Learn From Our Years of Experience
View further information & resources
Adjudication of In-Transit and Clinical Site excursions
- Collect all data necessary to make a decision (e.g. temperature data; shipment, facility and site details; contents of shipment or refrigerator)
- Make a decision on the acceptability of the drugs using stability guidelines provided by the sponsor company
- Update the Interactive Response Technology (IRT) with the result of the adjudication
- If necessary, arrange for the material to be replaced
Compliance Management of Shipments
- Ensuring sites upload the temperature monitors by sending protocol specific alerts to sites
- Alerts can be event or calendar driven by the shipment and can include CRA/monitors, client etc.
Compliance Management of Sites
- Regular review of the site storage logs against reported site excursions
- Expedited processing of any unreported excursions to determine material acceptability
- Review of patient dosing for unreported excursions
Comprehensive GDP Monitoring (also referred to as End to End Monitoring)
- At a lot or med ID level, collection of temperature deviations from manufacture through dispensing to the patient
- Evaluation of cumulative deviations across all activities using stability data provided by sponsor
(manufacture ➝ receipt ➝ production ➝ storage at Almac and depots ➝ distribution ➝ storage at clinical sites)
Expert in a Box
Listen to our leading expert on temperature management, Sharon Courtney, as she discusses our Next Generation Temperature Management Services.
If you would like further information on Temperature Services please get in touch with us.