Phase I
We work to sponsor-specific study designs but can also provide detailed scientific input to help to shape a protocol, and provide quick, accurate data analysis, results and reporting. Our clinical and statistical teams have considerable experience in study design and set up for a variety of Phase I studies, including
- multiple dose,
- bioequivalence/bioavailability,
- drug interactions
- PK
- Pharmacodynamic studies in inhalation or GI transit.
We conduct the full range of human pharmacology studies on all types of molecule in all major therapeutic areas including:
- allergy
- anesthaesia/analgesia
- cardiovascular
- dermatology
- respiratory
- GI
- CNS
- infectious disease
- immunology
- inflammation
- obesity
- rheumatology.
We are also experienced in medical devices, cardiac safety testing and vaccines. We have extensive expertise in all key routes of administration but also specialized modes such as inhalation, intravaginal, intraurethral, transdermal (including electrotransport) and intracolonic.
We provide a single project manager for the entire project, ensuring continuity of approach and removing the burden of multi-vendor management from the client. We also offer a full range of support services to our clients, from study set-up through to data analysis and reporting. This can add particular value for international clients who may need the specialist regulatory support we provide when performing their studies in the UK.