Industry Perspective:
Q&A: Clinical Logistics Services

What is driving the trend to outsource Clinical Logistics activities?

The major driving force in clinical logistics is the globalization of clinical studies.  This trend has been fueled by several factors, including the need to access larger patient populations that will accommodate expanded trials and accelerate patient recruiting.  Globalization is also driven by the pressure on biopharmaceutical companies to reduce trial costs, which can be accomplished by taking advantage of high-quality, lower-cost clinical resources available outside North America and Western Europe.  More than 20 percent of all clinical trials are currently being conducted in emerging regions such as Latin America, Central and Eastern Europe, and Asia, and that percentage is increasing rapidly.

While globalization offers many benefits for trial sponsors, it also creates significant logistical challenges.  Effective management of the clinical supply chain for large, multinational trials requires centralized coordination and country-specific knowledge – plus a significant commitment of resources – to maintain reliable deliveries and avoid costly delays.  Those resources include:

• A suitable supply chain network that encompasses wholesalers and manufacturers, as well as a distribution and warehousing infrastructure that can properly handle and transport expensive drug supplies and the many other necessary clinical trial materials (e.g. lab kits, test devices and medical equipment) to locations across the globe.
• Expertise in import/export regulations for each country.
• Sophisticated technology systems to forecast demand, track and monitor shipments and inventories.
• The experience and expertise to coordinate complex, multinational logistics.

Most biopharmaceutical companies do not have the full range of internal resources to handle this broad array of requirements on a global basis.  Also, the traditional GMP providers, lab service suppliers, printing companies and courier providers that have partnered with biopharmaceutical companies in the past do not offer this full spectrum of services, expertise and infrastructure needed to accommodate the requirements of today’s global trials.  As a result, biopharmaceutical companies are increasingly relying on clinical logistics service partners that can meet their complete clinical supply chain requirements.  This approach allows sponsors and sites to devote their resources to patients  and other critical trial issues, and spend less time worrying about supplies and logistics.

What are the key benefits offered by full-service clinical logistics providers?

By selecting the right partner, trial sponsors can enjoy significant benefits in every aspect of their logistical challenges, including:

• Process improvement – Improved flow and handling of all trial-related supplies, using a centralized, coordinated approach that is integrated into the trial process, supported by the implementation of proven procedures that are replicated at all trial sites.
• Improved regulatory compliance – An experienced global provider can help sponsors navigate the constantly-changing, country-specific guidelines covering the import and export of drugs, as well as other clinical trial materials and biological samples, to avoid regulatory delays.
• Access to specialized technology – Sophisticated forecasting and supply systems to accurately predict production and inventory requirements, track shipments, coordinate the transportation and speed up data query resolution.
• Cost reduction/cost avoidance – A clinical logistics partner can help sponsors reduce the need for costly infrastructure investments, increase efficiency through economies of scale, and reduce supply costs by avoiding overproduction, oversupply, and expiration issues.
• Risk reduction – Centralized coordination of the entire clinical supply chain decreases a sponsor’s risk of project failure by improving the reliability of every aspect of clinical supplies to support patient safety, avoid costly trial delays, increase data accuracy, and reducing budget overspending.

What is the role of a Clinical Logistics Leader?  Why is this function important for the success of multinational trial logistics?

One of the most effective ways to create a strong, efficient clinical logistics system is to have a leadership position in place to specifically oversee and coordinate the clinical supply chain – a position that has come to be known as a “clinical logistics leader.”  In the past, the biopharmaceutical industry – including CROs, CMOs and Central Lab providers – typically assigned managers for each specific area of a trial, such as clinical operations and data management, as well as logistics businesses such as wholesaling, manufacturing, distribution of study drugs, purchasing of other trial materials, and lab services.  However, providers have not put the clinical supply chain under one umbrella. With the growing importance of global logistics, it is vital to establish a leadership position focused directly on this area.

A clinical logistics leader can play a crucial role in the drive to greater logistics efficiency by coordinating and integrating processes along the entire supply chain, and ensuring that the right resources, technology, and expertise are applied to the full spectrum of clinical logistics services.

What do clinical logistics leaders do?  It is their responsibility to oversee all aspects of the clinical supply chain, including:

• Define and deploy a clinical logistics strategy in concert with a sponsor and other relevant stakeholders for drug supplies, ancillary supplies and central lab services.
• Take an active liaison role between clinical managers, the sponsor, and third parties involved in supplying materials throughout the study lifecycle.
• Manage the overall logistics plan and resources in a coordinated fashion to maximize the efficiency of wholesaling, manufacturing, printing, central and local clinical trial material storage, shipping, and central and local laboratories.
• Leverage appropriate technology solutions to improve efficiency and maintain quality.
• Maintain overall cost control in order to maximize cost savings along the clinical supply chain.

A clinical logistics leader also ensures that logistical planning is integrated into the trial process from study start-up planning, so the supply system will mesh seamlessly with trial requirements and timelines.  

The use of a clinical logistics leader to oversee the clinical supply chain will accelerate site readiness, minimize supply and distribution issues, and reduce the risk of delays – improvements that will save time and money, and – most important – increase patients’ safety.