Phase I / First-in-Human
With our two in-house state-of-the-art clinical research units (www.crst.fi) we provide full-service Phase 1 trial packages, from study design to final reports, with over 30 years of experience.
Our Phase 1 expertise includes clinical pharmacology studies in healthy volunteers and patients. We provide tailored service solutions, adapting to the customer’s requirements and priorities in the context of established regulatory, medical and scientific frameworks. We also provide the scientific, clinical pharmacology and clinical expertise required for successful achievement of study objectives. We have experience in small-molecule New Chemical Entities (NCE), biological drugs and vaccines.
We have experience with the following study types:
- Phase 1 studies
- First-in-Human (Single and Multiple Ascending Doses)
- Food effect studies
- Bioequivalence and comparative bioavailability studies
- Biosimilars
- Drug interaction studies
- Formulation studies (incl. i.v., inhaled drugs, transdermal delivery, biologicals, vaccines)
- Pharmacokinetic and pharmacodynamic studies
- Imaging studies (PET, fMRI)
Contact us for consultation on study design approaches, selecting the right clinical setting, and establishing clinical study protocols for Phase I studies.