Phase III CRO Services

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Phase III is an exciting phase in your drug’s development. With evidence showing the drug is effective in treating the condition, the final step before approval is evaluating its effectiveness compared to existing treatments. At this critical phase, you need a reliable and experienced CRO.

For almost 3 decades Simbec-Orion teams across Europe and North America have provided comprehensive phase III clinical trial services. Our full portfolio of phase III services includes everything from patient recruitment and trial design, through to integrated trial management, central lab services, biometrics, CRO collaboration, and on-site training.

If you’re looking for an experienced, reliable, and reactive phase III CRO, get in touch with us today.

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You can also meet the team at BIO Europe in Munich, November 6-8, 2023.

Fully managed phase III clinical trials

A robust trial design that delivers your critical endpoints is essential for a successful outcome. Our extensive experience in a broad range of trial scenarios will support the planning and designing of your phase III clinical trial, including risk mitigation, length, protocol writing, and more.

Lab and data management

We don’t just manage and monitor your clinical trial on the ground, but with our fully-integrated central laboratory services we will analyse your data from start to finish.

Our labs are fully equipped for pharmacokinetic analysis (including FIH, Bioequivalence, Bioavailability and Drug-Drug interaction studies using LC/MS/MS). We can also transfer methodologies from other laboratories where required.

A Principal Scientist will be designated to your project, liaising with your clinical, pharmacokinetic, or bioanalytical teams. The same Principal Scientist oversees all aspects of your study from development, validation and study analysis. This allows us to provide you with a consistent and reliable service.

Site management

Each phase III trial has a designated Project Manager. Our Clinical Research Associates (CRAs) are located across the globe and their proximity to the research sites facilitates day-to-day management of the phase III trial including set-up, site monitoring and closing down. Their decentralised team structure ensures that we can provide local support to sites, in their local language and within their local protocols.

All of our teams are experienced and equipped to handle the unexpected events, mitigating delays to your project, and securing the best possible outcomes for your study while prioritising patient safety.

Rare disease and oncology specialisation

Simbec-Orion has experience in a wide range of therapeutic areas, but specialises in oncology and rare disease, including rare oncology. We appreciate the unique challenges that oncology and rare disease phase III trials face, including smaller patient pools, gathering sufficient reliable data, and even funding. Our experience means we can provide effective solutions to the challenges your trial may encounter.

Patient recruitment for rare disease phase III trials

Effective patient recruitment is critical in phase III clinical trials. While earlier stages might require just a handful of participants, phase III can pose new challenges in recruitment and engagement – particularly in cases of rare diseases.

Simbec-Orion is an established expert in rare disease clinical trials. We have experience recruiting patients for rare disease phase III trials. We have a global network of hospitals, health professionals and health clinics across the UK, Europe and the USA that allows us to recruit patients for even ultra rare diseases.

Your trial would be nothing without the patients and Simbec-Orion can support your goals by designing clinical trials that will not just achieve your research objectives, but also be attractive to patients in order to help with recruitment and retention.

What makes Simbec-Orion’s services different?

Simbec-Orion is unique as a full-service CRO. By partnering with us our clients receive the attentiveness, flexibility, and care of a smaller organisation with the integrated service and reliability of a much larger CRO.

We have the experience and resources to deliver on your trial objectives, with attentiveness and flexibility to easily adapt to changes.

Let’s collaborate

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

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