Headquartered in Ukraine Carpathian Research Group LLC is a privately-owned clinical research organization (CRO) supporting broad range of R&D activities for biopharmaceutical and medical device industry across Ukraine and neighbouring countries (including, but not limited to Georgia, Moldova, Turkey, Romania, Bulgaria, Kazakhstan, Uzbekistan and Belarus).

1. 2018, © CRG LLC, All Rights Reserved.
Carpathian Research Group LLC
February 2019
Company overview

2. 2018, © CRG LLC, All Rights Reserved.
Message from CEO (Director)
Dear collaborators!
Thank you for taking your time to get acquainted with our
company! We at CRG LLC are a true family of passionate
professionals who strongly value our Clients and execute
flexible approach in doing business. We do not want to be
just the one of thousands of organizations in clinical
research, we want to be your solution in clinical trials! We
are always opened to discussion should you have any
inquiries. In the end – it is the health and quality of life for
millions of patients worldwide that matter the most and we
are proud to be the part of the global clinical research
community.
Sincerely yours,
Volodymyr Galyuk, MD, PhD

3. 2018, © CRG LLC, All Rights Reserved.
 Established in February 2018;
 Headquartered in Ukraine;
 Multi-functional Clinical Organization (CRO / SMO / Medical
Devices);
 ISO 9001:2015 and ISO 45001:2018 certified (October
2018);
 Executive team consists of clinical research professionals
with around 15 years of expertise in different fields of the
industry.
 Company has large database of investigators/scientific
advisors in various medical areas;
 Company has large database of freelance clinical research
professionals ready to join the company at any given
moment.
Key facts:

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Area of operations
Ukraine
Belarus
Moldova
Romania
Bulgaria
Turkey
Kazakhstan
Uzbekistan
Total population in all covered countries ~ around 214 million
people

5. 2018, © CRG LLC, All Rights Reserved.
Why we are where we are:
 Countries with favorable environment for doing
business and with continuous progress in
reformation;
 Long history of participation in clinical research
and its support on the state/government level;
 Still high morbidity and big pool of potential
subjects for clinical trials;
 Traditionally high recruitment rates with decent
quality of trial conduct;

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Why we are where we are (cont.):
 High level of “connection” between treating
physicians and patients resulting in good subject
retention rates in clinical trials;
 Low administrative and overall expenditures for
the conduct of clinical research business.

7. 2018, © CRG LLC, All Rights Reserved.
Our certifications

8. VOLODYMYR GALYUK
Director
DMYTRO RAZBOROV
Director of Clinical Operations,
Regulatory Affairs and Contracts Manager
CLINICAL OPERATIONS DEPARTMENT
- Clinical Project Lead
- Senior Clinical Research Associates
- Clinical Research Associate
IT DEPARTMENT
- IT Administrator
FINANCIAL DEPT.
- Chief Accountant
Total staff 13 persons:
 2 on regular employment;
 11 on contractual (freelance) basis.
FEASIBILITY DEPT.
- Feasibility Specialist
QUALITY ASSURANCE DEPT.
- QA associate
PROJECT MANAGEMENT
- Project Director
- Project Associate
LEGAL DEPT.
- Legal Affairs Lead
Yuriy BORTNYK
Clinical Research Director
ADMINISTRATIVE DEPT.
- Facilities Manager
TRAINING DEPT. (CRG SCHOOL)
- Training Lead
2018, © CRG LLC, All Rights Reserved.
Organizational structure

9. 2018, © CRG LLC, All Rights Reserved.
Corporate values
CUSTOMER SATISFACTION
Customers are our top priority!
RESPONSIBILITY
We are responsible for what we do and how we do it!
GOAL-ORIENTED
Every member of our company is goal-oriented and
we act as a whole!

10. 2018, © CRG LLC, All Rights Reserved.
Core activities
Clinical
Research
Organization
Site Management
Organization
Clinical
Trials of
Medical
Devices

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As a CRO we offer:
Management of
clinical trials
Medical support
of clinical trials
Clinical trial
logistics

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Management of clinical trials:
•Feasibility and
Start-up
Project
management
Clinical
monitoring
•Enrollment
Management
Regulatory
submissions
Risk
Management
Vendor search
and support
Consultancy
services
Pharmaco-
economic study
support

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Medical support of clinical trials:
•Development of study
documents (protocol,
questionnaires, ICFs,
etc); medical support in
CRF design
Medical liaison with Key
Opinion Leaders,
investigators, authorities
24/7 medical information
support on protocol,
compound and safety
issues
•Reconciliation of safety
events (SAEs, AEs of
special interest); tracking
and distribution of safety
reports (SUSARs, CIOMS)

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Clinical trials logistics:
•Customs clearance of
IMP and clinical
supplies
Local distribution of clinical
trial materials to sites

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As a Site Management Organization:
Support of Health Care Institutions to start clinical trials of
pharmaceuticals and medical devices
Support of clinical research sites in Clinical Trial Agreement (CTA)
negotiations
Continuous support of site from initiation in the study until site
closure
Staffing (hiring of qualified site coordinators, sub-investigators
and consultants)
Staff training (ICH-GCP, protocol and other clinical research
topics)
Enrollment support, patient compliance & retention
•Safety management

16. 2018, © CRG LLC, All Rights Reserved.
Medical
Device
Trials
Development
of study
materials
(protocol, IB,
ICF etc)
Clinical
Research Site
Development
Regulatory
and CTA
Management
Feasibility/
Start-up
Project
Management
Safety
Management

17. 2018, © CRG LLC, All Rights Reserved.
Current company activities:
 4 active international clinical trials: 1 in
maintenance and 3 in start-up phases (including 1
for medical device);
 Ongoing search for new business partners/clients;
 Launching proprietary CRG training school in
Ukraine for young investigators and CRAs.

18. 2018, © CRG LLC, All Rights Reserved.
We in Internet and social media platforms:
 Web-site:
crgroupe.com
 LinkedIn:
http://bit.ly/CRG-LLC
 Twitter:
http://bit.ly/CRGllc_TW
 Facebook:
http://bit.ly/CRGllc_FB

19. 2018, © CRG LLC, All Rights Reserved.
Contact us:
Organisation Name: Limited Liability Company “Carpathian
Research Group”
Address: vul. Samostiyna, 42-A, City of Uhryniv, Tysmenyts
District, Ivano-Frankivsk Region, 77400, Ukraine
Director (CEO): Volodymyr Galyuk
Telephone: +380 66 328 54 81
Fax: +380 67 231 86 96
Director of Clinical Operations: Dmytro Razborov
Telephone: +380 67 353 23 23
Clinical Research Director: Yuriy Bortnyk
Telephone: + 38 050 373 91 21
Email: info@crgroupe.com

20. 2018, © CRG LLC, All Rights Reserved.
With our WIN-WIN
approach we can be
Your solution in clinical
trials!