Request: A leading biotech client approached CSI to assist in sourcing the comparator drug Lucentis for a Phase II ophthalmology clinical trial. The study required precise planning and timely execution to ensure uninterrupted supply across multiple global sites. The client prioritized batch consistency and Certificates of Analysis (CoA) for all supplies.
Challenge: The biotech faced several hurdles in sourcing Lucentis; being a high-demand ophthalmology drug, there was limited availability in the required markets. Additionally, the client required detailed Certificates of Analysis (CoA) for each batch to ensure quality and to ensure that the sourced drug met regulatory requirements across different countries
To make matters more complex, the client required a single batch to maintain uniformity and avoid variability in trial results. The study had stringent timelines, leaving no room for delays in procurement or delivery.
Solution: CSI leveraged its expertise and global network to address the client’s needs. Utilizing CSI’s established relationships with manufacturers and distributors, the team secured sufficient quantities of Lucentis, considering multiple purchases throughout the study according to the shelf life of the product.
The sourcing strategy also focused on regions with regulatory alignment to the study’s requirements and through careful planning, CSI sourced Lucentis from the same production lots whenever possible, ensuring batch-to-batch consistency.
CSI implemented a robust logistics plan, to minimize lead times and ensure on-time delivery to all global trial sites.
Outcome: The client’s Phase II ophthalmology study proceeded without delays or supply interruptions. By securing Lucentis with complete CoA documentation and maintaining compliance, CSI ensured the trial’s integrity and accelerated the approval process. The client acknowledged CSI’s contribution as instrumental in meeting their ambitious timelines and achieving study milestones.
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