Phase I CRO Services

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Simbec-Orion offers phase I CRO services, also known as phase 1 or early phase from our purpose-built, MHRA Accredited Phase I Clinical Trials Unit in Wales. At this critical point in your drug’s development, you need a responsive and experienced clinical research organisation. Simbec-Orion has years of experience delivering early phase clinical trials. We have all the adaptability and responsiveness of a small CRO, with the resources, international expertise and experience of a much larger organisation.

We prioritise patient safety while delivering on your objectives for the study. We conduct early phase trials with objectives including proof of concept, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD). Our services also include full study design, IMP management and CTA submissions in order to provide you with a fully managed phase I service.

We have a broad range of experience with many therapeutic areas in phase I trials, including our specialty areas of rare diseases and oncology.

A responsive CRO

Simbec-Orion is a full service CRO, offering preclinical and phase I services through to phase III and post market studies. Our clinical trial management services are responsive and built around your needs.

By working closely with you, our project managers drive phase I trials forward, delivering results while prioritising patient safety. We put in place governance and project escalation plans from day 1 to mitigate risk, and have the experience needed to work around any obstacles that might arise.

We have a history of delivering reliable phase I services that align to your trial’s objectives while keeping patients safe.

Our phase I experience

We have worked on a wide range of early phase clinical trials. These include 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. For example, 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 know that as a small to medium sized business, early phase trials can be critical in securing investment for the future development of your product. We’re one of the world’s smallest full service CROs, making us one of the most agile. We can adapt to remove bottlenecks and shorten timelines so you can meet your investors’ expectations.

Phase I is an early stage in 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 build 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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