1. SPRI Ukraine Domestic CRO with Professional and Cultural Experience

2. Overview Introduction SPRI Ukraine Structure SPRI Ukraine Advantages
Regulatory Affairs
Our Services
Ukraine Facts & Resources
SPRI Ukraine Staff 2

3. SPRI 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

4. SPRI Competitive Advantages
Our core competencies:
Fast start-up of Projects: we are local CRO capitalizing on cultural knowledge and expertise in the region
Local Project Manager appointed for no more then 2 Projects
CRAs available 24/7
Significant cost savings due to fast and qualified enrolment and reasonable service fee
Lots 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 responsiveness to all parties
Highly qualified personnel and staff keeping process simple

5. Ukraine: Country in Eastern Europe
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 Eastern Europe (July 2006) 1 5

6. Our Infrastructure and Services
SPRI
Ukraine
offers an integrated package of services in clinical trials.
Feasibility
Site Selection
Regulatory Affairs Management
Drug Management
Logistics Management
Project Management
Sites' Management
Clinical Monitoring
Quality Assurance and Quality Control
USA
Quartesian
Data Management
Group

7. Information Technology Regulatory Affairs Department
Organizational Chart
President
Business Development
Department
Quality Assurance
Department
Clinical
Department
Accounts and Finance
Department
Information Technology
Department
Regulatory Affairs Department
Logistic Department

8. Reporting Lines President Vice President Quality Assurance
Business Development
Quality Assurance
Medical Director
Chief Accountant
Clinical
Project Manager
Medical Monitor
Regulatory Manager
Lawyer
Secretary
CRA’s
IT Manager
Logistic Manager

9. Regulatory Affairs Ukraine Local Authorities
Preparation and submission of regulatory
package for obtaining the Clinical Trial
Authorization
Preparation and submission of regulatory
package for obtaining the Clinical Trial Authorization
State Pharmacological Canter
Local Regulatory Authorities
Obtaining import and export permissions
Preparation and submission of study
related documents for ethical expertise
Central Ethics Committee
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
product and study supplies
Custom House

10. 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)
Negative Decision
Submission for import/export permissions
Appellation
Applied Clinical Trials, May

11. Our Services Project Management Project Closure Project Set-Up Project
Course
Project resource planning
Feasibility assessment
Budget estimates
Site selection
Developing a monitoring
guidelines
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
Control of compliance
with the client's
requirements
Effective management
of the budget
Co-monitoring visits
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

12. Our Services Clinical Monitoring Study Initiation Phase Study
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
Initial study supplies/
investigational product (IP) provision
Study
Initiation
Phase
Data collection
for feasibility
assessment
Qualification
of study sites
Control under
IP/study
supplies
handling,
storage and
accountability
at study sites
Monitoring
reports
Follow-up
activities/regular
communication
with study sites/
control under
patient’s
recruitment
Monitoring visits included source data
verification
Study
Monitoring
Phase
Regular
update
of the ISF
and TMF
Maintaining
of timely
SAE reporting
Maintaining of
of timely
queries
answering
Shipment of
biological
specimens
or their destruction
Study
Closeout
Phase
Organization of
study supplies/
IP return or
destruction
Archiving of study documentation at the sites
Shipment
of all CRF pages
Closure-out
visits

13. 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

14. Cardiology Oncology Dermatology Metabolic Disease Ophthalmology
Our Experience SPRI Ukraine has the combined experience in the different therapeutic areas Phases I-III
Cardiology
Oncology
Dermatology
Metabolic Disease
Ophthalmology
Psychiatry

15. Feasibility Resources in Ukraine
Quantity
Scientific institutes
Institutions of Academy of Medical Science 37
Institutions of Ministry of Public Health 21
Educational institutes and Medical Establishments
Higher Medical Educational Institutes 19
Physicians (per )‏
301.60
Doctors and Medical Service Personnel
Medical Establishments and Hospitals
10 800
Beds (per )‏
952.0

16. 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
© SSC of Ukraine, Date of the Last modifications: 27/06/2008

17. Multinational Multicentered Clinical Trials in Ukraine
Pharmacological Center of Ukraine 3

18. Quantity of Approved Clinical Sites Performing Multinational Clinical Trials in Ukraine
Pharmacological Center of Ukraine 3

19. 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)‏

20. SPRI UKRAINE Main office: 15 Kuibysheva street Kharkiv, 61050, Ukraine
Contact Us
Main office:
15 Kuibysheva street
Kharkiv, 61050, Ukraine
Tel:
Fax:
Recommendations upon request

21. References 1. World Health Organization www.who.dk
2. Applied Clinical Trials, May 2007
3. Pharmacological Center of Ukraine
4. Ukraine Statistics Committee
5. Ukraine Oncology Institute
The World Fact Book

22. Thank You !