2009 clinical trial logistic1 for clinical trials only

2009 Clinical Trial Logistic 1

For clinical trials ONLY


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 :


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


2006 – removal to the new facility (750 sq. m)


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2004 2005 2006 2007 2008

Number of studies per year


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


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


• 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:


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


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


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):


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):


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


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


AM storage area

276 pallets of main storage area

Automatic control of temperature +15+250 С

by conditioning system

Pest control


24 hours temperature monitoring and alarm

system



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


24 hours temperature monitoring and alarm

system



Video monitoring


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


• 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:

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Number of shipments per year


Contact us:

Warehouse address:Moscow region, Khimkinskiy district, airport Sheremetievo I, warehouse #2

Telephone:8-495-981-03-51 8-495-234-31-18

Telephone/fax: 8-495-737-53-83

e-mail:[email protected]

2009 clinical trial logistic1 for clinical trials only

Documents

clinical trial logistic5

clinical trial logistic3

clinical trial logistic1

local clinical trials

field of clinical trials

clinical trial logistic2

employees logistics

employees security