Phase III CRO Services

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.