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SPRI Ukraine
Domestic CRO with
Professional and
Cultural Experience
www.spriukraine.com
Overview
Introduction
SPRI Ukraine Structure
SPRI Ukraine Advantages
Regulatory Affairs
Our Services
Ukraine Facts & Resources
SPRI Ukraine Staff
www.spriukraine.com
SPRI Ukraine
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...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
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SPRI Competitive
Advantages
Our core competencies:
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Fast start-up of Projects: we are local CRO
capitalizing on cultural knowledge and expertise in
the region
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Local Project Manager appointed for no more then 2
Projects
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CRAs available 24/7
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Significant cost savings due to fast and qualified
enrolment and reasonable service fee
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Lots of Patients because of great population
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The majority of patients have never participated in
Clinical Trials and have never been treated
alternatively
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High level of service and responsiveness to all parties
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Highly qualified personnel and staff keeping process
simple
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Ukraine: Country in Eastern Europe
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Tab.1 Population figures for
Eastern Europe (July 2006) 1
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
Our Infrastructure and Services
SPRI
Ukraine
offers an integrated package of
services in clinical trials.
USA
Quartesian
Data Management
Group
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Feasibility
Site Selection
Regulatory Affairs Management
Drug Management
Logistics Management
Project Management
Sites' Management
Clinical Monitoring
Quality Assurance and Quality Control
Organizational Chart
President
Quality Assurance
Department
Clinical
Department
Information Technology
Department
Logistic Department
Business Development
Department
Accounts and Finance
Department
Regulatory Affairs Department
Reporting Lines
President
Vice President
Quality Assurance
Business Development
Chief Accountant
Clinical
Project Manager
Medical Director
Medical Monitor
Lawyer
Regulatory Manager
Secretary
CRA’s
IT Manager
Logistic Manager
Regulatory Affairs
Local
Authorities
Ukraine
State
Pharmacological
Canter
Preparation
and
Preparation
andsubmission
submission of
of regulatory
regulatory
package
obtainingthe
theClinical
Clinical
Trial
package for
for obtaining
Trial
AuthorizationAuthorization
Local Regulatory
Authorities
Obtaining import and export permissions
Central Ethics
Committee
Preparation and submission of study
related documents for ethical expertise
Central and Local
Ethics Committees
Interactions in the course of study
It is usually takes about 60 days to
get the Clinical Trial Authorization in
Ukraine
Customs
House
Customs clearance of
investigational
Custom
House
product and
study supplies
Clinical Trial Application Submission Process
APPLICANT
Application letter and clinical trial materials
State Pharmacological
Centre
Central Ethics
Committee
Primary Review
Specialized Evaluation
Board Sitting: scientific experts
Final Decision
Final Decision
Positive Decision (approval)
Submission for import/export permissions
Applied Clinical Trials, May 2007
2
Negative Decision
Appellation
Our Services
Project
Set-Up
Project Management
Project
Course
Project
Closure
Project resource planning
Feasibility assessment
Budget estimates
Control of compliance
with the client's
requirements
Site selection
Effective management
of the budget
Developing a monitoring
guidelines
Co-monitoring visits
Initial training for
the project team
Contracting with study centers,
Investigators and 3rd parties
Investigator's meeting
Co-ordination of study supplies
custom clearance and shipment
Ongoing communication
with client
Progress meetings in
the course of the study
Regular study status reporting
Grant negotiation
and administration
Reconciliation between the
project team and the
data management group
Co-ordination of study supplies
return and/or destruction
Final project team meeting
Co-ordination site
closure visits
Archiving study materials
Our Services
Study
Initiation
Phase
Study
Monitoring
Phase
Study
Closeout
Phase
Clinical Monitoring
Data collection
for feasibility
Qualification
assessment
of study sites
Regular
update
of the ISF
and TMF
Shipment
of all CRF
pages
Control under
IP/study
supplies
handling,
storage and
accountability
at study sites
Maintaining of
of timely
queries
answering
Document
collection
for submission
to regulatory
bodies and
Ethics
committees
Initiation
of study
sites/
training of
study team
Investigator’s
Site File (ISF)
and Trial Master
File (TMF)
set-up according
to SOPs
Monitoring
visits
included
source data
verification
Monitoring
reports
Maintaining
of timely
SAE reporting
Shipment of
biological
specimens
or their
destruction
Organization of
study supplies/
IP return or
destruction
Archiving of
study
documentation
at the sites
Initial study
supplies/
investigational
product (IP)
provision
Follow-up
activities/regular
communication
with study sites/
control under
patient’s
recruitment
Closure-out
visits
Our Services
Investigators
The investigators are medical doctors.
They are highly qualified - many speak English fluently,
attend international conferences. Clinicians are usually GCP experienced.
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.
Over 60% of clinical investigators have PhD credentials
Our Experience
SPRI Ukraine has the combined experience in the different therapeutic areas
Phases I-III
Cardiology
Oncology
Dermatology
Metabolic Disease
Ophthalmology
Psychiatry
Feasibility Resources in Ukraine
Scientific institutes
Quantity
Institutions of Academy of Medical Science
37
Institutions of Ministry of Public Health
21
Educational institutes and Medical Establishments
Higher Medical Educational Institutes
Physicians (per 100 000)
19
301.60
Doctors and Medical Service Personnel
Medical Establishments and Hospitals
Beds (per 100 000)
718 000
10 800
952.0
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Ukraine Facts
Population 46 000 000 people
Newly Registered
2007, thsd
2006
thsd
total
32807
32240
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.
Ukraine Statistics Committee 4
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© SSC of Ukraine, 1998-2008
Date of the Last modifications: 27/06/2008
Multinational Multicentered Clinical
Trials in Ukraine
160
140
120
100
80
60
40
Pharmacological Center of Ukraine
3
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2006
2005
2004
2003
2002
2001
2000
1998
0
1996
20
Quantity of Approved Clinical Sites Performing
Multinational Clinical Trials in Ukraine
400
350
300
250
200
Pharmacological Center of Ukraine
3
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2007
2006
2005
2003
2001
1998
1997
50
0
1996
150
100
SPRI 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)
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SPRI
UKRAINE
Contact Us
Main office:
15 Kuibysheva street
Kharkiv, 61050, Ukraine
Tel: +38 057 758 11 65
Fax: +38 057 759 02 41
www.spriukraine.com
e-mail: [email protected]
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Recommendations upon request
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References
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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
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