RESEARCH PARTNER IN EASTERN EUROPE
AKUmedRD -Dr Ljahnicky - CRO Croatia
Provides clinical services in the region of Croatia , Slovenia and Bosnia & Herzegovina.
Croatia is a country of 4,4 million people with the largest concentration of the population around Zagreb , the capital city. Due to its western influences, the country has experience and a good track record for conducting clinical trials. The regulatory requirements for registering a clinical trial in
Croatia can take up 60-90 days.
The medical infrastructure as of 2000 is as follows:
General hospitals
Clinical hospitals
Clinical hospital centers
Specialized hospitals
ZAGREB:
KBC( Clinical Hospital Centre ) Zagreb -2000 beds total
KB ( Clinical Hospital ) Dubrava - 750 beds
KB "Sestre Milosrdnice "- 500 beds
KB " Merkur "- 350 beds
General Hospital Sveti Duh - 420 beds
University Hospital for Infectious Diseases- 340 beds
University Hospital for Pulmonary Diseases Jordanovac - 320 beds
University Psychiatric Hospital Vrapθe- 1100 beds
University Clinic for Diabetes and Metabolic Diseases "Vuk Vrhovac "-
200 beds
Childrens University Hospital - 160 beds
Institute for Malignant Tumors - 200 beds
Institiute for Brain - 50 beds
OTHER LARGE CITIES IN CROATIA:
KBC Split - 2034 beds
KBC Rijeka -1822 beds
KB Osijek - 1287 beds
Clinical Trial Services: phase I-IV
Site identification and investigator recruitment
Study management - Prestudy visit
- Initiation visit
- Routine Monitoring visit
- Study sites coordination
- Close-out visit
- Contract negotiations with investigators and hospitals
Coordination of drug import ( drug destruction ) with a specialized registered companies.
Regulatory affairs - preparing submission documents for regulatory approvals(Central Ethics Committy, Ministry of Health )
- Clinical Trial Material Supply -obtaining import license and import of drug
- Annual safety reports to Authorities ,IND letters and CIOMS reporting to Drug Agency
Consultancy in regulatory requirements
Phase I Unit
Phase I unit is located in KBC Zagreb, KBC Rijeka and KBC Split at the Department of Clinical Pharmacology.
Patient fee: 20-80 Euro per day
Hospital expenses per patient per day - 40 euro + lab expenses in pharmacocinetics, ECG, US, Xray...other.
1.-KBC Zagreb- Clinical Pharmacology Department- 2 experienced clinical pharmacologists, several internists , several experienced research nurses, experiemced investigators in many indications
20 beds on disposal, Hospital laboratory experienced in pharmacokinetics in the local hospital and with the Central Laboratory procedure.
2.-KBC Split - Clinical Pharmacology Department
On disposition there are 30 beds, 8 investigators- internists , residents, one professor -who is internist , cardiologist and clinical pharmacologist , very experienced in phase I-II studies and 8 research nurses. Hospital lab. is one of the best equiped in Croatia.
Patient fee is around the same.
MEDICAL DEVICE - first time on humans- 6 studies conducted with indication in barriatric surgery, brain surgery, vascular surgery.
Financial adventage
The economic structure in Croatia introduces lower costs for physicians and medical professionals than in the US or Western Europe. This factor drives investigators grants and CRO fees down by 25-35 %. Combined with rapid patient enrollment , study costs can be significantly reduced without risking performance .
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