World Courier Management - An evolution of innovation

Smooth, reliable and efficient logistics are vital for keeping the clinical trial supply chain well oiled. With plenty of experience to draw upon, World Courier Management shares the conditions that need to be met to ensure that only the best supply strategy is pursued.

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) manufacturing, 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, clinical research is increasingly a global proposition that requires a departure from traditional supply strategies; and second, supply-chain flexibility is more essential now than ever before.

With manufacturers reining in costs worldwide, supply-chain innovation is essential to maximising investments. JIT tactics - such as pooling agnostic supplies and JIT labelling - work with multilingual labelling, interactive response technologies (IRT) and multistudy packaging to generate greater efficiency. 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 a depot network is often more difficult than it appears. Obviously, depot locations affect transportation costs, but a host of other factors can also influence quality, security and supply integrity - all of which can impact on the bottom line. World Courier Management has assembled a series of considerations that shippers can bear in mind when evaluating depot options for global clinical studies.

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 robustly. Look for ISO 9001-certified services.
  • Local expertise: choose depots where local staff members have knowledge of the specific environment
    and regulatory requirements, and can liaise with agencies in their own languages and time zones to speed up processes and enhance understanding.
  • Technology that delivers value: choose an offering with a refined inventory-management system, allowing real-time view of all 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 optimisation, 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 instils confidence: facilities should have restricted access, and automated alarm and monitoring systems. Multiple remote back-up systems, telephone alarms, light display and sound alarms are ideal to ensure the set temperature range is maintained. 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. Consider dedicated project-management support and depot rationalisation.

Accessing the clinical trial marketplace and taking into account growth in emerging markets, the industry is presented with challenges and opportunities alike, from evolving regulations, the rise of multinational logistics services, temperature-control innovation and the direct-to-patient model for supply. Optimising the supply chain, enhancing clinical-trial efficiency and selecting the right partners are critical steps for manufacturers in an increasingly cost-conscious and results-driven environment.

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World Courier Management

World Courier Management offers temperature-controlled transport systems ideal for the pharmaceutical supply chain.
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