OVER 20 YEARS SAFE AND COMPLIANT TRACK RECORD IN PROJECT DELIVERY
Our experience and expertise allows us to offer a cost effective and flexible service. We provide a tailored service, adapting to the Sponsor’s requirements and priorities in the context of established regulatory, medical and scientific frameworks. We also provide the clinical pharmacology, scientific and clinical expertise required for a functional and successful delivery of study objectives and research questions.
We have vast experience in:
- First in Human/Safety Reviews
- Dose escalation – single, multiple and combined
- Clinical pharmacology (drug-drug interactions, food effect, etc.)
- Biomarker/Pharmacodynamic models
- Cardiology, tQTc
- Bioequivalence/absolute bioavailability
- Customised designs/research projects
Our units are led by a Principal Investigator with over 15 years experience and expertise in early phase clinical services working closely with highly experienced project management, medical investigators and clinical teams.
Our facilities have been successfully audited by the US FDA, Health Canada Inspectorate, Brazil ANVISA, France ANSM, UK MHRA, Austria AGES regulatory authorities, and Thailand Ministry of Public Health.
Risk analysis, evaluation and management of trial participants, and regulatory and sponsor projects are central to the way we work and deliver.