A large pharmaceutical sponsor approached Fisher Clinical Services for assistance with a large trial they planned to run over a 48 month therapy treatment period that was going to involve 24,000 patients in 14 countries and projected an enrollment rate of approximately 1,000 patients per month.

The packaging requirements for the study was a triple dummy design with three products on each card.  Original projections for the project estimated over 1,500 shifts per year, using traditional bottle or 10-day card design.  In addition, the labeling requirements would require a creative solution to automate the process to maintain timelines and capture efficiencies.

The solution was a customized process approach that would allow for a minimum operational output of two kits per minute and required optimization of the primary blistering equipment. The novel design approached would provide a kit per patient month with seven-day cards, including five cards in each kit totaling a 35-day supply per patient. We used barcode technology to apply and verify global booklet labels as well as on-line printing and application of variable data.  The only manual step in the solution involved placing five cards into a monthly patient kit and tamper sealing. The complete kit contents were verified with one scan and the innovative window design removed the requirement for a coded lab on the carton.

Fisher Clinical Services provided the client with an approach that had the average kit output of three to four kits (15-20 cards) per minute.  The cost savings realized were estimated by the client to be >50% over traditional clinical trial packaging.