Russia presents several challenges for conducting clinical trials due to its vast territory with different climate zones, centralized healthcare system, and new regulations from the Eurasian Economic Union. Logistics of importing and distributing study drugs and supplies throughout Russia requires special considerations including customs clearance, packaging and labeling, storage and temperature-controlled transport, and accountability of inventory. Outsourcing to a qualified clinical research organization and warehouse can help address these challenges through regulatory expertise, qualified staff and facilities, temperature-controlled storage and transport, and coverage of Russia's major cities.

1. FACING THE CHALLENGES OF
CLINICAL TRIALS IN RUSSIA
Natalia Vostokova
Chief Operating Officer
IPHARMA LLC
(CRO of ChemRar group)
Oksana Karavaeva
Director of Clinical Operations
IPHARMA LLC
(CRO of ChemRar group)

2.  Customs regulations
 Vast territory
 Different climate zones
 Lack of equipment/storage on site
 Language requirements
CHALLENGING GEOGRAPHY FOR CLINICAL TRIALS
 Population over 172 million
 Centralized healthcare system
 Need for importation/customs clearance
 Shipment duration up to 72 hours
 High price of shipments
 Temperature control/cold chain
 Central storage and distribution
 Re-labeling
 High recruitment
 Limited access to innovative treatments
RUSSIA AND EAEU
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3.  Study drug
 Comparator
 Study materials
 Ancillary supplies
 Equipment
 ConMeds
LOGISTICS IN CLINICAL TRIALS
Inbound shipments, importation,
customs clearance
Packaging and labeling
Storage and cold chain
logistics
Shipments and
temperature control
Accountability, inventory,
and IWRS
Return and destruction
Outbound shipments,
exportation Full cycle of clinical development
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4. NEW REGULATIONS OF EAEU RELEVANT TO
CLINICAL TRIALS LOGISTICS
Good Clinical Practice (GCP) – ethical and scientific standard
for the design, conduct, performance, monitoring, auditing, recording,
analyses, and reporting of clinical trials that provides assurance that
the rights, safety, and wellbeing of trial subjects are protected , and
the clinical trial data is credible and accurate
Good Distribution Practice (GDP) – part of QA system that guarantees
the quality of medicinal products at all stages of distribution, including storage
and shipment, from manufacturer to parties that conduct manufacturing,
wholesale, retail and dispense to population (including medical institutions)
Good Manufacturing Practice (GMP) – part of QA system that guarantees
the consistency of manufacturing and control according to the applicable quality
standards and according to the registration dossier requirements, clinical trial
protocol and product specification
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5. CHALLENGE #1 – STUDY LAUNCH TIMELINES
Preparation
months1-2
• IB, Protocol, ICF
• Sites & Investigators
• Local insurance
• CMP Quality
CTA
Review
Clinical Trial Application Licenses
APPLICANT MoH Experts MoH APPLICANT MoH
months2.5 month<1
Decision
Scientific
Expertise
Ethical
Expertise
Study Drug Import
Lab Samples Export

