New Requirements In Global Clinical Supply Spur Evolution and Innovation.
Who knew clinical trial logistics had so much in common with the automotive and high-tech industries? That certainly seems to be the case with trends like just-in-time (JIT), customer-managed inventory (CMI) and vendor-managed inventory (VMI). All of these initiatives came to the clinical trial logistics market as ideas proven in other, seemingly unrelated industries.
The growing prominence of these initiatives in the clinical trial market points to two key trends in pharmaceutical development: first, that clinical research is increasingly a global proposition that requires a departure from traditional supply strategies; and second, that supply chain flexibility is more essential today than ever.
With manufacturers reining in costs worldwide, supply chain innovation is essential to maximizing investments. Just-in-time tactics — such as pooling agnostic supplies and just-in-time labelling — work in concert with multi-language labelling, interactive response technologies (IRT) and multi-study packaging to generate greater efficiencies.
The use of clinical trial depots has risen in popularity as well, with shippers valuing the ability to import bulk quantities of materials with a single clearance. This results in reduced paperwork and lower transport costs. In some cases the use of a depot is required by local regulations.
Choosing the right depot network is often more difficult than it appears. Obviously, the depot locations affect transportation costs. But a host of other factors can influence quality, security and supply integrity-all of which can have a huge impact on the bottom line.
World Courier has assembled a series of considerations shippers can bear in mind when evaluating depot options for global clinical studies.
Supply Strategy Best Practices: What Should Depots Include?
- Certified, Verified Quality - Insist on GxP-compliant facilities and a suitable quality management system with comprehensive SOPs, processes and work instructions. Each location should have a quality assurance representative to manage client audits and ensure processes are carried out in a robust fashion. Look for ISO 9001-certified services.
- Local Expertise - Choose depots whose local staff members have knowledge of the specific environment and regulatory requirements, and can liaise with agencies in own language and time zones to speed up the processes and enhance understanding.
- Technology That Delivers Value - Choose an offering with a refined inventory management system, allowing real-time view of all inventory management transactions. This enables improved forecasting of manufacturing cycles and ensures traceable movement of all material received, stored and distributed. Select vendors that can offer investigative site optimization, leveraging technology solutions.
- Processes for Product Protection - Look for a single chain of custody from manufacturing site to trial site to simplify the risk management process and comply with anti-counterfeiting and falsified medicine regulations. Systems should be in place to separate kits and recalled drugs from active clinical supplies including investigational drugs and medical devices.
- Security That Instills Confidence - Facilities should have restricted access, automated alarm and monitoring systems. Multiple remote back-up systems, telephone alarm, light display and sound alarm are ideal to ensure the temperature is maintained within the set range. Redundant systems of temperature detection data loggers with memory and graphic display for each temperature can provide peace of mind.
- Solutions Tailored to Individual Needs and Budgets - Request flexible packaging solutions based on IMP requirements for time and temperature to streamline validation and prequalification. Think about depot rationalization, dedicated project management support.