We have the capability to quickly develop and produce Clinical Trial LabKits, according to the clinical protocol and visit requirements, in a GMP accredited manufacturing facility with controlled access and video surveillance

• Each visit-specific lab kit includes specimen collection materials, prelabeledcollection tubes (labels are available in multiple formats anddesigns) and customized lab requisition form
• How do we make it easy for the investigator sites?
• We provide sites with a customized manual with specific instructionson specimen collection, handling, packaging and shipping;
  — For each visit, we include temperature - controlled shipping materialsand pre-formatted AWBs for the reverse logistics;
  — We monitor lab kit expiration dates and inventory depletion rates andsend automatic resupply alerts to sites;
  — Resupply kits have a turnaround of 5- 10 business days depending onthe site location.
• We provide our clients 2 options for the distribution of lab kits withspecialized courier services:
  — To investigator sites
  — Directly to clinical trial subject’s home

We remove the burden of shipments from investigator sites

• We transport specimens at ambient, refrigerated, frozen, dry-ice or combotemperatures
• We ensure the temperature stability of each shipment usingmonitoring devices
• Specimens are packaged in UN3373 materials to ensure IATA compliance
• Packaging materials contain multiple layers to ensure specimen integrity
• We prepare all import/ export documents for international shipments toclear customs
• We guarantee 24-hour domestic shipping; same-day delivery is alsoavailable on request
• For international shipments, we guarantee 48-hour shipping

We offer short-term and long-term storage in designated biorepositorieswith strict controlled access and monitored temperature conditions(ambient, refrigerated, frozen and cryopreservation)

• We strictly monitor the supply chain of custody for transport to theresearch centers, investigator sites or directly to patients’ homes
• We offer regulatory support for materials such as dangerous goods

International clinical trials may sometimes require additional labeling withinformation regarding shelf life or description of medicinal products indifferent languages

• International research drugs that are procured locally also require labeling
• We design, produce and apply labels in accordance with themanufacturer’s requirements
  — Label design for a specific medicinal product
  — Printing labels that will not peel off at low temperaturesfrom –15°C to –85°C
  — Shipment of medicinal products from the warehouse
• All processes are conducted in our GMP accredited manufacturing facilitywith controlled access and video surveillance

Reasons for return may be completion of research, expiration date, nonmarketableappearance, damaged packaging, incomplete documentationor unclear origin• We remove drugs, equipment and clinical trial materials fromresearch centers

• Before accepting cargo, we study the MSDS for each product to assessrisk for toxic substances, dangerous goods or opened packages
• After removing the cargo, we store it in designated quarantine zonesin our warehouse in temperature-controlled conditions
• Consignments are stored here until they are transferred for destructionto vendors who are certified for drug destruction

• Accurate Feasibility & Site Selection, an investment to ensure asuccessful study
• Regulatory Services - CTA submissions, notifications, substantial/nonsubstantialamendments and Safety Reporting to National CompetentAuthority, National Ethics Committee and Local Ethics Committees
• Translation of Study Documents - Trial synopsis, informed consentforms, patient materials, etc.
• Investigator Site Management & Study Management services
• Remote and on site monitoring services
• Vendor Management - Regional/local laboratories; shipments; IMP,medical device & other products storage.