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2009 Clinical Trial Logistic 2
CTL specializes in storage and distribution of investigational medical products, registered comparators and other study materials for international and local clinical trials.
We constantly extending the range of services providing to our customers. Every shipment
you entrust us with is a confirmation of your confidence in us. How we respond is a measure of our success. So we strive to meet and achieve your expectations every step of the way. Everyone that works for us has the responsibility for creating a smooth and efficient service.
We have great experience in the field of clinical trials and recognise that effective supply
chain event management is an important requirement for business success in today's markets.
About us :
2009 Clinical Trial Logistic 3
2004 – start of activities. Warehouse 400 sq. m
(5 clinical trials)
2007 – new warehouse facility opens in St.Petersburg (150 sq. m). Receiving Customs Broker License and
Pharmaceutical License
(85 clinical trials) 2008 – reconstruction and modernization of the new
warehouse facility in Moscow (additional 1182 sq. m).
(164 clinical trials)
2005 – developing and implementation of the special tracking program for IP and AM
(18 clinical trials)
2006 – removal to the new facility (750 sq. m)
(45 clinical trials)
0
20
40
60
80
100
120
140
160
180
2004 2005 2006 2007 2008
Number of studies per year
2009 Clinical Trial Logistic 4
Organization chart of CLINICAL TRIAL LOGISTIC
General Director/Chief accountant
Managing Director for Logistics
Managing Director for Operations and Business
Development
Managing Director for Storage Operations
QC and Training Manager
Customer Service Specialists
(3 employees)
Head of Storage Department (pharmacist)
Warehouse specialist(9 employees)
Security (2 employees)
Accountant
Accounting assistant
Financial Director
Head of Transportation Department
Logistics Manager Moscow
Cleaner
Logistics Manager St. Petersburg
Delivery drivers (4 employees)
Delivery drivers (2 employees)
IT department Technical Support Manager
Head of Customs Logistics Department
Business Development Department
Customs Applicant
Customs Broker
External QA expert
Storage Logistics Manager
Customer Service Specialist
St. Petersburg
Total: 35 employees
2009 Clinical Trial Logistic 5
In our drive to meet our customer needs we shall strive to ensure that all our actions are consistent with:
• International standards - GCP, GMP, GDP, IATA
• Own Standard Operating Procedures
• Quality Guidelines ISO 9001:2000
2009 Clinical Trial Logistic 6
• Receipt/Storage/Distribution of Investigational Products
• Receipt/Storage/Distribution of Ancillary Materials
• Storage of returned goods
• Transportation services (delivery of goods to investigation sites all
over Russia)
• Labeling/Re-labeling
• Reconciliation
• Customs Clearance
• Destruction of study materials
СTL services:
2009 Clinical Trial Logistic 7
Data safety:
• All information is kept in hard copy and electronic format
• RAID on server
• 24 hours security of precinct
• 24 hours security of the warehouse (our own security)
• 24 hours control of the technical conditions of the premises
2009 Clinical Trial Logistic 8
Advantages(I):1. CTL is located on the territory of Sheremetievo I : Minimization of transportation expenses for shipments delivery to the warehouse
Decreasing of damage risk during transportationDetached building occupied only by CTLFire station 400 meters from the warehousePolice station – 200 metersNo-break power supply
2. Own courier service GDP trained couriers own car fleet on-time delivery 3. Own Customs service customs clearance over 1 to 3 days obtaining import/export licenses delivery bio-samples from the sites under temperature control mode and consolidation them at the central depot export of bio-samples to a Central laboratory special prices for major clients
2009 Clinical Trial Logistic 9
4. Specialization on clinical trials
5. Ambient/cool/frozen storage of medical products with temperature control
6. Receipt and preparation for dispatch is performed in temperature controlled area
7. Ambient/cool/frozen delivery of medical products to investigational sites with temperature control
8. Separate conditioning of IP and AM premises
9. Special tracking IT program for IP and AM
10. Access to the facility building and storage areas only by authorized personnel
11. Video monitoring of all working areas
12. Receipt and dispatch of medical products over 24 hours
13. Destruction of IP and other study materials in licensed company
Advantages(II):
2009 Clinical Trial Logistic 10
14. Archiving of study documents
15. Own facility and courier services in St. Petersburg
16. Providing Customer with full IP and AM information
17. Great experience working with IVRS
18. Own Standard Operating Procedures
19. Well trained and highly motivated personnel 20. Regular internal/external audits
21. Confidentiality guarantee
22. High quality services for competitive prices
Advantages(III):
2009 Clinical Trial Logistic 11
363 m² of main IP ambient storage
Automatic control of temperature +15+250 С by conditioning system
Pest control
Fire-alarm and fire-protecting systems
24 hours temperature monitoring and alarm system
Non-dusting covering on the floor
Washable walls, ceiling, shelves
Video monitoring
IP storage area
2009 Clinical Trial Logistic 12
IP cool storage area
Cool storage +2+8º С in validated
refrigerators
72 m³ main cool storage area
12 m³ cool packing area
8 m³ cool quarantine area
24 hours temperature monitoring
and alarm system
Video monitoring
2009 Clinical Trial Logistic 13
AM storage area
276 pallets of main storage area
Automatic control of temperature +15+250 С
by conditioning system
Pest control
Fire-alarm and fire-protecting systems
24 hours temperature monitoring and alarm
system
Non-dusting covering on the floor
Washable walls, ceiling, shelves
Video monitoring
2009Clinical Trial Logistic 14
IP return area
1182 sq. m for returned goods in the new
warehouse
Automatic control of temperature +15+250 С
by conditioning system
Pest control
Fire-alarm and fire-protecting systems
24 hours temperature monitoring and alarm
system
Non-dusting covering on the floor
Washable walls, ceiling, shelves
Video monitoring
2008 Clinical Trial Logistic 15
Rostov-na-Donu
N.NovgorodBelgorod
Orel
Voronezh
Saratov
Smolensk
St. Petersburg
Yaroslavl
Chelyabinsk
Yekaterinburg
Tyumen
Barnaul
Novosibirsk
Kemerovo
Irkutsk
Chita
Khabarovsk
Vladivostok
Pskov
Perm
Kazan
Samara
Arkhangelsk
Krasnodar
Omsk
Moscow
Kursk
Volgograd
Astrakhan
Ryazan
Kaluga
Bryansk
Geography of our most frequent sites of destination
2009 Clinical Trial Logistic 16
• Tracking and accountability of receipt
• Reporting of received goods to the Customer
• Tracking and accountability of goods dispatched to
investigational sites
• Reporting of expiry dates of IP and AM to the Customers
• Tracking and accountability of goods returned from
investigational sites
• Minimization of human mistakes
• Processing of shipment requests in 10-30 minutes
• Coding of each shipment
IP and AM tracking system:
0
1000
2000
3000
4000
5000
6000
7000
8000
2004 2005 2006 2007 2008
Number of shipments per year
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