Featured Viewpoint: Clinical Logistics Services

By: Jens Mattuschka
Director Clinical Logistics, Worldwide

Leveraging clinical logistics to improve trial efficiency

Taking a coordinated approach to clinical logistics services ensures that the right supplies reach the right locations at the right time in the right condition – reducing costs and avoiding trial delays.

In today’s competitive biopharmaceutical environment, no one can afford delays in critical trial milestones because of problems with clinical supplies and logistics.  As trials become more global and complex, however, sponsors are finding it increasingly difficult to arrange reliable delivery of trial related supplies to multiple locations around the world.  One recent survey reported that only 23 percent of sponsors rated their clinical supply chain as effective, and just 13 percent said their clinical supplies usually arrive on time and complete.

With the economic pressures on biopharmaceutical companies to improve trial performance while reducing overhead costs, many sponsors are turning to outside companies for comprehensive clinical logistics services (CLS).  A typical CLS partner would provide centralized coordination of all clinical trial supplies and logistics, related inventory data management services, and quality monitoring, as well as overseeing subcontracting relationships such as lab services and couriers.  

The two major components of clinical logistics are:

• Clinical Supply Chain Management, including:
  • Clinical Trial Supplies – Coordinating drug supply from wholesalers, manufacturers, managing import/export requirements, labeling, warehousing and inventory control, distribution of drug supply to trial sites, and return and destruction of unused medication.
  • Ancillary Supplies – Coordinating purchasing, distributing testing and diagnostic equipment, maintaining lab supplies, and providing CRFs, investigator brochures and other site documents, and return, recycling or destruction of unused materials. 
• Lab Services, including selection of analytical laboratories, organizing a centralized lab system/process, supplying forms and kits for patient visits, overseeing transportation logistics for lab samples, and managing/cleaning lab results.

A centralized approach to CLS eliminates costly delays by closely coordinating all three components and integrating them into the overall clinical trial process.  The key for sponsors is to find a CLS partner with the knowledge and experience to effectively manage worldwide clinical trial logistics, as well as the required depth of resources, including a global distribution infrastructure, local expertise in import/export regulations, and sophisticated technology systems.  In short, a sponsor’s CLS partner must be able to deliver the right products to the right locations at the right time – an accomplishment that will help accelerate site readiness, improve lead times, reduce study costs and increase compliance.

Efficiently managing clinical trial supplies
With the high cost and stringent handling requirements for many biopharmaceutical products, clinical supply logistics are more critical than ever.  The value of some study drugs can reach tens of millions of dollars, so it is essential to avoid overproduction, oversupply, and inventory expiration issues.  

The key functions for managing clinical trial supplies include:

• Developing cost-efficient clinical supply strategies and forecasts, supported by sophisticated computer simulations
• Ensuring that appropriate import/export requirements are met
• Actively managing the labeling process for drug supplies
• Managing GMP vendors
• Providing investigators and depot partners with documents to support staff training 
• Defining, executing and controlling a suitable drug storage and distribution system
• Closely monitoring supply couriers to maintain schedules and performance 
• Day-to-day monitoring of inventory stocks along the entire supply chain – from the manufacturers to local depots and investigational sites
• Continually evaluating logistics and supply data to strengthen and refine strategies
• Ensuring a suitable return and destruction system, including managing the collection of all relevant documentation to minimize patient and sponsor risks.

Trial supply functions require specialized knowledge and infrastructure that may not be available from typical GMP or drug distribution providers – especially when trials include hundreds of sites in multiple countries.  An experienced CLS partner can help ensure regulatory compliance for far-flung logistics activities, as well as implement integrated global solutions that support consistent, high-quality processes across all trial sites.  For multinational trials, global regulatory experience is also vital.

Improving supply forecasts
Forecasting is one of the most important aspects of effectively managing clinical supplies.  Sophisticated simulations are essential to provide answers for key study supply questions, such as:

• What quantity of supplies does the study require?
• What are optimal dispensing unit/kit sizes?
• What lead times are expected for local importation, and what is the implication for patient recruitment?
• What if recruitment is faster or slower than anticipated?
• What is the impact of initiating additional sites, or opening sites in additional countries?
• When should additional production runs be scheduled?
• How do medication expiry dates affect the study schedule?

