COMAC MEDICAL has established a 24-bed hospital-based Clinical Pharmacology Unit for Phase I BA/BE Studies. The unit occupies the third floor of University Hospital “St Ivan Rilski” in the centre of Sofia. The internal part of the building was totally renovated by COMAC MEDICAL. The unique location of our Phase I Unit,  the largest one in Southeastern Europe, guarantees  rapid and cost-effective conduct and management of Phase I clinical studies.

  • Area of 700 sq.m
  • 24 hospital beds (including 6 intensive care ones)
  • Dedicated medical team (physician present 24H)
  • 24H Emergency Care team
  • High medical staff/ bed ratio
  • Patient experience
  • Possibility to separate cohorts/ trials
  • Physicians’ offices
  • Sampling room
  • Safety and bioanalytical laboratory
  • Pharmacy
  • Lockers
  • Archiving facility
  • Emergency Care equipment (cardiac monitoring)
  • 24H Ambulance
  • Access control system within the facility
  • Temperature monitoring & recording system for all freezers and refrigerators
  • Laminar Flow Cabinet for aseptic drug preparation
  • Central clock system
  • Patient alarm system
  • Hi-tech camera monitoring system
  • Announcement and audio system
  • High-speed Internet connection
  • Alternative light enhancements
  • UPS for all systems (incl. centrifuges and freezers)
  • Fire-alarm system
  • Ventilation/ Air conditioning

Experience of key staff:

  • Principal investigators have more than 5 years experience in conducting clinical trials.
  • Investigators are doctors with more than 5 years experience and working in CTs for at least 2 years.
  • Nurses work for more than 5 years in nursing and at least 1 to 3 years in clinical trials.
  • Pharmacists have at least 1 year experience in clinical research.
  • Head of Laboratory with MD degree, full Professorship and Specialties in Clinical Laboratory Medicine and Clinical Pharmacology; Clinical Laboratory Medicine National Referee.
  • Laboratory Technologists – chemical engineers, M.Sc., with special training and competence in Development and Validation of Chromatographic Methods with Conventional and MS detection according to EMA and FDA requirements.
  • Laboratory Technicians – B.Sc., with special training and qualification to perform Chromatographic Analysis in compliance with GLP requirements.