Comparators are increasingly used in clinical trials to establish whether an investigational drug is more effective than an existing product. This growing demand for comparators can put additional demands on the clinical trial supply chain.
Fisher Clinical Services Russia received a request from a pharmaceutical company to perform urgent additional labeling of the comparator drugs which were being used in its clinical trials. This presented challenges to the team:
a) The volume of products that needed relabeling was high = 13,192 kits in total; 52,492 labels to be applied.
b) Existing packaging and labeling resources were committed to other projects at this time.
c) Timelines were tight.
Fisher Clinical Services Russia prioritised this project so as not to jeopardize the trial timelines. Additional temporary personnel were hired and trained to complete this large project. Label quantities were high and timelines were tight – a process was put in place to accommodate these challenges.
February 04, 2016:
The packaging department received the request from the client on additional labeling of the 13,192 comparator products.
Temporary personnel were hired and trained accordingly.
Labeling jobs were successfully completed. 13 192 kits were labeled, 52 492 labels were applied within 17 business days (776 kits and 3087 labels per day).
Labeled commercial products were approved and ready for distribution to sites.
“Fisher Clinical Services can-do approach helped them to fulfil this urgent labeling project on time.”