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

www.spriukraine.com

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: info@spri.com.uae-mail: info@spri.com.ua

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