Скачать презентацию For clinical trials ONLY 2009 Clinical Trial Logistic Скачать презентацию For clinical trials ONLY 2009 Clinical Trial Logistic

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For clinical trials ONLY 2009 Clinical Trial Logistic 1 For clinical trials ONLY 2009 Clinical Trial Logistic 1

About us : CTL specializes in storage and distribution of investigational medical products, registered About us : 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. 2009 Clinical Trial Logistic 2

Ø 2004 – start of activities. Warehouse 400 sq. m Ø Number of studies Ø 2004 – start of activities. Warehouse 400 sq. m Ø Number of studies per year (5 clinical trials) 2005 – developing and implementation of the special tracking program for IP and AM (18 clinical trials) Ø 2006 – removal to the new facility (750 sq. m) (45 clinical trials) 2007 – new warehouse facility opens in St. Petersburg (150 sq. m). Receiving Customs Broker License and Pharmaceutical License Ø (85 clinical trials) Ø 2008 – reconstruction and modernization of the new warehouse facility in Moscow (additional 1182 sq. m). (164 clinical trials) 2009 Clinical Trial Logistic 3

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

In our drive to meet our customer needs we shall strive to ensure that 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 5

СTL services: • Receipt/Storage/Distribution of Investigational Products • Receipt/Storage/Distribution of Ancillary Materials • Storage СTL services: • 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 2009 Clinical Trial Logistic 6

Data safety: • All information is kept in hard copy and electronic format • 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 7

Advantages(I): 1. CTL is located on the territory of Sheremetievo I : Minimization of 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 Logistic 8

Advantages(II): 4. Specialization on clinical trials 5. Ambient/cool/frozen storage of medical products with temperature Advantages(II): 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 2009 Clinical Trial Logistic 9

Advantages(III): 14. Archiving of study documents 15. Own facility and courier services in St. Advantages(III): 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 2009 Clinical Trial Logistic 10

IP storage area · 363 m² of main IP ambient storage · Automatic control IP storage area · 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 2009 Clinical Trial Logistic 11

IP cool storage area · Cool storage +2+8º С in validated refrigerators · 72 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 12

AM storage area · 276 pallets of main storage area · Automatic control of 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 2009 Clinical Trial Logistic 13

IP return area · 1182 sq. m for returned goods in the new warehouse 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 2009 Clinical Trial Logistic 14

Geography of our most frequent sites of destination St. Petersburg Pskov Smolensk Moscow Bryansk Geography of our most frequent sites of destination St. Petersburg Pskov Smolensk Moscow Bryansk Yaroslavl Arkhangelsk Orel Kursk Kaluga Belgorod N. Novgorod Kazan Ryazan Perm Rostov-na-Donu Voronez h Oms k Saratov Volgograd Samara Krasnodar Yekaterinburg Novosibirsk Astrakhan Kemerovo Chelyabinsk Tyumen Barnaul Khabarovsk Irkutsk 2008 Clinical Trial Logistic Vladivostok Chita 15

IP and AM tracking system: Number of shipments per year • Tracking and accountability IP and AM tracking system: Number of shipments per year • 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 2009 Clinical Trial Logistic 16

Contact us: Warehouse address: Moscow region, Khimkinskiy district, airport Sheremetievo I, warehouse #2 Telephone: 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: info@ct-logistic. com 2009 Clinical Trial Logistic 17