2009 Clinical Trial Logistic1 For clinical trials ONLY.

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Presentation transcript:

2009 Clinical Trial Logistic1 For clinical trials ONLY

2009 Clinical Trial Logistic2 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 Logistic3  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) Number of studies per year

2009 Clinical Trial Logistic4 Organization chart of CLINICAL TRIAL LOGISTIC General Director/ Chief accountant Managing Director for Logistics Head of Transportation Department Logistics Manager Moscow Delivery drivers (4 employees) Logistics Manager St. Petersburg Delivery drivers (2 employees) Storage Logistics Manager IT departmentTechnical Support Manager Managing Director for Operations and Business Development Head of Customs Logistics Department Customs Applicant Customs Broker Business Development Department Managing Director for Storage Operations Customer Service Specialists (3 employees) Head of Storage Department (pharmacist) Warehouse specialist (9 employees) Security (2 employees)Cleaner Customer Service Specialist St. Petersburg QC and Training Manager Accountant Accounting assistant Financial Director External QA expert Total: 35 employees

2009 Clinical Trial Logistic5 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 Logistic6 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 Logistic7 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 Logistic8 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 transportation Detached building occupied only by CTL Fire station 400 meters from the warehouse Police station – 200 meters No-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 Logistic9 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 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 Logistic11  363 m² of main IP ambient storage  Automatic control of temperature 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 Logistic12 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 Logistic13 AM storage area  276 pallets of main storage area  Automatic control of temperature 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 Logistic14 IP return area  1182 sq. m for returned goods in the new warehouse  Automatic control of temperature 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 Logistic15 Rostov-na-Donu N.NovgorodBelgorod Orel Voronez h Saratov Smolensk St. Petersburg Yaroslavl Chelyabinsk Yekaterinburg Tyumen Barnaul Novosibirsk Kemerovo Irkutsk Chita Khabarovsk Vladivostok Pskov Perm Kazan Samara Arkhangelsk Krasnodar Oms k Moscow Kursk Volgograd Astrakhan Ryazan Kaluga Bryansk Geography of our most frequent sites of destination

2009 Clinical Trial Logistic16 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 minutes Coding of each shipment IP and AM tracking system: Number of shipments per year

2009 Clinical Trial Logistic17 Contact us: Warehouse address: Moscow region, Khimkinskiy district, airport Sheremetievo I, warehouse #2 Telephone: Telephone/fax: