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www.spriukraine.com
SPRI Ukraine
Domestic CRO with Domestic CRO with Professional and Professional and
Cultural ExperienceCultural Experience
www.spriukraine.com
OverviewOverview
Introduction Introduction SPRI Ukraine StructureSPRI Ukraine StructureSPRI Ukraine AdvantagesSPRI Ukraine AdvantagesRegulatory AffairsRegulatory AffairsOur ServicesOur ServicesUkraine Facts & ResourcesUkraine Facts & ResourcesSPRI Ukraine StaffSPRI Ukraine Staff
www.spriukraine.com
SPRI UkraineSPRI Ukraine
...established in May of 2004 ...was founded by the well-qualified specialists in the
different fields of medicine with vast experience in conducting clinical trials
...specializing in conducting of clinical trials in Ukraine …collaborating with Russian CRO in conducting of clinical
trials in Russia using unified SOPs when partnering ...all the staff are trained according to the principles of
ICH GCP and all the personnel are higly qualified and experienced
www.spriukraine.com
SPRI Competitive SPRI Competitive AdvantagesAdvantages
Our core competencies: Fast start-up of Projects: we are local CRO
capitalizing on cultural knowledgecultural knowledge and expertiseexpertise in the region
Local Project ManagerLocal Project Manager appointed for no more then 2 Projects
CRAs available 24/7CRAs available 24/7 Significant cost savings due to fast and qualified fast and qualified
enrolment and reasonable service feeenrolment and reasonable service fee Lots of PatientsLots of Patients because of great population The majority of patients have never participated in
Clinical Trials and have never been treated alternatively
High level of service and responsivenessHigh level of service and responsiveness to all parties
Highly qualified personnelHighly qualified personnel and staff keeping process simple
Ukraine: Country in Eastern Ukraine: Country in Eastern EuropeEurope
Country Population
Ukraine
(July 2007)
46,490,000
Poland 38,536,869
Romania 22,303,552
Belarus 10,293,011
Czech Republic 10,235,455
Hungary 9,981,334
Bulgaria 7,385,367
Baltic Countries 7,184,974
Slovakia 5,439,448
Croatia 4,494,749
Moldova 4,466,706
Tab.1 Population figures for Tab.1 Population figures for Eastern Europe (July 2006)Eastern Europe (July 2006) 11
www.spriukraine.com
Our Infrastructure and ServicesOur Infrastructure and Services
USA Quartesian
Data ManagementGroup
SPRIUkraineoffers an integrated package of services in clinical trials.
Feasibility Site SelectionRegulatory Affairs ManagementDrug ManagementLogistics ManagementProject ManagementSites' ManagementClinical MonitoringQuality Assurance and Quality Control
Organizational Chart
Quality Assurance Quality Assurance DepartmentDepartment
Quality Assurance Quality Assurance DepartmentDepartment
Information Technology Information Technology DepartmentDepartment
Information Technology Information Technology DepartmentDepartment
Accounts and FinanceAccounts and FinanceDepartmentDepartment
Accounts and FinanceAccounts and FinanceDepartmentDepartment
Business DevelopmentBusiness DevelopmentDepartment Department
Business DevelopmentBusiness DevelopmentDepartment Department
ClinicalClinicalDepartmentDepartment
ClinicalClinicalDepartmentDepartment
Regulatory Affairs DepartmentRegulatory Affairs DepartmentRegulatory Affairs DepartmentRegulatory Affairs Department
PresidentPresidentPresidentPresident
Logistic DepartmentLogistic DepartmentLogistic DepartmentLogistic Department
Reporting Lines
LawyerLawyerLawyerLawyer
Logistic ManagerLogistic ManagerLogistic ManagerLogistic Manager
CRA’sCRA’sCRA’sCRA’s
ClinicalClinicalProject ManagerProject Manager
ClinicalClinicalProject ManagerProject Manager
SecretarySecretarySecretarySecretary
IT ManagerIT ManagerIT ManagerIT Manager
Chief AccountantChief AccountantChief AccountantChief Accountant
Vice PresidentVice PresidentBusiness DevelopmentBusiness DevelopmentVice PresidentVice President
Business DevelopmentBusiness Development
Quality AssuranceQuality AssuranceQuality AssuranceQuality Assurance
PresidentPresidentPresidentPresident
Medical DirectorMedical DirectorMedical DirectorMedical Director
