Project Management for an In-House Clinical Inventory Management and Distribution System
Clarkston Consulting recently partnered with a client in the life sciences industry on an in-house clinical inventory management and distribution system. Read a synopsis of the project below or download the full case study.
Download the In-House Clinical Inventory Management and Distribution System Case Study Here
The client, a leading pharmaceutical and biotechnology company, has undergone a significant transformation, evolving from a research-stage organization focused on precision medicine into a diversified enterprise with a broad clinical portfolio of vaccines and therapeutics across several modalities. As the company grew, it encountered challenges in managing its clinical supply inventory, which was dispersed across various in-house systems, contract manufacturing organizations (CMOs), interactive response technology (IRT) systems, and site-managed systems. This fragmentation made it difficult to consolidate depot inventory and maintain visibility and flexibility between virtual and physical supply chains. The lack of a unified system hindered the clinical supply team’s ability to effectively rearrange shipments, posing risks to the efficiency and timeliness of clinical trials.
To overcome these challenges, the company required a digital platform that could provide centralized, end-to-end visibility of inventory by tracking the movement of supplies throughout the clinical supply chain—from manufacturing to central depots and sites. The system would manage clinical supply master data, packaging and labeling operations, drug orders, and shipments, while also tracking the chain of custody and chain of identity for drug products. Additionally, it would allow for drug pooling, enabling flexible and optimal drug allocation across multiple studies, thereby enhancing the efficiency and effectiveness of clinical supply management.
Recognizing that no off-the-shelf product could meet their specific needs, the company decided to develop a tailored in-house clinical inventory management and distribution system for their Clinical Supplies and Development Operations. Implementing standard Agile processes and Good Engineering Practices was essential for developing and delivering this custom-built GxP software solution. To ensure the success of this initiative, they engaged Clarkston’s project management experts to streamline the design, development, validation, and implementation processes within the GAMP5 framework, seamlessly integrating it with an Agile approach.
Download the In-House Clinical Inventory Management and Distribution System case study, and learn more about our Program & Project Management Consulting Services by contacting us below.
Contributions by Anjali Nagrecha