Obtaining the right answers to these questions can substantially reduce expenditures for a sponsor by avoiding overproduction, overstocking and supply shortages.  As many as 30 variables might have to be considered, weighing factors such as drug cost, number of patients, number of sites, recruitment curves, number of depots, product expiration dates, and the size of production batches.  Given this multiplicity of variables, robust forecasting and simulation software – plus experience in using the software in complex trials – is required to achieve the appropriate balance of total drugs needed, stock levels per depot, and shipment frequency for each study.

Coordinating ancillary supplies
Ancillary supplies are an important element of clinical supply chain management.  Clinical trials require a wide variety of ancillary supplies, such as diagnostic and testing equipment, medical devices, refrigerators, centrifuges, ECG machines, test strips, and disposable products, or even computer equipment such as instruction DVDs, CDs and tapes.  Every site must also be supplied with numerous trial documents, including site reference manuals, investigator brochures, paper CRFs, diaries and trial protocols.  The growing complexity of many trials has increased both the volume of these ancillary supplies and the number of vendors needed to produce them.

As a result, global trials require centralized management of all ancillary materials to ensure that essential supplies reach every site in a cost-efficient manner to save sponsors time and money.  By coordinating its efforts with clinical resources, a centralized ancillary supplies team can determine what supplies are needed for a specific trial, and then ensure that the required material reaches the sites to meet study timelines.  Transporting these supplies requires country-by-country knowledge of import/export rules, such as the fact that some countries ban the importation of certain diagnostic and testing equipment.

Key capabilities for efficient, centralized ancillary supply services include:

• Accurate supply forecasts
• Well-established material ordering processes
• Full inventory transparency, including location data – a critical feature for recall support
• System control and facilitation of manufacturing processes (e.g., kit assembly)
• Barcode usage for all relevant system applications
• Inventory and expiry-date management, including re-supplies
• Automatic, real-time proof of delivery 
• Sophisticated reporting on expiry dates and shipment status

Centralizing lab services
As clinical trials address increasingly complex diseases, the lab services required to process samples must be more sophisticated.  With biomarkers, genetic sampling, and other new types of testing becoming commonplace, selecting reliable lab resources and managing time-sensitive shipments between multiple sites and various specialized labs is a substantial logistical challenge.  

Sample analysis can represent as much as 80 percent of study data, making it critical to study success.  Providing reliable lab services and robust data requires meticulous planning of sample handling, transport, analysis and reporting.  Sponsors are increasingly turning to CLS providers that can centralize the provision of lab services and manage lab-service logistics.  

A qualified lab/logistics partner must provide safe and reliable handling of sample collection and shipments around the world, with services that typically include:

• A centralized network of highly qualified labs that have been pre-screened for ICH-GCP compliance, quality, data security, and reliability
• Lab vendor management, including performance and quality oversight
• Import/export management
• Delivery of kits and lab supplies to the trial sites
• Transportation and tracking of lab samples
• Data tracking and integration services 
• Real-time lab data cleaning and security
• Regulatory compliance

 
Integrated lab information systems and databases are also key success factors for centralized lab services.  A consolidated database that brings together paper CRF or eCRF and Lab Request Forms – as well as results and clinically relevant checks – improves accuracy, avoids duplicate data entry, clarifies the primary data source, and harmonizes query procedures.  The result is a reduction in the number of queries, avoidance of late-stage data issues, and faster database lock.

Meeting the logistics challenges of today – and tomorrow

Complex global trials require centralized, end-to-end management of clinical logistics to reduce costs, improve compliance, and increase efficiency in every aspect of clinical trial supplies, ancillary supplies and lab services.  To meet that challenge, sponsors must select a CLS partner with global experience, integrated solutions, and a multinational infrastructure.  With the right partner, a sponsor can reduce total drug development costs, improve regulatory compliance, optimize the flow of costly study drugs, enhance data management, reduce overhead costs, and – most important – increase patients’ safety in every clinical trial.