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.
Avoiding Cost and Making a Clinical Supply Hero
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.