Case Study: Sourcing Lucentis for a Phase II Ophthalmology Clinical Trial

A Leading Biotech Client's Challenge

A leading biotech client approached CSI to assist in sourcing the comparator drug Lucentis for a Phase II ophthalmology clinical trial. This project demanded precise planning and timely execution. It was crucial to ensure an uninterrupted supply across multiple global sites. The client prioritized batch consistency and Certificates of Analysis (CoA) for all supplies.

Understanding the Challenges

The biotech company faced several hurdles in sourcing Lucentis. Being a high-demand ophthalmology drug, there was limited availability in the required markets. This scarcity made it challenging to find adequate supplies. Moreover, the client needed detailed Certificates of Analysis (CoA) for each batch. This was essential to guarantee the quality of the drug and meet regulatory requirements across different countries.

To make matters more complex, the client required a single batch to maintain uniformity throughout the study and avoid variability in trial results. The study also had stringent timelines, which left no room for delays in procurement or delivery.

Developing the Perfect Solution

Leveraging Expertise and Network

CSI leveraged its expertise and global network to address the client’s needs effectively. By utilizing established relationships with manufacturers and distributors, the team managed to secure sufficient quantities of Lucentis. This strategy considered multiple purchases throughout the study, taking into account the shelf life of the product.

Additionally, the sourcing strategy concentrated on regions with regulatory alignment to the study’s requirements. Through careful planning, CSI sourced Lucentis from the same production lots whenever possible. This approach ensured batch-to-batch consistency, a critical element for clinical trials.

Implementing Robust Logistics

CSI also implemented a robust logistics plan to minimize lead times. This logistical strategy was vital to ensure on-time delivery to all global trial sites. The planning process involved thorough coordination with suppliers and logistics partners. By doing so, CSI aimed to finalize its supply chain efficiently.

Successful Outcome

Meeting Regulatory Standards

As a result of these combined efforts, the client’s Phase II ophthalmology study proceeded without any delays or supply interruptions. By securing Lucentis with complete CoA documentation and maintaining compliance, CSI ensured the trial’s integrity. This, in turn, helped accelerate the approval process.

The client acknowledged that CSI’s contribution was instrumental in meeting their ambitious timelines and achieving study milestones. This successful collaboration not only improved the supply chain's efficiency but also reinforced CSI's position as a trusted partner in the biotech field.

Key Takeaways

1. Precision in Planning: The importance of thorough planning and precise execution cannot be overstated, especially in clinical trials.

   
   

2. Sourcing Challenges: Understanding the complexities of drug sourcing is essential for successful clinical trial management.

   
   

3. Logistics Matter: A robust logistics strategy is crucial for ensuring timely delivery and avoiding interruptions in supply.

   
   

4. Regulatory Compliance: Maintaining regulatory standards through proper documentation is vital for the integrity and success of clinical trials.

   
   

By focusing on these key areas, CSI effectively navigated the challenges posed by sourcing Lucentis and ensured the successful execution of the Phase II clinical trial. This collaboration highlighted the importance of strong partnerships and strategic planning in achieving clinical research goals.

To learn more about achieving successful clinical trials and sourcing solutions, check out CSI's services.