Overview of Service Capabilities

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VORTEX CLINICAL SERVICES
Overview of Service Capabilities
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VORTEX

• Founded 2005 - Private and Management Owned
• 4 Years of Growth and Success
• Extremely High Level of Client Retention
• 600 Employees
• Regional Specialised Call Centers
• USA 375
• Europe Asia 125
• Corporate Solutions Team
• USA, Europe Asia 100
• 4,000 Global Service Partners
• 24 x 7 x 365

• Founded 2005 - Private and Management Owned
• 5 Years of Growth and Success
• Extremely High Level of Client Retention
• Own Distribution Centre
• VORTEX DEPOT RUSSIA - Moscow
• VORTEX DEPOT BELARUS- Minsk
• VORTEX DEPOT UKRAINE - Kiev
• VORTEX DEPOT KAZAKHSTAN- Astana
• Corporate Solutions Team
• Global Service Partners

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About VORTEX

• VORTEX is a specialized Distribution Center
  which successfully conducts business on the
  territory of the Russian Federation and abroad.
• We are devoted to our customers and offer them
  high level of quality and reliability in services
  in the sphere of the Clinical Trials.
• Our High-Qualified Personnel provides effective
  activities on the most difficult areas of CIS.

VORTEX - Delivering innovative solutions -
Industry Intelligence - And complete peace of
mind
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Areas of Focus

• 2006 - VORTEX Distribution Centre in Russia
  Development
• 2007 - VORTEX Distribution Centre in Belarus
  Development
• 2008 - VORTEX Distribution Centre in Kazakhstan
  Development
• 2009 - VORTEX Distribution Centre in Ukraine
  Development

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VORTEX Services

• Pre-study Activity Process
• Gathering Full Documents Package For Submission
  Process
• Clinical Translations
• Study Set-up Process
• Preparation Of Documentation And Submission To
  Ec/Ca.
• Final Approval Submission.
• Query Answering (If Applicable)
• Getting Of Importation/Exportation Licenses,
• Additional Certificates (If Required)

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VORTEX Services

• PROCESSING and DEVELOPING
• Importation/Exportation
• All Essential Medication, Materials and Equipment
  (Study Drug, Vaccines,
• Laboratory Kits, CRFs, All Medical
  Equipment, etc.)
• Own Customs Broker Activity
• Coordination Of Dispatch, Invoice Approval and
  Management Of Customs
• Clearance Processes
• Timelines do not exceed 3 working days
• Receipt, Checking and Stock-Tracking
• Active Troubleshooting System
• Next Day Readiness to Dispatch
• Full-Time Inventory
• Storage and Facilities
• Temperature and Humidity Control with Strict
  Automatic Management System
• Warehouse Designed and Equipped for Separate
  Storage of Different Study

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VORTEX Services

• Re-Labeling Process
• Validated Premises / Chambers
• Experienced Staff
• Distribution / Return / Recall / Transfer Process
• Own Courier Company operating on the territory of
  Russia,
• Ukraine, Belarus and Kazakhstan
• Close Contact With Investigator Sites located in
  Russia, Ukraine,
• Belarus and Kazakhstan
• Service Trials With Strict Temperature Control
• 15 25C / 2 8C / -20 5C / -70 5C /
  -86C

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VORTEX Services
Cold Chain Capabilities

• VORTEX is able to provide packaging and
  key supplies on a global basis
• Work with suppliers that have global
  manufacturing capabilities, particularly in the
  emerging markets - Regional or local climate
  specific shipping systems
• All packing materials are fully
  validated and have pack-out instruction diagrams
• Validated / Testing Rooms and Cooling
  Chambers for special packaging
• 15 25C / 2 8C / -20 5C
  Shippers with Summer, Winter and Year round
  profiles. Dry Ice units, ambient systems and
  validated controlled temperature products
• Validated and Calibration Temperature
  logging devices
• Available for ambient, refrigerated and frozen
  shipments, ranging from simple visual systems to
  detailed logging

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VORTEX Services

• Destruction Process
• Contract With Certificated Destruction Company
• Compliance With Regional Legislation
• Provide All Necessary Documentations

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Complete Cycle
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Quality Assurance Overview

• SOPs to Ensure Maximum Efficiency Quality

• Quality Control Manual

• Disaster Recovery Plan

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Communications
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VORTEX Staff
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MAIN OFFICE 22 B. KARETNIY per. H1 RUSSIA,
MOSCOW, 127057 PHONE [phone] FAX 7
495 665 47 62