Expediting clinical trials with a global transportation footprint and clinical packaging

Clinical trials are increasingly global and include both traditional structures and newer site-free models with direct-to- and direct-from-patient delivery capabilities, reports Gulam Jaffer, President at Yourway

Sponsor companies and trial managers need the support of clinical logistics service providers that can do more than pick up and deliver biologic samples and clinical trial materials. With its global transportation footprint and clinical packaging services, Yourway allows trials to run more smoothly, efficiently and cost-effectively.

The Yourway depot network

To support international clinical trials, Yourway has invested in a global depot network that currently comprises 21 locations in the US, Canada, Mexico, UK, Ukraine, Belarus, Russia, Colombia, Peru, Chile, Panama, Brazil, Israel, South Africa, India, China, Australia, Hong Kong and Japan.

All of these facilities are GMP-compliant and include both ambient and cold chain pallet and shelf locations, as well as secondary packaging capabilities. They also have designated receiving and shipping and pick-and-pack areas; the return and destruction of unused clinical trial materials can also be managed at all of our depots — and all participate in the company’s centralised web-based reporting system.

Global transportation scope

Yourway was originally founded to rapidly deliver donor organs to transplant patients. During the last 20 years, we have grown from this original business, constructing a platform to manage the shipment of clinical trial materials to and from anywhere in the world.

With our biological, warehousing and logistical expertise and capabilities, and extensive network, Yourway provides the same-day or next-day delivery of shipments — even for specialty materials — with no size or weight restrictions.

Our couriers pick up shipments 24 hours a day, seven days a week — with no cut-off times and no hidden or express fees. We place deliveries on the first available flight using only premium flights, regardless of when orders are received. Yourway’s temperature-controlled transport specialists enable the shipment of Phase I, II, III and IV materials, finished goods and raw materials for production, including those for cell and gene therapies.

Worldwide customs preclearance capabilities proactively expedite delivery, so that Yourway can immediately clear and deliver shipments to their destinations. Yourway’s worldwide service also includes documentation support and the provision of regulatory advice regarding country specific requirements. Our proactive management approach helps our customers to avoid delays of all kinds during the shipment of critical clinical trial materials.

In addition to more traditional deliveries to investigator sites, Yourway has the capability to provide site-to-patient shipments in support of trials for personalised medicines. We can also develop customised delivery solutions if patients are travelling or moving to a new location — this makes it possible to keep all patients enrolled and receiving their medications in spite of an address change.

Once a trial is completed, Yourway can help to manage any reverse logistics requirements, including reclamation and value recovery, returns, reconciliation and storage, consolidation and, when appropriate, destruction or disposal.

Through our central, web-based portal, clients can track all types of shipments and receive automated notifications. Using this system, clients are given access to all the information about their shipments at any point in time throughout the course of transport.

Clinical packaging support

In addition to global transport capabilities, Yourway offers primary and secondary clinical packaging and storage/distribution services, providing added value to our clients. Arranging packaging, storage and shipping services within one organisation allows our clients to significantly reduce their lead times.

Primary packaging capabilities include bottling, blistering and over-encapsulation capabilities. Secondary services range from kitting, labelling and delabelling to blinding of placebos for clinical trials — we are also happy to work with clients on additional requests. Secondary packaging activities can be performed under ambient conditions or in a cold room or freezer, as required.

Packaged materials can be stored in Yourway’s GMP warehouses. Alternatively, they can be transferred in bulk to other depots immediately upon completion of the packaging run.

Each project is supported by a team of experts that provides planning, packaging design and preparation for a comprehensive supply chain solution, including the necessary components, packaging materials, labels and other requirements.

Throughout the process, customers have 24/7 access to trial information through our online management tool, which records the project steps, batch records, product inventory levels and product information (including locations, quantities, temperatures, etc.) in real-time.

Seamless operations

With effective project management teams and online monitoring and tracking solutions, Yourway ensures a seamless process from packaging to storage, distribution and delivery. Our customers have global access to a wealth of experts, systems and proven processes for ongoing and real-time support, and the assurance of a high-quality, high-throughput supply chain.

In addition, the integration of our multiple services simplifies project management for Yourway’s clients. Customers that outsource their clinical packaging and material warehousing, inventory management, distribution and transport to Yourway gain access to a wealth of strategic locations around the globe and advanced management technology without the issue of in-house oversight.

With all logistics needs for clinical trials easily obtained in one place, outsourcing to or managing relationships with multiple organisations is no longer necessary. We can source comparator drugs and other supplies, establish optimum delivery strategies across global trials and help to close-out studies by returning unused materials.

Adding value with bespoke solutions

Yourway does much more than provide clinical packaging and logistics services; we take a solutions management approach to customer service, working closely with our clients to provide a tailored plan for packaging, warehousing and transport that affords the maximum control of supply, speed and flexibility.

In addition to biologic samples and clinical trial materials, we are familiar with dangerous goods, controlled drugs, sample collection kits, ancillary products, medical equipment and other materials.

Customers that partner with us benefit from an array of solution-based offerings, including project management support, planning and optimisation guidance, comparator sourcing, ancillary supply sourcing, forecasting, returns/reconciliation management and regulatory support, among others.

Yourway has extensive experience developing and executing strategic solutions that ensure the management and delivery of clinical trial materials within relevant time constraints to required locations, even for challenging products such as patient-specific medicines.

We maximise the use of supplies and minimise waste and shipping costs while ensuring that products stay within specifications (temperature, pressure, etc.), creating efficient solutions for even the most complex supply chains.

We guarantee speed of delivery with highly customised transport solutions and work with each client and every shipment on a one-to-one basis to ensure the highest level of service. Our goal is always to ensure the fastest, most secure and most reliable delivery possible, which we have an impeccable record of achieving.

This content was originally published in Pharma’s Almanac and is reproduced with kind permission.

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