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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 […]

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 […]

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 […]

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 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 […]

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 […]

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 […]