Medical MonitorMedical MonitorMedical MonitorMedical Monitor
Regulatory ManagerRegulatory ManagerRegulatory ManagerRegulatory Manager
Regulatory AffairsRegulatory Affairs
UkraineUkraine
State State Pharmacological Pharmacological CanterCanter
Central Ethics Central Ethics CommitteeCommittee
Local Local AuthoritiesAuthorities
Local Regulatory Local Regulatory AuthoritiesAuthorities
Central and Local Central and Local Ethics CommitteesEthics Committees
Preparation and submission of regulatory package for obtaining the Clinical Trial Authorization
Preparation and submission of regulatory package for obtaining the Clinical Trial
Authorization
Obtaining import and export permissions
Preparation and submission of study related documents for ethical expertise
Interactions in the course of study
Custom House
It is usually takes about 60 days to get the Clinical Trial Authorization in Ukraine
Customs Customs HouseHouse
Customs clearance of investigational product and study supplies
Primary Review
State Pharmacological Centre
State Pharmacological Centre
Clinical Trial Application Submission ProcessClinical Trial Application Submission Process
Applied Clinical Trials, May 2007 2
APPLICANT
Application letter and clinical trial materials
Central Ethics Central Ethics CommitteeCommittee
Central Ethics Central Ethics CommitteeCommittee
Specialized Evaluation
Board Sitting: scientific expertsBoard Sitting: scientific expertsBoard Sitting: scientific expertsBoard Sitting: scientific experts
Final DecisionFinal Decision
Positive Decision (approval) Negative Decision
AppellationSubmission for import/export permissions
Our ServicesOur Services Project ManagementProject Management
Project Project Course Course Project Project
ClosureClosure
ProjectProject Set-Up Set-Up
Project resource planning
Feasibility assessment
Budget estimates
Site selection
Developing a monitoringguidelines
Initial training forthe project team
Contracting with study centers,Investigators and 3rd parties
Investigator's meeting
Co-ordination of study supplies custom clearance and shipment
Control of compliancewith the client's
requirements
Effective managementof the budget
Co-monitoring visits
Ongoing communicationwith client
Progress meetings inthe course of the study
Regular study status reporting
Grant negotiationand administration
Reconciliation between theproject team and the
data management group
Co-ordination of study suppliesreturn and/or destruction
Final project team meeting
Co-ordination siteclosure visits
Archiving study materials
Our ServicesOur Services Clinical MonitoringClinical Monitoring
StudyStudyInitiationInitiation
PhasePhase
StudyStudyMonitoringMonitoring
PhasePhase
StudyStudyCloseoutCloseout
PhasePhase
Data collectionfor feasibilityassessment
Qualification of study sites
Document collectionfor submission to regulatorybodies andEthicscommittees
Initiation of study sites/ training ofstudy team
Investigator’sSite File (ISF)and Trial MasterFile (TMF) set-up according to SOPs
Initial study supplies/investigational product (IP) provision
Regularupdateof the ISF and TMF
Control under IP/study supplies handling, storage and accountability at study sites
Monitoring visits included source dataverification
Monitoring reports
Maintainingof timelySAE reporting
Follow-upactivities/regularcommunicationwith study sites/control underpatient’srecruitment
Shipment of all CRF pages
Maintaining ofof timely queries answering
Shipment ofbiologicalspecimensor their destruction
Organization ofstudy supplies/IP return or destruction
Archiving of study documentation at the sites
Closure-outvisits
Our ServicesOur Services InvestigatorsInvestigatorsInvestigatorsInvestigators
Over 60% of clinical investigators have PhD credentialsOver 60% of clinical investigators have PhD credentials
Motivated investigators: significant motivation of investigators and their teams: doctors in Ukraine are highly interested in being involved
in the development of new therapies and clinical science. They are experienced clinicians willing to work with direct involvement on all
aspects of the study: which include all ratings, interviews, diagnosing, and data entry.
