Case Studies

Summary: When COVID hit, a sponsor avoided catastrophe for a key trial through rapid decision-making enabled by a system delivering fast, accurate forecasts and information.

Problem: In early 2020, Innovative Supply Solutions (ISS) was working with a pharmaceutical sponsor of an early-stage oncology clinical trial. In the middle of March, COVID-19 took hold in the United States and many other countries, and suddenly everything stopped. Sites closed as medical personnel were diverted to more urgent care. Patients stopped coming in for visits, either as a result of self-quarantine or fear of infection. This created immediate and massive disruption, and threatened to derail their entire trial.

Analysis: With constrained availability of drug, ISS was already working closely with the sponsor to forecast and manage supplies in a ‘just-in-time’ manner to optimize for inventory at over 100 clinical sites in multiple countries. When virtually all sites closed at once, the sponsor needed an immediate plan to ensure this population of cancer patients had uninterrupted access to drug. Fortunately, the US FDA and other regulatory agencies quickly signaled flexibility in allowing sponsors to adjust protocols. Sponsors immediately began to rapidly propose many possible modifications to the clinical plan, but could only truly evaluate and implement those where they could confidently assess the resulting impact on clinical supplies.

Actions: Leveraging the speed and accuracy of the ISS system, a Project Manager worked closely with the sponsor to evaluate several different options in real-time, as they were being discussed. Once a plan was selected, the system was reconfigured in a matter of minutes – whereas a traditional IRT system would have required change orders and potentially weeks to modify. In every case, the system calculated on-the-fly what was in inventory and what amount to ship, and did this at the trial level, depot level, and down to individual sites. To the great satisfaction of clinical staff, shipping schedules were even programmed around very limited windows when individuals would be available to receive shipments.

Outcomes: As a result of the above actions, the sponsor and their patients experienced the following:
 

• In less than a day (vs 2-3 weeks), a modified dispensing plan that included combining visits and changing protocols was proposed and approved. This enabled shipping orders to be placed before practically every other company, avoiding significant logistics backlogs that quickly emerged in the ensuing days.
   

• Distribution was also customized to the needs of individual sites and patients. This included both site to patient and even direct to patient delivery.
   

• Finally, by using a tool that provided the confidence to make quick decisions in a crisis, there have been no stockouts, no subjects lost and no sites lost. This may not only have saved patient lives, but could also have cost the sponsor hundreds of thousands of dollars.