We design and conduct first-in-human studies to assess initial safety, tolerability, and pharmacokinetics of investigational medicinal products. FIH trials are carefully planned with conservative dose selection, sentinel dosing, and stepwise escalation strategies. Our experienced medical team ensures close safety monitoring and rapid response throughout the study. These studies provide the critical foundation for subsequent clinical development while minimizing risk for participants and sponsors.
Ethics Committee approval for all studies
Medical supervision by experienced clinical staff
Clear participant information and informed consent
Conducted in compliance with ICH-GCP and EU regulations
