A global CRO delivering early to late phase clinical trials

Say hello to a responsive, specialist, flexible approach

We are Simbec-Orion, an experienced, full-service Contract Research Organisation (CRO), with offices across the UK, Europe, and the United States. Established for over 45 years, and leveraging deep experience delivering first in human clinical trials, we provide bespoke clinical trial services to our small to mid-sized biotech and pharmaceutical partners across Europe, North America and beyond. Across the organisation our scientific teams leverage both a wide therapeutic experience in clinical pharmacology, such as CNS, respiratory, dermatology, vaccines and anti-infectives, to more specialist expertise in Phase I-IV rare disease and oncology.

Our experience defines our expertise

Responding to the evolving needs of our clients has made us the contract research organisation we are today; offering a full-service clinical development portfolio, but with the size, agility, and structure to respond rapidly when needed. With a global team of experienced management, clinical research and scientific advisory specialists, we deliver precise clinical development solutions with expertise.

From leading First-in-Human phase I capability, including a full range of clinical pharmacology studies, through to phase III studies, central laboratory services, and post-marketing, we are the CRO ready to take on the challenge. Whatever the indication or compound you are passionate about, wherever you are in your clinical development journey, we will partner with your team to support every element of your clinical trial.

We are delighted to share the news of our strategic partnership with biotx.ai, a developer of AI-enabled causal modelling for drug development, to bring AI-powered insights and predictive models to support data-driven clinical trial design. Read the full press release 


A closer look at our expertise

Clinical Pharmacology

We have the expertise and facilities to deliver exceptional clinical services, with a full-service unit dedicated to clinical pharmacology. We perform a range of pharmacology studies, including First-in-Human (FIH), food effect, drug-drug interaction and pharmacokinetic studies, at our dedicated Clinical Pharmacology Unit. Our facility also includes an Investigational Medicinal Product management capability as well as an on-site Bioanalytical and Clinical Pathology Laboratory service, enabling rapid turnaround times and eliminating sample shipment costs.

Established for over 45 years, we boast one of the most experienced Clinical Pharmacology Units in the UK, having successfully delivered over 2,000 Phase I/IIa studies in a wide range of therapeutic indications and routes of administration.

Discover clinical pharmacology

Clinical Development Solutions

Throughout its history, Simbec-Orion has played a pivotal role in accelerating the progress of numerous groundbreaking medical therapies within the US and Europe. We are a specialised global CRO with in-depth experience of the most complex clinical studies in the challenging therapeutic areas of oncology and rare disease. Our expertise also includes trials to support patients with unmet clinical needs in a range of indications in the fields of CNS, respiratory, dermatology and anti-infectives.

Our clients are globally located, and with the leadership and expertise of the Simbec-Orion project teams, we conduct and deliver key clinical studies which support their submissions for FDA, EMA, and MHRA approval.

In working with our established teams across the UK, Europe and the USA you will benefit from our in-depth and extensive industry and scientific experience and a comprehensive service you can trust, delivered with the highest level of quality, agility, and responsive customer service.

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Central Laboratory Services

Designed exclusively for the biotech pharmaceutical industry, Simbec-Orion’s full service solution provides central laboratory analyses for Phase I–III trials conducted at investigators sites across the world.

Our combination of expertise, experience and investment in infrastructure enables us to deliver a rapid, responsible, and reliable service, so you can make critical decisions, fast.

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Therapy areas in detail

The clinical research organisation with wide therapeutic experience, specialising in rare disease and oncology clinical development solutions.

Headquartered in the UK, our established teams across the globe are currently supporting Phase I-IV clinical trials within:

Employees across UK, Europe & USA

Let’s collaborate

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

Submit an RFI/RFP

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

In these exceptional circumstances regulators are accelerating approval to support COVID-19 clinical research. Contact us today to find out more.