Clinical Sites

CRU-GLOBAL clinical sites are fully owned by the CRU-GLOBAL’s national affiliate in each country. All the sites are managed from CRU-GLOBAL Singaporean office since 2018. The current clinical sites are in:

  • Hungary (3 own sites and 5 dedicated partner sites)
  • Germany (1 own site)
  • Ukraine (1 own site)
  • Vietnam (1 own site and 4 dedicated partner sites)

CRU-GLOBAL Hungarian site is contracted partner site of Synexus (currently Accelerated Enrollment Solutions).

Phase I-IV Clinical Trials

  • Over 250 Phase I to Phase III studies completed
  • 35 - 40 new studies initiated per 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 the Hungarian Regulatory Authority in 2009, 2015, 2018
  • Over 35 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, oncopulmonology, cardiology, diabetology, lipidology, rheumatology, gastroenterology, infectology, gynecology, dermatology, neurology, psychiatry
  • Investigator Initiated Trials (IITs)
  • Inhouse radiology (DXA, X-ray, CT, MRI) and laboratory (safety lab, serology, molecular biology) services

Early Development Trials

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

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