6. • Purchase
• Import commercial
• Import for clinical trial
CHALLENGE #2 – COMPARATOR AND SUPPLIES
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7. • Re-packaging
• Re-labeling
• Additional labeling
CHALLENGE #3 – PACKAGING AND LABELING
Appendix # 13 to the Good
Manufacturing Practice of EAEU
REQUIREMENTS to medicinal
products for clinical trials
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8. SELECTION OF WAREHAUSE (THE MAIN CRITERIA)
• Qualification of WH in general (audit passed successfully)
• Location of WH
• The scope of services
• WH equipment's
• Specialized own courier service
• The price of services (the lower price is preferable)
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9. QUALIFICATION OF WAREHOUSE
• Certificated by ISO 9001:2008
• Pharmacy license for purchasing and distribution of medicine
• Fully comply with Local and International industry standards (GxP)
• SOPs and high quality control system
• Internal and external audits, inspections
• Thoroughly trained and qualified in industry team
• Guaranteed 24/7/365 temperature control
• Guaranteed 24 hour turn-around response
• Archiving of documents within 15 years
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10. LOCATION OF WAREHOUSE
• Moscow (St Petersburg)
• Additional WH in Ukraine, Belorussia and etc.
• Near the main airports (Vnukovo (VKO), Domodedovo (DME),
Sheremetyevo (SVO) and enabling fast and relievable delivery to
clinical sites throughout Russia and Customs Union
• Near location to Policy and Fire station
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11. THE SCOPE OF SERVICES
• Regulatory support and customs clearance
• Temperature controlled storage and delivery of the study drug and
materials
• Local procurement of study drugs and clinical trial materials (including
laboratory materials purchasing)
• Additional labeling/relabeling of study drugs
• Return, calculation, storage and destruction of IP and study materials
• Additional activities:
- Organization of named patient programs
- Shipping of biological materials (ambient, frozen) and Export
- Taxi for the patients
- Leasing/ purchasing of medical equipment 11

12. THE SCOPE OF SERVICES
• Regulatory support and customs clearance:
1. Preparation and submission of dossier for MOH IP
and Study Materials approval
2. Fasting receiving Import/Export Licenses (within 10 days)
3. Discussion of risk supply delays
4. Shipment control and negotiation with the Sender
5. Custom clearance within 3 days
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13. THE SCOPE OF SERVICES
• Temperature controlled storage and delivery of the study drug:
1. ambient: +15°C +25°C
2. refrigerated: +2°C +8°C
3. frozen: -15°C -25°C
4. deep frozen: -40°C -90°C
5. LN2: -196°C
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14. THE SCOPE OF SERVICES
• Local procurement of study drugs and clinical trial materials (including
laboratory materials purchasing):
1. Direct Agreements with the Manufactures
2. Fast negotiation, purchasing, delivery, reconciliation and
additional labelling (if needed) (within one week)
3. Possibility to ship comparator/ concomitant medication without
customs to Kazakhstan, Belarus (as a part of Customs Union)
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15. THE SCOPE OF SERVICES
• Additional labeling/relabeling of study drugs:
1. Fully compliance with GMP, Local Regulation, SOP
2. Performing additional labelling within very short time
3. Double quality control system during additional labelling
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16. THE SCOPE OF SERVICES
• Storage, return, re-calculation and destruction of IP and study
materials:
1. Fully compliance with GxP, Local Regulation, SOP
2. Receipt, reconciliation of used/unused or expired IP from sites
3. Safely transportation to the Certified and audited destruction
facility
4. Receiving of the official Destruction Act
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17. WAREHOUSE EQUIPMENT'S
• Certified, calibrated and validated equipment's
• Different Temperature controlled storage equipment's
• Temperature control system (24/7/365)
• Temperature monitoring system with GSM alarm messaging
• Video monitoring of working areas
• Access control with 24/7/365 security video
• Electronic keys access to main storage areas
• Fire prevention and alarm system
• Back-up power generator covering all depot systems
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18. SPECIALIZED OWN COURIER SERVICE
• Possibility to cover all major cities in Russia
• Guaranteed on-time and safety distribution to sites
• Using validated insulated shipping containers
• Properly T° controlled ambient, +2/+8°C and dry-ice shipments during
transportation using validated T° loggers (Tempmate, TT4, Libero, etc.)
• Hand-to-hand and just-in-time delivery
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19. Natalia Vostokova, PharmD
Chief Operating Officer
Mobile: +7 (926) 098-36-33
NV@ipharma.ru
IPHARMA LLC (ChemRar group)
5, Nobel street, Moscow, 143026, Russia
Tel.: +7 (495) 276-11-43
Fax: +7 (495) 276-11-47
Web: www.ipharma.ru
THANK YOU FOR YOUR ATTENTION!
Oksana Karavaeva, MD
Director of Clinical Operations
Mobile: +7 (926) 098-92-42
OVK@ipharma.ru
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