Autologous Supply Chain, Cell & Gene Therapy

There are two phases in the process:

1. A new study set-up in the system
The Sponsor will register a new study in the system by using the following information:

• Study details (study code number…) 
• Products, conditions for ex., acceptable temperature range, markers, activity level, etc
• Manufacturing/supply organization
• Sites and users [including at least read-only users, site pharmacists, IMP coordinator, CMO users, shippers, QP users for the release, monitoring CRO and Sponsor team]
  Information as per sponsor-process

If relevant, the system can be linked to S-CLINICA’s IRT and supply forecasting (system interfacing will be provided at no cost).

2. Study running phase
The system allows:

• Perform supply forecasting
• Ordering and scheduling can be from A to Z, including collection, shipment of materials, processing, return and injection. Required information for an Order will be provided by Sponsor.
• Tracking of request (orders) by authorized users (template to be provided by Sponsor)
• Consistency check by authorized representatives
• Authorized representatives from CMO will use the IRT to:
  
  

• Acknowledge receipt of request/order in the system
• Acknowledge manufacturing of the product
• Register dispatch advice when the product is shipped