Clinical Trial Supply & Logistics

Keep your trial organized and on schedule

Clinical trials pose numerous logistical challenges. A trial can’t run if drugs get stalled in cross-border customs, if there aren’t enough ancillary supplies to serve numerous patients, or if patient samples are damaged due to poor storage and shipping. When there’s so much at stake, you can’t afford to make mistakes.

At Parexel, we help you develop a supply chain management strategy that reflects the specific needs of your protocols and your patients. Unlike many supply chain logistics providers, we understand how clinical trials work. We’ll follow your drug through every stage of the trial process, from its first journey to investigator sites to disposal once the trial is complete. Our mission is to ensure clinical trial patients receive the right treatment, on time, every time, and safely.

Whether you are conducting a small regional project or a complex global trial, you need a robust supply chain network that includes country-specific knowledge and a close connection to local authorities. We provide the knowledge, systems, and connections for end-to-end clinical trial supply chain management.

From your first protocol designs onward, we’ll support you with a fully staffed team of clinical trial supply and logistics professionals who are ready to answer questions and meet challenges every step of the way. Our team includes:

• Import-export compliance specialists who plan licenses and navigate customs
• Quality experts who ensure that the product is safe
• Distribution center support staff who handle labeling, shipping, packaging, and storage
• Product specialists who use leading-edge technologies to monitor the drug throughout its life cycle

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Our hub-and-spoke network of distribution centers allows for global coverage

We can reach every corner of the world through a network of supply chain distribution centers, or depots. With three major hubs located in Pennsylvania, Berlin, and Singapore, as well as smaller spokes in South America and China, we can ensure that clinical trial supplies, ancillary supplies, and central lab services are delivered on time and within budget.

• Our owned network of clinical trial distribution centers can:
• Provide local or central sourcing of comparator and non-investigational medicinal products
• Coordinate investigational medicinal products manufacturing through our contract manufacturing organization partners or sponsor-delegated partners to optimize material utilization, supply and re-supply strategies, expiration dates, and costs
• Offer full-service and secondary clinical packaging for randomized, double-blind, or two/three-panel studies, as well as customized packaging design, customized secondary packaging, and patient supply kits
• Develop, translate, and distribute all the documentation for sites, investigators, or patients
• Receive, handle, and distribute IMP and ancillaries according to GMP regulation

Manage ancillary supplies with our clinical logistics leader

Clinical trials require a host of ancillary supplies, including medical equipment, centrifuges, disposable products, case report forms (CRFs), and investigator literature. It can be challenging to ensure that essential supplies reach trial sites in a cost-efficient manner.

We consolidate as many non-drug related outbound activities as possible. Our clinical logistics leader provides centralized management of all ancillary materials and serves as the focal point for the coordination in the critical CTM supply chain so that supplies arrive right where they need to be.

We provide:

• Accurate supply forecasts, as well as sophisticated reporting on expiry dates and shipment status
• Consolidation of purchasing, storage, assembly, and transportation processes, saving sponsors time and money
• Country-by-country knowledge of import/export rules, avoiding complications such as bans on certain diagnostic and testing equipment

Achieve global trade compliance with a multinational team of experts

At Parexel, our international clinical supply team diligently works hard to maximize efficiencies and ensure that investigational products and study supplies are packaged and labeled correctly and arrive at trial sites on time.

Our team is strategically located in countries that allow international management and direct engagement with customs and other government authorities. On top of that, we can act as the importer in all countries allowed by the legal and regulatory framework. We take pride in providing you with the best in-line import and export services, because we know you rely on us to have up-to-date knowledge of global trade compliance requirements, ensuring first-time clearance for shipments.

Our dedicated team consists of quality management, operational excellence, and industry consulting groups that can:

• Ensure shipment is customs compliant
• Make all necessary customs and additional agency declarations
• Make payment for the duties and taxes
• Follow up with the government authorities regarding the status of imported goods
• Apply for import/export permits

Lifecycle management that makes life easier

When volunteers are generous enough to provide biological samples for a study, we don’t take that for granted. In fact, without them, it would be nearly impossible to successfully develop new medicines at all. Our laboratory logistics team works with you to understand the specific demands of your project, then creates a tailor-made strategy that works hand-in-hand with all regulatory requirements across your supply chain.

At every turn, we develop common-sense shipping solutions. We do this by consolidating certain study-related lab and ancillary supplies to reduce the overall number of shipments, costs, and ultimately our carbon footprint.

With integrated locations worldwide, our approach is flexible and scalable. So no matter where you hail from, your samples can get where they’re needed.

We can help with:

• Improved inventory control for all types of human biological samples starting at time of collection
• Accelerated study start-up and closure with synchronized data/sample reconciliation
• Reduced costs through consolidated site supply and sample transport
• Improved regulatory compliance by real-time tracking of samples and ICF checks
• Optimized sample use and lower biobanking costs via reduced R&D cycle times and increased future-use of samples