CRU Global gets 3 different sites within Hungary:

 

  • 1 Unit with 2 separate 2 Departments in Miskolc city (Early Phase Unit and Later Phase Unit)
  • 1 Unit in Kisvarda city
  • 1 Unit in Hatvan city

The catchment area of the site in Miskolc (which is located within the one of the biggest Hospital in Hungary) is about 1,2 million inhabitants and the catchment area of the other 2 sites are 6-800,000 inhabitants.

 

 

Phase I-IV Clinical Trials

  • Over 200 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