As the pressure to get drugs to market faster increases, sponsor companies are continually evaluating ways on how to clinical trials efficiently. A key aspect of achieving these efficiencies is the effective transformation of the clinical supply chain and its associated processes. Supply Chain Management (SCM) needs a digital and physical solution that is both integrated and seamless.
When operating in today’s complex digital and physical environment, there are three fundamental capabilities that biopharma companies need to improve upon to maintain and enhance their SCM performance:
• Visibility. Better visibility helps the SCM team set priorities and ensure resources are allocated in line with the priorities. It can also smooth the transition from research to manufacturing and commercialization.
• Traceability. Better traceability improves the organization’s SCM ability to maintain compliance and address regulatory requirements. It also enables improved use of knowledge assets by allowing product development teams to retrace development decisions made in the past.
• Collaboration. It involves the SCM team partnering with many different organizations. Better collaboration enables a richer understanding of global challenges and creates more SCM solutions.
When examining ways to improve clinical SCM, there are several facets that need to be considered. They are: Business Intelligence collection, Reaching for Commercial Excellence, Pricing and Contracting for SCM, Quality and Compliance, Coordination among R&D / MFG, Practices in assuring Supply Chain Integrity with effective Supply Chain Planning, Product Lifecycle Management (PLM), Supply Chain Collaboration, SCM Systems & Strategy, and Risk Mitigation.
Within every sponsor company, the SCM team is responsible for coordinating:
- Packaging design
- SCM Contingency planning
- Distribution strategy and management
- QP release
- Commercial drug procurement
- Master label text generation and translation
On FORECASTING, SCM team is to follow:
- Protocol design impact on clinical supplies
- Scenario planning
- Review Forecasting vs. Actual drug usage
On SUPPLY CHAIN OVERSIGHT, SCM team is responsible for:
- Manufacturing and production planning
- Global inventory management
- Expiry and re-test management
- Identifying trends and adjusting plans to optimize supply chain
On DISTRIBUTION MANAGEMENT, the SCM team is to perform on:
- Shipment quantity optimization
- Temperature surveillance – end-to-end management
- Global depot network management
Many companies are now recognizing the potential benefits of having a more holistic approach to clinical supplies as it affords the SCM team the ability to monitor supply activities across multiple trials worldwide. Additionally, an all encompassing approach provides a platform to standardize processes while making supply management processes more streamlined.
For efficient delivery of supplies, the SCM team and contractors must have an established transportation and storage infrastructure that includes vetted third-party freight carriers and storage facilities. With solid knowledge of shipping options and current regulatory requirements, they determine the optimal distribution logistics. Key considerations you need to factor are:
- What are the most effective routes of transportation?
- Who are the most efficient, reliable freight couriers?
- Which freight courier is best for a particular shipment?
- What is the best way to coordinate shipping schedules and manage requirements for air, ocean, and ground transit?
- Which port of entry has the most efficient government customs clearance process?
- What special arrangements must be made for time-and temperature-sensitive supplies?
- Distribution managers should also be knowledgeable about the unique regulatory requirements of each country.
Additionally, when it comes to self evaluation, the SCM team must answer the following questions:
- Do we have tools to connect people and processes, enabling informed decisions for the utmost confidence in the broader supply chain?
- Are we able to make purchasing choices based on an optimized global plan?
- Do we combine demand forecasts with a manufacturing bill of materials, processes, efficiency goals and timelines to determine the manufacturing and packaging plan at all material levels?
- Do we have web-accessible tools for SCM?
- Can we forecast the supply chain across ALL STUDIES to any level you desire, from Finished Goods to API?
- Do we know how much drug to manufacture, package, and/or purchase?
- Do we have an established collaborative environment that makes it easy to share plans with peers, partners, customers and management?
- Can we forecast supply needs, run simulations, and develop a comprehensive plan with our input?
- As a study progresses, can our team revisit forecasts using the latest actuals as well as alert ourselves of changes and potential complications?
- Do we have solutions to enhance and supplement our core manufacturing, packaging and distribution services for investigational products?
Planning and managing clinical trials is an increasingly complex task. Unlike standard supply chains, there are many unpredictable factors within clinical material supply chain management. The SCM team needs to reach excellence in clinical supply chain management to maximize operational effectiveness. Achieving excellence and effectiveness will in turn save a company millions of dollars in R&D costs.