Phase I-IV Clinical Trials

  • Over 150 Phase I to Phase III studies completed
  • 35-40 new studies initiated/year
  • More than 1500 subjects randomized in the last 3 years
  • Up to now 2 regulatory inspections by FDA in 2018 and 3 inspections by Hungarian Regulatory Authority in 2009, 2015, 2018
  • Over 30 sponsor and CRO audits successfully completed
  • Worldwide top enroller in 20% of the studies in many different indications
  • Patient retention is over 95%
  • Contracted recruitment targets reached over 95% of the cases
  • Therapeutic areas: healthy volunteers, pulmonology, onco-pulmonology, cardiology, diabetology, lipidology, rheumatology, gastroenterology, infectology, gynecology, dermatology, neurology, psychiatry
  • Investigator Initiated Trials (IITs)
  • Local radiology (DXA, X-ray, CT, MRI) and laboratory (safety lab., serology, molecular biology) services
  • Full time dedicated, well experienced and trained Clinical Research Staff (Investigators, Trial Pharmacists, Project and site managers, Study coordinators, Study nurses, Medical assistants)

 

Early Development Trials

  • Phase I-II Proof-of-Concept [POC]
  • Adaptive design studies: healthy volunteer and patient
  • First in Human [FIH]
  • Single Ascending Dose [SAD]
  • Multiple Ascending Dose [MAD]
  • Bioavailabilty/Bioequivalence [BA/BE]
  • Pharmacokinetics/Pharmacodynamics [PK/PD]
  • Dose ranging and Tolerability studies
  • Food Effect studies
  • Drug-Drug interaction studies