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SPRI Ukraine
SPRI Ukraine
Overview
Overview
SPRI Ukraine
SPRI Ukraine
SPRI Competitive Advantages
SPRI Competitive Advantages
Ukraine: Country in Eastern Europe
Ukraine: Country in Eastern Europe
Our Infrastructure and Services
Our Infrastructure and Services
Organizational Chart
Organizational Chart
Reporting Lines
Reporting Lines
Regulatory Affairs
Regulatory Affairs
Clinical Trial Application Submission Process
Clinical Trial Application Submission Process
Our Services
Our Services
Our Services
Our Services
Our Services
Our Services
Our Experience SPRI Ukraine has the combined experience in the
Our Experience SPRI Ukraine has the combined experience in the
Feasibility Resources in Ukraine
Feasibility Resources in Ukraine
Ukraine Facts Population 46 000 000 people
Ukraine Facts Population 46 000 000 people
Multinational Multicentered Clinical Trials in Ukraine
Multinational Multicentered Clinical Trials in Ukraine
Quantity of Approved Clinical Sites Performing Multinational Clinical
Quantity of Approved Clinical Sites Performing Multinational Clinical
SPRI Staff
SPRI Staff
SPRI UKRAINE
SPRI UKRAINE
References
References
Thank You
Thank You

Презентация: «SPRI Ukraine». Автор: Artem. Файл: «SPRI Ukraine.ppt». Размер zip-архива: 412 КБ.

SPRI Ukraine

содержание презентации «SPRI Ukraine.ppt»
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1 SPRI Ukraine

SPRI Ukraine

Domestic CRO with Professional and Cultural Experience

www.spriukraine.com

2 Overview

Overview

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

www.spriukraine.com

3 SPRI Ukraine

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

www.spriukraine.com

4 SPRI Competitive Advantages

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

www.spriukraine.com

5 Ukraine: Country in Eastern Europe

Ukraine: Country in Eastern Europe

Tab.1 Population figures for Eastern Europe (July 2006) 1

6 Our Infrastructure and Services

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

www.spriukraine.com

7 Organizational Chart

Organizational Chart

President

Quality Assurance Department

Business Development Department

Clinical Department

Accounts and Finance Department

Information Technology Department

Regulatory Affairs Department

Logistic Department

8 Reporting Lines

Reporting Lines

President

Vice President Business Development

Quality Assurance

Chief Accountant

Clinical Project Manager

Regulatory Manager

Lawyer

Secretary

CRA’s

IT Manager

Logistic Manager

Medical Director

Medical Monitor

9 Regulatory Affairs

Regulatory Affairs

Ukraine

State Pharmacological Canter

Local Regulatory Authorities

Central and Local Ethics Committees

Central Ethics Committee

Customs House

Custom House

Customs clearance of investigational product and study supplies

It is usually takes about 60 days to get the Clinical Trial Authorization in Ukraine

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

Preparation and submission of regulatory package for obtaining the Clinical Trial Authorization

10 Clinical Trial Application Submission Process

Clinical Trial Application Submission Process

State Pharmacological Centre

Central Ethics Committee

APPLICANT

Board Sitting: scientific experts

Application letter and clinical trial materials

Primary Review

Specialized Evaluation

Final Decision

Final Decision

Positive Decision (approval)

Negative Decision

Submission for import/export permissions

Appellation

Applied Clinical Trials, May 2007 2

11 Our Services

Our Services

Project Management

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

Our Services

Clinical Monitoring

Study Initiation Phase

Study Monitoring Phase

Study Closeout Phase

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

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

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

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

Our Services

Investigators

Over 60% of clinical investigators have PhD credentials

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.

14 Our Experience SPRI Ukraine has the combined experience in the

Our Experience SPRI Ukraine has the combined experience in the

different therapeutic areas Phases I-III

15 Feasibility Resources in Ukraine

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 100 000)?

301.60

Doctors and Medical Service Personnel

718 000

Medical Establishments and Hospitals

10 800

Beds (per 100 000)?

952.0

www.spriukraine.com

16 Ukraine Facts Population 46 000 000 people

Ukraine Facts Population 46 000 000 people

Ukraine Statistics Committee 4

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.

www.spriukraine.com

© SSC of Ukraine, 1998-2008 Date of the Last modifications: 27/06/2008

17 Multinational Multicentered Clinical Trials in Ukraine

Multinational Multicentered Clinical Trials in Ukraine

Pharmacological Center of Ukraine 3

www.spriukraine.com

18 Quantity of Approved Clinical Sites Performing Multinational Clinical

Quantity of Approved Clinical Sites Performing Multinational Clinical

Trials in Ukraine

Pharmacological Center of Ukraine 3

www.spriukraine.com

19 SPRI Staff

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)?

www.spriukraine.com

20 SPRI UKRAINE

SPRI UKRAINE

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: info@spri.com.ua Recommendations upon request

Contact Us

www.spriukraine.com

21 References

References

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

www.spriukraine.com

22 Thank You

Thank You

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