Head of Clinical Trials Unit
Assistant professor Damir Erceg, MD, PhD
SPECIALIST IN CLINICAL PHARMACOLOGY AND TOXICOLOGY
Study Coordinator/Study Nurse
Marina Jakirović, bacc. med. techn.
- Research professionals with >20 years combined experience in conducting clinical trials.
- Qualified Investigators include Physician-Specialists in pediatrics, clinical pharmacology, toxicology, allergology, pulmonology, ETN and occupational health.
- Access to pediatric populations through CHS Physicians and hospital database, adult populations through CHS collaborative effort with a network of GP/Specialists within the community.
- State-of-the-art facilities/equipment, capacity for multidisciplinary projects and various study designs.
- Quality Standard Operating Procedures (SOP) in compliance with ICH guidances (GCP) and EU/Local Regulations.
- Occupies about 400m2 of the 2nd Floor of the hospital, secure access facility with a patient Waiting Area before the main entrance.
- Large 8-Bed Patient Evaluation Facility (2 groups of 4) equipped for sophisticated vital function measurements and continuous patient safety monitoring.
- Designed to accommodate Phase I to Phase IV study.
- Possibility to perform bioequivalence study (up to 40 volunteers).
- Patient exam rooms, Biomedical Laboratories including equipment for blood sample processing and frozen storage.
- Study Drug Storage Area, equipped to manage both ambient and refrigerated IMP storage requirements.
- Call Centre/Office, Sponsor/CRO Monitoring space.
- Archiving Room, secure-access, temperature-controlled, fireproof.