion works with biotech and pharmaceutical clients to conduct clinical research internationally and have an experienced and knowledgeable regulatory team to ensure seamless IMP importation for your clinical […]
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 […]