The investigators are medical doctors. The investigators are medical doctors. They are highly qualified - many speak English fluently, They are highly qualified - many speak English fluently,
attend international conferences. Clinicians are usually GCP experienced.attend international conferences. Clinicians are usually GCP experienced.
Our Our ExperienceExperienceSPRISPRI Ukraine Ukraine has the combined experience in the different therapeutic areas has the combined experience in the different therapeutic areas Phases I-IIIPhases I-III
CardiologyCardiology
OncologyOncology
DermatologyDermatology
Metabolic DiseaseMetabolic Disease
OphthalmologyOphthalmology
Psychiatry
www.spriukraine.com
Feasibility ResourcesFeasibility Resources in Ukraine
10 800Medical Establishments and Hospitals Medical Establishments and Hospitals 718 000Doctors and Medical Service PersonnelDoctors and Medical Service Personnel
Quantity
301.60Physicians (per 100 000)Physicians (per 100 000)
952.0Beds (per 100 000)Beds (per 100 000)
19Higher Medical Educational InstitutesHigher Medical Educational Institutes
Educational institutes and Medical Establishments
21Institutions of Ministry of Public Health37Institutions of Academy of Medical
Science
Scientific institutes
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Ukraine FactsUkraine FactsPopulation 46 000 000Population 46 000 000 people
Ukraine Statistics Committee 4
Newly Registered 2007, thsd 2006 thsd
totaltotal 3280732807 3224032240
neo-plasms 407 414
diseases of the nervous system* 752 764
diseases of blood circulation system 2437 2431
diseases of respiratory organs 13946 13308
diseases of skin and hypodermic cellular tissue 1952 1906
disease of bony and muscle systems and connective tissue 1569 1597
diseases of urogenital system 2132 2172
congenital anomalies (defects of development), deformation and chromosome disorders
51 53
traumas, poisoning and some other consequences of external affects
2284 2289
According to IDC-10 diseases of eyes and eye adventive organ and diseases of ears and mammillary appendix were eliminated from class of diseases of the nervous system and hearing and classified in separate groups.
© SSC of Ukraine, 1998-2008Date of the Last modifications: 27/06/2008
www.spriukraine.com
Multinational Multicentered Clinical Multinational Multicentered Clinical Trials in UkraineTrials in Ukraine
0
20
40
60
80
100
120
140
160
1996
1998
2000
2001
2002
2003
2004
2005
2006
Pharmacological Center of Ukraine 3
www.spriukraine.com
Quantity of Approved Clinical Sites Performing Quantity of Approved Clinical Sites Performing Multinational Clinical Trials in UkraineMultinational Clinical Trials in Ukraine
0
50
100
150
200
250
300
350
400
1996
1997
1998
2001
2003
2005
2006
2007
Pharmacological Center of Ukraine 3
www.spriukraine.com
SPRI StaffSPRI Staff Dr. Kupershtock Igor, President, 15 years of
management experience with Pharma and CRO Industries
Blinder Arnold, VP, PhD, 5 years of experience in
clinical trials, project and site management in USA Martynov Arthur, MD, PhD, Medical Director/ Scientific
Adviser Pylypenko Maksym, PhD, MD, Quality Assurance 2 Project Managers (1 MBA, 1 MA) 5 CRAs (4 MD, 1 PhD) Regulatory Manager (MA) Logistic Manager (MA)
www.spriukraine.com
Main office:Main office:15 Kuibysheva street15 Kuibysheva streetKharkiv, 61050, UkraineKharkiv, 61050, UkraineTel: +38 057 758 11 65Tel: +38 057 758 11 65Fax: +38 057 759 02 41Fax: +38 057 759 02 41www.spriukraine.come-mail: [email protected]: [email protected]
Recommendations upon request
SPRISPRI UKRAINEUKRAINE
Contact UsContact Us
www.spriukraine.com
ReferencesReferences
1. World Health Organization www.who.dk 2. Applied Clinical Trials, May 2007 3. Pharmacological Center of Ukraine
www.pharma-center.kiev.ua 4. Ukraine Statistics Committee www.ukrstat.gov.ua 5. Ukraine Oncology Institute www.ucr.gs.com.ua The World Fact Book www.cia.gov