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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 prioritised batch consistency and Certificates of Analysis (CoA) for all supplies.
Challenge
The biotech client faced several hurdles in sourcing Lucentis for their study:
Lucentis, being a high-demand ophthalmology drug, had 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 across batches to 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.
Case Study
Comparator Sourcing for a Phase II Ophthalmology Study
A biotech client asked CSI to source Lucentis for a Phase II ophthalmology trial.
Request
The clinical trial proceeded without delays and the client acknowledged CSI’s contribution as instrumental in meeting their ambitious timelines
Challenge
Limited availability of high-demand drug Lucentis, need for batch consistency,
regulatory compliance, and strict timelines.
Solution
CSI leveraged its global network to secure Lucentis, prioritized regulatory-aligned sourcing, ensured batch consistency, and optimized logistics for timely delivery.
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