Reception of IMP from manufacturer :
- quarantine
- verification
- recording
Storage :
- at ambient temperature, +4 to +8 °C, or - 20°C
- Areas with controlled access and atmosphere
- Dedicated areas identified for each project
- 24 h /24 and 7days a week monitoring (telesurveillance)
Tracking of expiry dates
- Alert programming
- Informing client
Reception of request for sending (IVRS, fax, mail) and preparation of shipment
- Treatment of request within the 24hrs or same day if urgent
- Preparation of documents : request for shipment, analysis certificates, release certificates
Preparation and verification of shipments including 100% quality control
- Packaging used adapted to each study in order to guarantee the integrity of products that are transported as well as minimising transport costs (weight/volume ratio)
- Management of the cold chain : use of approved isothermic packaging
- Recording of release
Distribution to investigation centres
- Organisation of shipment (Express, courier service)
- Tracking of the delivery
- Management of acknowledgement receipts
- Resupply to same sites if required and requested by client
Organisation of returns at study end :
- Organisation of pick up from site
- Verification at reception and recording
- Reconciliation possible
- Possibility of storage of returns in area with controlled atmosphere (if required)
Destruction of IMP or return to sponsor at study end :
Destruction certificate per project
Centralised randomisation (IVRS) in partnership with Cardinal Systems