Simbec-Orion

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? Find out in our latest blog post

An interesting recent announcement regarding the adoption of AI in clinical research from the National Institute of Health, with the development of 'TrialGPT' - aimed at helping match potential volunteers to trials on ClinicalTrials.gov. https://lnkd.in/gShwnKwH

We are proud to be an MHRA-accredited facility, it's our clients' assurance of our high-quality work and focus on patient safety. We have a long-standing and close relationship with both the MHRA and our local REC. We understand the detail of the guidances, and this gives us the confidence to know where we can implement adaptive elements in clinical trials. In this video, our Senior Project Manager Tom Calverley shares more about our experience with adaptive trial design in clinical trials

HIV remains a major global public health issue, having claimed an estimated 42.3 million lives to date. An estimated 39.9 million people were living with HIV at the end of 2023, 65% of whom are in the WHO African Region. In 2023, an estimated 630,000 people died from HIV-related causes and an estimated 1.3 million people acquired HIV (Source WHO, 2024) There is no cure but, thanks to medical science, it has become a chronic but manageable condition. There is still much to be done however to ensure everyone living with HIV AIDS has access to adequate treatment and care.

It doesn’t matter if it’s Healthy Volunteers or patients, without clinical trial participants, you don't have a trial. Our Head of Enrolment Services, Joshua Ursell discusses the importance of considering your study protocol through an enrolment lens in our latest video. Speak with our team about your next study today https://bit.ly/3KDNsv0

Will you be in Munich next week? We are particularly excited to share insights from our new white paper Primed for Optimus: Taking a proactive approach to Project Optimus. Meet Aize Smink and Cristian Ungureanu in Munich to discuss all things #oncology at the 11th Clinical Trials in Oncology Europe meeting on 3-4 December. What questions do you have?

Does your clinical trial require importation of IMP into the UK? As an authorised importer of Investigational Medicinal Products, Simbec-Orion have an experienced and knowledgeable regulatory team to ensure seamless IMP importation for your clinical trial. Find out more in our latest blog post

Complex study designs can save your budget and keep your study milestones on track; incorporating adaptive trial design allows for updates to the study design without the need to go through the process of substantial amendment. That said, they do require experienced and engaged teams who can handle the inherent need for flexibility and adaptability. Tom Calverley, one of our Senior Project Managers, explains more in our latest video.

Ready to take the next step in developing your #oncology therapy, but unsure what that might be? We've got you. Simbec-Orion has been designing and delivering early to late-phase oncology trials for almost 3 decades. Our medical scientists and independent Drug Development Advisory Board are on hand to guide you in your journey to market. Your next step is easier than you think, it's to contact Simbec-Orion. https://bit.ly/3Vmy2RN

A large pharmaceutical sponsor needed to demonstrate that its novel triple combination pMDI formulation could effectively deliver drugs to the lungs of patients with moderate and severe/ very severe COPD. Read our case study to find out how Simbec-Orion and CARDIFF SCINTIGRAPHICS LIMITED ensured complex batch manufacturing was routinely performed and patients were successfully recruited and dosed within timelines.