Phase III CRO Services

Phase III (sometimes referred to as phase 3) 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.

Simbec-Orion is a full-service CRO that provides phase III clinical trial services. Our phase III services include 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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Fully managed phase III clinical trials

A robust trial design is essential for a successful outcome. We can aid with planning and designing 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 can analyse your data from start to finish.

Our labs are 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 close to the research sites, providing day-to-day management of the phase III trial including set-up, site monitoring and closing down.

They are experienced and equipped to handle unexpected events, mitigating delays to your project. They secure the best possible outcomes while prioritising patient safety.

Rare disease and oncology specialisation

Simbec-Orion has experience in a wide range of therapeutic areas, but specialises in rare disease and oncology. We understand the unique challenges that rare disease and oncology 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 expert in rare disease clinical trials. We have experience recruiting patients for rare disease phase III trials. We have a network of hospitals, health professionals and health clinics not just around the UK, but internationally. This allows us to recruit patients for even very rare diseases.

We can help with designing clinical trials that will not just achieve your research objectives, but also be attractive to patients in order to help with recruiting and retaining patients.

What makes Simbec-Orion’s services different?

Simbec-Orion is a small, but full service CRO. You get the attentiveness, flexibility and care of a small 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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