SERVICES

Regulatory & Study Startup

We provide comprehensive regulatory and study startup support for early-phase clinical trials. Our services include protocol development, regulatory submissions, ethics committee coordination, and site initiation. Close collaboration with sponsors ensures smooth timelines and regulatory compliance across jurisdictions. Our experienced team minimizes startup risk and enables rapid activation of clinical studies.
  • 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
  • 24/7 safety monitoring and emergency readiness
  • Qualified investigators and trained study teams
  • Confidential handling of participant data
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20+ Years

Experience in early-phase clinical research

Phase I Unit

Up to 40 inpatient participants

EU Based

Slovenia, European Union regulatory environment

GCP Compliant

Conduct under international quality standards