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 research organisation. Simbec-Orion has more than four 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.

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.



A responsive CRO

With over 450 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 (view 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) (view 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. For example, this 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.

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.

Phase I Units

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.

Let’s collaborate

If you think we could be right for you, get in touch.

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