Phase I
CRO Services
Simbec-Orion offers exceptional phase I CRO services from our purpose-built, MHRA Accredited Phase I Clinical Trials Unit. At this critical point in your drug’s development, you need a responsive and experienced clinical pharmacology team. Simbec-Orion has almost five decades of expertise in the delivery of early-phase clinical trials in both healthy volunteers and patients. We skilfully combine adaptability and responsiveness, with comprehensive capabilities, international reach and deep scientific knowledge to design and conduct early phase trials tailored to your specific regulatory goals.
Innovative & accurate
Phase I
We prioritise participant safety while delivering on your objectives for the study. We conduct a full range of early phase trials including First-in-Human (FIH), food effect, drug-drug interaction and pharmacokinetic studies. Our services also include full study design, IMP management, ethics and CTA submissions in order to provide you with a fully project managed phase I service.
We have a broad range of experience with many therapeutic areas in phase I trials, including CNS, respiratory, dermatology, vaccines and anti-infectives as well as our specialty areas of oncology, rare oncology and rare disease.
Our proven track record in adaptive trial design has benefitted many of of clients. You can learn more about how this approach took one of our biotech clients from Healthy Volunteer to Patient cohort results in 24 months for a rare respiratory condition here.
On-demand webinar
In our latest webinar, Dr Kirsty Wydenbach, Head of Regulatory Strategy, Weatherden and valued member of our independent Drug Development Advisory Board, shares her insights on the benefits of early, proactive engagement with regulators through Regulatory Scientific Advice.
A responsive CRO
With over 460 employees across the UK, Europe and North America, Simbec-Orion is a truly global full-service CRO, offering preclinical and phase I services through to phase III and post-market studies. Our clinical trial management services are highly responsive and sufficiently flexible to be built around your needs.
As leaders in our field, we have a proven track record of delivering reliable phase I services that align with your trial’s objectives. By working closely with you, our experienced project managers will drive phase I trials forward, delivering results while prioritising patient safety.
We will establish governance and project escalation plans from day 1 to mitigate risk. We understand that complex studies continuously evolve and may require a change in scale or flexibility. When your study needs it, you’ll find our teams are both responsive and equipped with the knowledge and experience required to handle any challenges that may arise
Our phase I experience
As a leading clinical pharmacology facility, we have worked on a wide range of early phase clinical trials, including oncology phase I trials such as a multi-centre, non-randomised dose-escalation study for non-hodgkin’s lymphoma and chronic lymphocytic leukaemia (read the case study).
We also have experience in clinical pharmacology for rare diseases including this study investigated the pharmacokinetic properties of a study drug, followed by an expansion cohort treating subjects with idiopathic pulmonary fibrosis (IPF) (read the case study).
As experts in their fields, our clinical researchers and project managers also run webinars and publish research papers on the process of clinical development and stage I studies, driving the industry forward. To learn more, this on-demand webinar discusses how to operationalize your early phase oncology study in a clinical setting to meet business objectives.
A critical early phase
We appreciate and understand that for small to medium-sized organisations, early phase trials can be critical in securing investment for the future development of their product. Our lean management structure means we are a highly flexible team who will adapt to remove bottlenecks and shorten timelines so you can meet your investors’ expectations.
Once you are ready to move on to your next stage of clinical development, we also offer other non-early phase clinical pharmacology services including, drug-drug interaction, food effect and pharmacokinetics studies. Clinical data management, trial design and more, also form part of our fully integrated portfolio.
As a full-service CRO, we are very well equipped to take your study beyond phase I. Our phase II and phase III services mean that, with us, you can take your product from preclinical research to launch.
Phase I &
Clinical Pharmacology
We have a purpose-built clinical pharmacology unit (CPU) equipped for early-phase clinical trials. Our unit is designed to seamlessly move between trial services – from volunteer and patient recruitment to screening, clinical conduct, and on-site laboratories. We also work with hospitals throughout the UK, EU, and beyond.
Decentralised phase I trials
In addition to our purpose-built Clinical Pharmacology Unit, we can also coordinate decentralised phase I trials, where appropriate for the protocol and patient group. This form of clinical trial can remove roadblocks in participation, such as travel times, cost and inconvenience, making patient recruitment smoother.
What our
Clients Say About Us
The Simbec-Orion team have been a brilliant CRO to work with over the last 2 years. You are up there as one of the best units and teams I have collaborated with, you have been open and flexed to accommodate requests when we needed it, and always with a great pragmatic and friendly attitude
Helen Bridger, Biotech Client
