1. Global Clinical Trials, LLC
General presentation
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2. History
• 2001 first clinical operations in Russia
• 2003 US headquarters opened in Princeton, NJ
• 2006 clinical operations office in Bulgaria established
• 2006 exclusive partner of “The White Nights” international ophthalmology
congress in CIS
• 2007 new offices in Ukraine and Romania
• 2008 FDA visit to GCT warehousing facility in Russia while examining investigative• 2008 FDA visit to GCT warehousing facility in Russia while examining investigative
sites participating in a GI phase III project
• 2012 first Russian government-sponsored pharmaceutical clinical development
program
• 2014 new office in Serbia
• Present, CEE/CIS: GCT is a full-service regional CRO, conducting FDA/EMA/GCP
compliant phase I—IV/PK/BE clinical research of biopharmaceuticals, medical
devices and combination products in Russia, Ukraine, Serbia, Romania (EU),
Bulgaria (EU) with 10+ years experience in the industry
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3. Eugene Selivra,
MD, CEO
Strategic
Development
Business
Development
Quality Assurance
Jeffrey Apter, MD,
President
Global & Regional Management
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General Director,
Romania
General Director,
Bulgaria
General Director,
Russia
General Director,
Ukraine
General Director,
Serbia

4. Services: full & functional
• Feasibility analysis and site
selection
• Regulatory support:
– clinical study approval,
– import/export licenses,
– local insurance, etc.
• Translation and cultural adaptation
of clinical study documentation
• Local SAE management
• GCP/ FDA compliant warehousing
in Russia:
– ambient, refrigerated, frozen (-30C, -
70C),
– 400+ sq. m. facility close to the airport
in St Petersburg,of clinical study documentation
• IM organization
• Global and regional project
management
• Site administration
• Clinical monitoring
• Logistics
• QA and QC
• PI/site contracts and payments
in St Petersburg,
– emergency auxiliary power and
computer temperature and monitoring
controls
• Vendor management:
– Central laboratory,
– QP release,
– EudraVigilance, etc.
• Pre-clinical studies for registration
in Russia
• Others
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5. Region & GCT: key advantages
Quality and
Compliance
Enrollment
and regulatoryand regulatory
approval
speed
CostExperience
Reputation
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6. Quality and compliance
• Region:
– GCP standards implemented into the legislation
– Among the five most inspected countries (US, Canada, UK,
Germany), Russia has the lowest rate of FDA findings
• GCT:• GCT:
– 20+ external project and system audits passed
– QA system based on: internally developed SOPs; regular
GCP trainings of staff; corporate and project-related trainings;
internal audits (offices, facilities, departments, projects, etc.);
vendors’ qualification
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7. Fast study setup and recruitment
• Region:
– rapid enrolment due to the huge urbanized population size
(223m in 5 countries) and centralized healthcare system
– high retention and low drop-out rate
– large pool of treatment-naive subjects
– diverse and extremely compliant patient population– diverse and extremely compliant patient population
– regulatory approval from 2-3 months in Romania and Bulgaria to
3-4 months in Russia, Ukraine and Serbia
• GCT:
– demonstrated ability to deliver patients on & ahead of schedule
– history of 100% CT regulatory approval
– realistic timelines and risk mitigation strategies
– site/PI agreements conduct in beforehand
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8. Competitive price
• Region with a reasonable cost
advantage:
– clinical costs in Russia are only
40% of costs in the US
• GCT:
– flexible contracting and payments
options (milestone based fixed
price contracts; variable price
fixed unit contract; T&M contract)
– negotiable pricing
60
80
100
Average cost of clinical trials -
international benchmarks (USA = 100)*
– negotiable pricing
– discounts for customer’s loyalty
and volume
– cost-effective travel policy
– scenario approach
– various vendors
– PI grants negotiations
– budgets in Sponsor’s formats
• * Source: PwC Analysis
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0
20
40

9. Therapeutic experience
• Region:
– highest incidence rates in respiratory, cardiovascular, GI,
urogenital, CNS, and ophthalmology
– highest mortality caused by cardiovascular, oncology and trauma
– key opinion leaders in each therapeutic area
– medical institutions specialized in treatment of certain diseases
• GCT:
– solid experience in Phase II/III clinical studies in ophthalmology,
neurology and psychiatry, GI, oncology, metabolic, woman’s
health, others
– close established relations with KOLs in the region
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10. Strong reputation
• Acceptance of data by foreign bodies:
2/3 of FDA/EMA approved drugs studied within international clinical
trials are placed in part in Russia and the percentage is
increasing (2010 – 29%, 2011 – 33%, 2012 – 37%, 2013 – 65%)
• Proven GCT’s Clients’ satisfaction:
TestimonialsTestimonials
Repeat business: US Pharma gave us 6 late-stage projects within
10 years
Various types of customers: Big Pharma, mid-sized and small
Biotech, Medtech, Cooperative Groups and Foundations from
US, EU, Australia, Russia, Asia
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11. The Management team and
the CRAs are physicians,
and the lead monitor for our
breast cancer trial is an
oncologist. The monitoring
and the reporting of data
are exceptional. The team
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are exceptional. The team
is extremely responsive to
the trial demands and
always performs at an
optimal level.

12. Extra advantages of GCT
• Executive oversight
• Confidentiality of data & security of infrastructure, computer
systems
• Medical, pharmaceutical, biological background of clinical staff
• Strong project management & team work
Accurate• Accurate feasibility and realistic timelines expectation
• Local expertise
• Regional focus with international reach
• In-house personnel
• Financial stability
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13. GCT Business Development
+7 812 703 0008 (Russia)+7 812 703 0008 (Russia)
+1 609 921 6868 (US)
bd@gctrials.com
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