ISS Nexus making a real world difference
The ISS Story
Navigating the COVID-19 Chaos
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.
The Power of a More Accurate Forecast
Client Story: The pharmaceutical sponsor of a large, multi-country, 100+ site Phase III study was concerned that the Clinical Research Organization they were contracted with was providing input and advice based on a faulty recruitment forecast. The sponsor approached ISS directly and requested a new forecast using the ISS platform and to provide a side-by-side comparison to the CRO’s model. ISS performed the analysis using the sponsor data, and determined that recruitment would run slower than expected and the study would likely take 3 months more to complete than what was forecast by the CRO.
Outcomes: ISS correctly and accurately predicted the actual trial length (3 months beyond the CRO forecast). Thanks to the ISS information, this was not a surprise to management, and the sponsor was able to react appropriately to ensure a smooth close out to the study.
Client Story: A biotech client of ISS was in the middle of their Phase II study when their Clinical Supply team learned that the study design was going to be changed, increasing duration by 6 months. The existing inventory expiry date was too short, and the initial conclusion was they would need a new $400,000 manufacturing campaign. The client came to ISS to see what could be done.
Outcomes: In a single face-to-face meeting, ISS ran scenarios and analyzed the results. Within two hours, ISS produced a recommended clinical supply plan that enabled the company to work with existing drug inventory until new stability data would become available, avoiding the costly new production campaign. The client approved the changes and successfully implemented them, completing the trial on time and under budget.
Why ISS Nexus?
One platform to make clinical trials operations easy and successful