Partnering With Your Teams To Enhance And Increase Supply Chain Efficiency

The Challenge: Limited Resources
An emerging biopharmaceutical company was working on multiple studies when they experienced a significant amount of staff turnover within their clinical supply department. Left with just one Clinical Supply Manager and four global Phase III trials to initiate and execute, the company was faced not only with a lack of bandwidth but limited global organizational experience by which to develop and execute a supply chain strategy for one, much less four, clinical trials.

The Solution: Clinical Supply Optimization
Having had prior experience with Fisher Clinical Services, the company’s leadership reached out to engage the Fisher Clinical Services’ Clinical Supply Optimization team in order to stay on track with timelines and ensure funding milestones were met.

The Experience: Access to Clinical Research Leadership
The portfolio of trials was assigned to a Senior Clinical Supply Chain Manager, with over 20 years experience working in the industry for both small and large pharmaceutical companies. She served as the primary point of contact for the company and CRO, and worked with an internal team of Fisher Clinical Services project managers across the supply chain to ensure seamless end-to-end execution for each trial. Additionally, she, supported by this team of experts, was able to:

• Provide proactive recommendations on the clinical supply chain strategy across all clinical trials and geographic regions
• Forecast initial and ongoing drug demand and patient enrollment to mitigate drug wastage, confirm and fine tune manufacturing schedules as needed, and effectively manage inventory against expiry
• Coordinate the startup of multiple studies and longterm extension, all simultaneously, while working with both the company and the CRO involved
• Work with the IRT vendor, in addition to the CRO, performing UAT for any supply chain functionalities, and recommend automated initial and resupply strategies
• Develop and execute a labeling strategy that required development of the English master label text, all necessary translations and label production of over 45-page global booklet labels for over 30 countries
• Forecast and refine distribution strategies to reduce costs
• Work with the Account Executive to revise quotes to accurately reflect supply plan and strategies

Often times, CRO’s are not aware of the intricacies necessary to effectively develop and execute global clinical supply chains in support of overarching clinical timelines. For example, they can often be surprised by the difficulty of moving drugs into certain countries or how long it may take to move drug through customs. By utilizing the PM toolkit, the Senior Supply Chain Manager was able to facilitate communication between the CRO, Fisher Clinical Services and the pharmaceutical company as well as ensuring accurate global study timelines were established and met. In addition, the Fisher Clinical Services Supply Chain Manager created an Excel forecasting template for the CRO to estimate patient enrollment on a month by month basis. This allowed the CRO to provide estimated enrollment information and gave them the resources to work together with the Clinical Supplies Optimization team to provide an accurate picture of the clinical trial supply demand.

The Results: A Streamlined, Efficient Clinical Supply Chain
With the support and expertise of the Senior Supply Chain Manager, the company was able to accomplish the following across all four studies:

• On time completion of UAT
• First packaging campaign completed on time
• On track to release the product on time
• First shipment on track to meet anticipated First Subject In (FSI)

After trial execution, the company determined that the level of support they received far exceeded their financial ability to add those resources as head count to their own organization. Fisher Clinical Services Clinical Supply Optimization is now an extension of the company itself, helping to manage all its clinical supply needs. Indeed, Fisher Clinical Services provides the expertise of a big company with a local, hands-on feel to every trial, regardless of size or phase.