Mid-Sized Pharmaceutical Company Embraces Forecasting
There are times when clinical trial supply management takes a back seat to the many other urgent priorities leading up to study start. In one case, a supply chain manager position went unfilled at a mid-sized pharmaceutical company for a period of four months. The other members of the supply chain team were expected to pick up the slack left by the departing manager. And there was plenty of work to go around because two trials were each expecting 900 volunteers in 28 North American, European and Asia Pacific countries.
A problem waiting to happen
Having run a number of successful trials in the past, the company had a liberal policy for producing clinical material. Its main goal was to ensure each site had enough to fulfill dosing requirements; a modest level of overage was tolerated. This gave some people on the team full confidence that there would be plenty of investigational medication on hand at the clinical sites to meet the needs of the protocol.
Since the company never replaced its clinical supply manager no one was making use of the company’s forecasting software that would have enabled demand planning. And the interactive response technology set up for the trial was configured in a way that made it ineffective. Compounding these issues was the fact that this trial involved seven different medications including a comparator and the test article, which in this case was an injectible drug that required refrigeration.
With no solid demand planning, the trial ran into serious trouble with stock outs at some clinical sites and incorrect drug shipments showing up at others. The company employees who were handling supplies on top of their other responsibilities took a lot of heat from those in clinical operations. Tensions rose between the sides and distrust grew as the trial began to track behind company goals. As the wave of anger grew inside the company, it was quickly followed by resentment coming from personnel at the clinical sites who had to reschedule patient visits due to supply shortages and mistaken shipments.
With their clinical trial program in serous trouble, the company turned to the Clinical Supply Optimization team at Fisher Clinical Services. After quickly assessing the level of damage and the current enrollment and site activation plan, a Fisher Clinical Services employee went to work reconfiguring the interactive response technology and programming the unused demand planning software so it would start producing accurate forecasting statistics. In short order the company had a demand forecast and supply plan for the first study – the one in trouble – and for the second study, which was soon due to begin enrollment. The value of these plans came clear when data rolled in from the sites showing patients were getting exactly what they signed up for and the company was saving money by avoiding supply wastage. The initial relief that came with the forecasting plan increased as supplies were rebuilt to three months of inventory.
“She gives it her 300%”
Commenting on this project, the company’s associate director of supply chain said the Fisher Clinical Services employee “rescued” the first trial and there have been no supply problems in the second study. The employee has a “very special approach to her job,” the associate director said. “She gives it her 300% and I do mean 300%.”