Clinic
Over 35 Years Safe and Compliant Track Record in Phase I 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 (including High Risk IMPs-Investigational Medicinal Products)/Safety Reviews
- Dose escalation – single, multiple and combined
- Clinical pharmacology (drug-drug interactions, food effect, etc.)
- Radiolabelled
- Scintigraphy (lung deposition, GI studies)
- Long-stay
- PK/PD
- Biomarker/Pharmacodynamic models (including experimental pain models)
- Cardiology, tQTc
- Bioequivalence/absolute bioavailability
- Dermatology (including skin biopsy)
- Ophthalmology
- Medical devices
- Customised designs/research projects
Our units are led by a Medical Director/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 European units have been successfully inspected by MHRA-GMP, MHRA-GLP, MHRA-GCP, MHRA-Supplementary Accreditation Phase I, US FDA, UK Clinical Pathology Accreditation and Member of CCRA.
Our Montreal facilities have been successfully audited by the US FDA, Health Canada TPD, Brazil ANVISA, France AFSSAPS, UK MHRA and Austria AGES regulatory authorities.
Risk analysis, evaluation and management of trial participants, and regulatory and sponsor projects are central to the way we work and deliver.
Medical Emergency procedures are established, documented, regularly tested and supported by the appropriate number of personnel, qualifications, training, relevant experience, facilities, drugs, equipment and written agreements for transfer and referral to the specialist Medical Emergency Services.
