We provide the following services:
  • Evaluation of the appropriate and best qualified centres in Romania
  • Preparation of the participating centers for each clinical trial
    • Recruitment of patients according to the study clinical trial protocol
    • Guarantee the quality according to international and Romanian rules
    • Internationally acknowledged laboratories
  • Contractual negotiations
  • Drafting of the investigators' reports
  • Preparation and editing of the Case Report Forms(CRFs)
  • Arrangement and scheduling investigators' meetings
    • Clinical Trial Project management
    • Initiation, current and closed monitoring of the centres by medically trained and highly qualified, bilingual or multilingual monitors
    • Management of the clinical research sites
  • Drafting the medical reports
  • All administrative and back-office work (vote of the ethic commission, authorities approvals, customs regulation) according to international and Romanian Law.
  • Biostatistics
  • Bioavailability / Bioequivalence
  • Human Pharmacology
  • Pharmacodynamics / Pharmacokinetics
  • Pharmacovigilance
    • Phase I / Volunteer Studies
    • Phase II Studies
    • Phase III Studies
    • Phase IV Studies