The Diabetes Challenge
We were asked by a relatively new client to source a recently launched diabetes product they had found impossible to obtain. In addition, they required the drug in a dosage form that was in short supply.
Speedy and successful outcome
We looked all over Europe and with some negotiating managed to allocate stock with a better expiry date than had been requested in the first instance. As often happens with complex clinical trials, there had been many changes of requirements along the way. Our project manager ensured that the client and suppliers were updated at all times to ensure a speedy and successful outcome.
Certificates of analysis
As we do with all orders, we checked every pack for batch number and expiry date on delivery to our warehouse, and although our QP decided to do extra checks on our SOPs with this consignment, we still managed to turn around the thousands of packs in under two hours. It was delivered to our client a week before their deadline in refrigerated transport, even though the outside temperature never reached above 5°C. All certificates of analysis and cold chain monitoring printouts were provided as a matter of course. In addition, we were also asked to provide the new approved drug delivery devices and specialist needles with all relevant certificates of compliance.
Our client later informed us that had we not been able to ‘pull this one out of the hat’, this trial would have had to be cancelled.