Case Study: Avoiding Costly Production with ISS Nexus
Introduction: A Critical Study Design Change
In the world of clinical trials, unexpected changes can lead to significant challenges, particularly when it comes to clinical supplies. Such was the case for a biotech client in the midst of their Phase II study. Midway through the trial, their Clinical Supply team learned that the study design was going to be altered, extending its duration by six months. This change had a ripple effect: the existing drug inventory had an expiry date that was now too short, and the initial conclusion was that a new manufacturing campaign, costing $400,000, would be necessary. Faced with this daunting prospect, the client turned to ISS for a solution.
Challenge: Balancing Inventory Constraints and Trial Extension
The extension of the study by six months introduced a critical problem—the existing inventory was set to expire before the trial could be completed. The client was faced with a choice: either initiate a costly new manufacturing campaign or find a way to extend the use of the existing inventory. The financial implications were significant, with the new manufacturing run estimated to cost $400,000. The client needed a quick, cost-effective solution that could keep the trial on track.
Approach: Rapid Scenario Analysis with ISS Nexus
Understanding the urgency of the situation, the client approached ISS to explore alternative solutions. ISS quickly organized a face-to-face meeting with the client's team, where they utilized the full capabilities of the ISS Nexus platform to run various scenarios in real-time.
1. Scenario Modeling: During the meeting, ISS Nexus was used to model multiple supply scenarios, taking into account the extended trial duration and the existing inventory constraints. This rapid modeling provided the client with a clear view of the possible outcomes and the associated risks of each option.
2. Supply Plan Optimization: Leveraging the platform’s advanced analytics, ISS developed a clinical supply plan that allowed the client to use their existing drug inventory until new stability data became available. This approach not only minimized the risk of drug shortages but also avoided the immediate need for a costly new production campaign.
3. Real-Time Decision Making: The speed and accuracy of ISS Nexus enabled the client to make an informed decision in a single meeting. Within two hours, a viable plan was developed, reviewed, and approved by the client’s team.
Results: Cost Savings and On-Time Completion
Thanks to the rapid response and the capabilities of the ISS Nexus platform, the client was able to achieve several key outcomes:
- Avoided $400,000 Manufacturing Campaign: By utilizing the existing drug inventory and relying on new stability data, the client completely avoided the need for a new manufacturing run, resulting in significant cost savings.
- On-Time Trial Completion: The optimized supply plan ensured that the trial could proceed without delays, allowing the client to complete the study on time.
- Under Budget: The client not only avoided additional costs but also managed to complete the trial under budget, further highlighting the value of the ISS Nexus solution.
Conclusion: ISS Nexus—A Strategic Partner in Trial Management
This case highlights the strategic value of ISS Nexus in managing the complexities of clinical trials. By providing real-time scenario analysis and rapid supply plan optimization, ISS Nexus enabled the client to navigate a potentially costly challenge with confidence and efficiency.
In the ever-changing landscape of clinical research, having a partner like ISS and a platform as robust as ISS Nexus can make all the difference. Through this experience, the client not only achieved their immediate goals but also set a precedent for how to handle future challenges. The trial was completed on time, under budget, and without the need for additional manufacturing—thanks to the power of ISS Nexus.