Clinical Trial Logistics

AMI Express provides a globally coordinated, full range, biological sample retrieval and delivery service. Services include:

Temperature controlled packaging, including dry ice supply service when required, to meet required temperature specifications for biological sample shipments

Pre-trial training for investigator sites in local languages which covers printing airway bills, proper shipment packaging, how to handle dangerous goods

Dry ice is ‘topped off’ at intermediate shipment locations. Where required, gel packs are also replaced and temperature monitoring equipment is checked throughout the route

Regulatory and customs support to quickly navigate shipments through the often complicated clearance process

Assistance with government agency compliance in order to handle controlled substances, infectious material, radio labeled materials and other dangerous goods

Time & Temperature Sensitive Drug Shipments

AMI Express provides pre-conditioned temperature control packaging, transport and tracking of time and temperature sensitive drugs with the support of:

AMI Express is linked with its partners’ cutting edge information technology system, that records key milestones in real time and is linked to our tracking system that provide live updates 24 hours per day, 7 days per week from any location in the world. It allows AMI Express via It’s partners to ensure all shipments are delivered on time within specification

Knowledgeable and experienced regulatory and trade compliance teams:

• Consult on best import and export processes as well as packaging

• Offer product classification consultancy

• Review and validate documents used for the customs clearance process and agency release prior to shipping to ensure compliance with local regulations

• Qualify packaging solutions by conducting lane mapping and verification to make sure temperature stability is maintained in real world conditions

Pre-qualified packaging solutions for all payloads and temperature ranges along with appropriate temperature monitoring technology

Global Project Management

AMI Express has an experienced project management team with a clear understanding of all aspects of the clinical trial process. A dedicated project team along with it’s global partners manages day-to-day study activities and progress reporting. The project management team provides:

COMPREHENSIVE PLANNING

– Defines project scope

– Prepares comprehensive project plans with detailed timelines

– Continually anticipates and addresses any issues or challenges

CLEAR COMMUNICATION

– Serves as central point-of-contact for clients and AMI Express team

– Provides regular status reports

– Organizes and oversees project meetings

CAREFUL MANAGEMENT

– Provides timely and thorough responses to client requests

– Clarifies client expectations and educates the project team

– Respects and follows client-specific guidelines

– Suggest system improvements and implements changes as needed

SKILLFUL EXECUTION

– Ensures the receipt of clinical trial supplies are processed in time and in specifications

– Manages collection, reconciliation, storage and destruction of returns

– Ensures accurate invoicing to clients for services completed

RELIABLE CONTROL

– Process governed by more local custom and FDA Standard Operating Procedures.

COMPLETE DOCUMENTATION AND CLOSURE

– Maintain and archive all project documentation

– Hold a project closeout meeting with client

– Review and document lessons learned