Trade.Information

Product Name: Clinical trial material

Product Description

AGEN Biomedical offers a complete service for the storage and distribution of clinical trial material to Investigator sites, along with reconciliation and destruction of returned goods. The logistics management of clinical trial materials includes:
 

• Receipt and tracking of supplies
• Storage of supplies in a secure temperature monitored environment
• Secondary packaging and labeling facilities
• Co-ordination of courier services and customs regulations
• Distribution of clinical trial supplies to Investigator sites
• Receipt of returned supplies from trial sites
• Reconciliation of all supplies on an ongoing basis
• Return of supplies to the Sponsor company or personal supervision of supplies destruction by an accredited waste facility

All procedures are conducted in accordance with internal Standard Operating Procedures, the ISO9001:2000 AGEN Quality Management System and the relevant regulatory guidelines.

SUPPLIES RECEIPT AND INVENTORY MANAGEMENT

AGEN works closely with the freight forwarding company, and through this association, we can ensure that your consignment is Customs and Quarantine cleared in a professional and expedient manner. We also have experience in assisting clients with gaining Australian Quarantine and Inspection Service (AQIS) licenses for importing goods into Australia.
AGEN will receive and verify the condition of all incoming material, check to confirm compliance with the given description and quantity, and confirm materials are received in the prescribed condition. AGEN will confirm receipt of delivery in writing to the Sponsor. Non-compliance will be reported immediately.
 

LABELLING AND SECONDARY REPACKAGING FACILITY

AGEN has a Therapeutic Goods Administration (TGA) license for labeling clinical trial material and has in-house label printing facilities. We will work with the Sponsor to ensure the label design is in compliance with protocol requirements and in compliance with the regulatory requirements of the TGA. Labels can be designed to withstand all storage conditions.
AGEN is also licensed to provide secondary repackaging services for clinical trial material.
 

CONTROLLED STORAGE CONDITIONS

AGEN can provide the following storage conditions for your clinical trial material:
 

• Ambient (18ºC to 25ºC)
• Refrigerator (2ºC to 8ºC)
• Freezer (-20ºC or -70ºC)

All Clinical Trial storage areas are continuously monitored for temperature using an electronic monitoring system (Citect), and storage condition data is reviewed on a daily basis. All storage areas are alarmed, with the range set to ensure there is sufficient warning of any temperature or humidity deviations, so that action can be taken to rectify the problem or move stock before the storage conditions reach the specification limits. The storage condition alarm system is linked to the security monitoring system to ensure that, if the alarm is raised outside working hours, AGEN’s security company will contact the Manager of the AGEN Clinical Trial Logistics Service and the Engineering Manager.
In the event of an interruption to mains power supply, fully maintained emergency power generators are automatically activated, ensuring temperature and humidity is maintained without interruption.
AGEN also has allocated secure storage facilities for all non-drug clinical trial materials such as Case Report Forms, laboratory supplies and drug delivery devices.
 

SECURITY

All clinical trial materials are held in AGEN’s premises at 11 Durbell Street, Acacia Ridge, Queensland. Each clinical trial storage facility is secured with strictly controlled smart card access entry, in addition to padlocked drug storage compartments. All storage areas are windowless and access is provided only to essential and appropriate Clinical Trial Logistics personnel.

PACKAGING & DESPATCH

AGEN will recall your clinical trial material from storage and pack them in accordance with the trial protocol and the requirements of each Investigator Site. The logistics officer will prepare the appropriate shipping documents, including Dangerous Goods Declarations if required. IATA compliant shipping material will be utilised, and temperature monitoring devices and validated temperature-specific shipping cartons will be used upon request. All goods despatched to sites will be accompanied by accountability documentation and proof of delivery for all out-going shipments will be sought. Sites will be re-supplied with clinical trial materials upon the request.

COURIER SYSTEM: DOMESTIC & INTERNATIONAL

From AGEN’s facility in Brisbane, supplies can be shipped overnight to all major centers in Australia and New Zealand. The most appropriate courier company will be determined with the Sponsor and agreed upon prior to the first shipment. This decision will be made based on various factors, including destination, cost, and transport conditions. Temperature data loggers are available for the shipment of temperature critical supplies. A protocol specific transportation plan will be designed with the Sponsor in the project initiation phase.

DRUG RETURN ACCOUNTABILITY & DESTRUCTION SERVICES

Expired or unused drug supplies can be returned to AGEN for storage or destruction. An accountability assessment will be performed on all returned stock and acknowledgement of receipt will be provided to the shipper. A report on the returned stock will be provided to the Sponsor and returned stock will be segregated from other supplies. At the conclusion of the clinical trial, clinical trial drug products will either be returned to the Sponsor or destroyed upon written authorization from the Sponsor. The destruction will take place at an accredited waste management facility and will be witnessed and documented by an AGEN representative. A destruction certificate will be provided to the Sponsor.

DOCUMENTATION & COMMUNICATION

All study files are meticulously maintained to ensure traceability. Through the lifetime of the contract with AGEN, the Sponsor will be provided with a monthly stock accountability status report detailing the clinical trial stock held by AGEN, all stock transfers and stock returns. Monthly temperature and humidity reports will also be provided.
On completion of the study, documents will be returned to the Sponsor, or archived in accordance with the AGEN Standard Operating Procedure for ‘Retention, Access and Disposition of Quality Records’ as directed by the Sponsor.
 

COMPETITIVE COSTS

A competitive quote will be prepared for each client based on the unique requirements of their project. Costs will be transparent and applicable for the life of the contract.

QUALITY SERVICE

AGEN’s objective is to adhere at all times to the standards of the United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and the ICH Good Clinical Practice guidelines.

The AGEN Quality Management System is ISO9001:2000 accredited and all activities performed by the AGEN Clinical Trial Logistics service are governed by internal Standard Operating Procedures (SOPs) which comply with the AGEN Quality Management System. In addition, protocol specific SOPs (PSOPs) are designed and implemented for individual contracts. These PSOPs govern all aspects of the service to be provided, and are designed during the project initiation phase in conjunction with the Sponsor. Dedicated Clinical Trial Logistics staff are trained in accordance with the AGEN SOPs and the PSOPs.

LICENCES

All procedures are conducted in accordance with:

• The ISO9001:2000 accredited AGEN Quality Management System
• United States Food and Drug Administration (FDA) regulations
• Australian Therapeutic Goods Administration (TGA) guidelines
  - AGEN’s TGA licence (no. 1035) incorporates storage, labeling and packaging of drugs for clinical trial use.
   
• Principles of the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP).
• Internal Standard Operating Procedures (SOPs)

TESTIMONIALS

Friendly, knowledgeable and efficient staff; a pleasure to work with regarding shipment, destruction and contractual issues"
Clinical Trial Manager of a large international pharmaceutical company.
"I just wanted to drop a quick line of thanks for the efficient communication and fast processing of our study drug shipment requests. If only all of our remote depots worked as well! Thanks and keep up the good work"
Clinical Trials Supply Manager of a large international pharmaceutical company

Company Details

• This company produces medical and veterinary diagnostic products based on monoclonal antibody technology. Special fields include human haemostasis and infectious diseases. Agenix Limited was listed on the Australian Stock Exchange in October... more