Consolidating decades of professional experience with actual requirements

Clinical Trials

PHASE I-III, PHASE IV, NIS

  • Site selection, country and site feasibility
  • RA/EC submissions, review and regular update of approval and reporting requirements
  • Site monitoring / Site management
  • Site contractual negotiations
  • Site/Investigator payment process
  • Project management
  • Safety management / Pharmacovigilance
  • Clinical Supplies Management (GDP certificate)
  • Data Management & Statistics
Non-Interventional Studies
  • Consultancy in differentiating CT – NIS
  • Document preparation
  • Regulatory submission/notification
  • Monitoring procedures
  • Data Management 
  • Statistical Analysis & Final Report

Downloads

Quality Management Brochure
(pdf, 1.1 MB)

Company Presentation
(pdf, 604 KB)

Competence

ISO Certificate

TÜV Austria

Certificate
Austrian Federal Economic Chamber