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

This two-part webinar series discusses the transition from nonclinical to early clinical from a regulatory perspective and highlighting the key areas where your program can benefit from some forward thinking and planning for your next steps.

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 people working at Simbec Orion are dedicated, very professional and they cover all aspects of clinical research. A team will be set up for your project, who will have a strong focus on your study in a very open minded and friendly atmosphere. The studies I have outsourced to Simbec Orion, have been successfully managed and performed. I will use Simbec Orion in the future and I can strongly recommend them to other pharmaceutical companies.

Tina Lidén Mascher, Head of Clinical Operations

Klaria AB

Got a question?
Get in Touch or Submit an RFI/RFP

Our team is on hand to answer any questions you might have relating to the work we do at Simbec-Orion. Just fill in the form below, making sure to tick the boxes that apply, and we’ll respond as quickly as we can.

Looking to volunteer for a clinical trial?

Visit our dedicated volunteer website here, or email [email protected]

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