A large, global pharmaceutical company selected Marken as a key supplier and partner for their clinical division, which included moving 25 ongoing clinical studies from their current Smart Hub to Marken’s GMP-compliant Smart Hub located in Moscow, Russia. The scope of this project involved moving the temperature sensitive products, which ranged from 2 to 8⁰C and 15 to 25⁰C, within a short three-month timeframe and ensure no disruption to the current studies or patients.
The temperature sensitive products required strict timelines to allow for immediate receipt and distribution to clinical sites to ensure patients received their clinical drugs on time.
Careful planning, coordination and communication took place along each step between the client and Marken to maximize the logistical steps needed for a successful operation.
Marken’s CTD Smart Hub Head and Technical Director in Moscow served as the main point of contact for the client and supervised the overall transfer process. Marken’s Moscow Smart Hub team and the client developed a step-by-step Transfer Plan and contingency strategies. The Marken logistics plan coordinated relevant Transport and Packaging Configurations (TPCs), cooling components and temperature measuring devices.
The Transfer Plan outlined the responsibilities of each party and provided a detailed guidance of transfer activities to ensure a smooth and secure process including close coordination with the incumbent Smart Hub provider before and during the transfer for complete visibility and compliance. All data was provided in advance including MSDS, import license, Ministry of Health (MoH) approval and elaborated study manuals.
Roles and Responsibilities:
- Marken CTD Smart Hub Head and Technical Director – Managed the overall transfer process and ensured the temperature conditions of transferred material was met. Provided data reports to the client and confirmed supplies were placed within relevant controlled temperature regiments
- Marken CTD Project Manager – Communicate the transfer requirements, timelines and moving days with client counterparts
- Marken CTD QA – Assess documents and products with regard to global and local requirements
- Client – Approved the plan and provided material handling guidelines in advance of the transfer process. The client also provided the final release of the material received at the Marken Smart Hub
Marken utilized temperature controlled vehicles (TCV) and Credo solutions to carefully move the product within temperature specifications and for optimal safety.
A key challenge to ensuring smooth operations for the ongoing studies was developing a technology transfer between the client and Marken. A robust technology control was established in the Transfer Plan for moving the product and immediate post-smart-hub distribution.
Marken’s Russian team successfully transitioned the ongoing clinical protocols with no disruption to the client’s operations. Each study was moved as scheduled in the Transfer Plan, and we met the three month timeline specified by the client.
Our team worked tirelessly with the client to develop the robust Transfer Plan and utilized our clinical trial expertise to implement the processes and procedures to maintain the integrity of the product.
The success of this project confirmed Marken as the most reliable and dynamic service provider in Russia, with the capability to store and distribute clinical trial product safely and securely, and has led to the award of similar complex projects within the region.
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