Phase I services /

CRU Hungary Ltd. established its first state-of-the-art Phase I Unit in Miskolc within the BAZ County Central Hospital and University Teaching Hospital in 2015. This unit is the largest accredited Phase I Unit in Hungary and currently conduct the 70-80% of all Phase I studies approved in Hungary by regulatory authorities. We conduct inpatient and outpatient Phase I studies in all indications with continuous and high level Intensive care background, as Hungary gets one of the strictest regulation in this field within Europe. Currently 37, full-time employees are working in our Clinical Research Unit in Miskolc (Investigators, Pharmacists, Study Coordinators, Study nurses, Project managers, Medical assistants, General Assistants, Technical Staff) with dozens of external consultants and over 100 referral GPs and Specialists.

The main source of our patients are:

  • Own filterable database with almost 1000 healthy volunteers and over 10,000 patients with detailed medical history
  • Patient pool of our host/background hospital (BAZ County Central Hospital and University Teaching Hospital*, where CRU unit is located), which is one of the biggest hospital in Hungary with a catchment area of 1,2 million inhabitants and as a regional center for oncology, dermatology, infectiology and hematology the territory of these specialities is extended for surrounding counties also
  • Referral Hospitals, GPs and Specialists: we get over 100 contracted healthcare units and healthcare professionals (eg.: Hospitals within our county and neighborhood counties, Outpatient clinics, GP offices)
  • External recruitment tools: advertisements (to be approved by Regulatory according to the local law), external recruiter services
  • *BAZ County Central Hospital and University Teaching Hospital treats over 110,000 patients on 3,472 beds and get 1,25 million ambulatory patient visits in its 167 outpatient units every year.

  • 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