Expediting Clinical Trials with a Global Transportation Footprint and Clinical Packaging

Clinical trials are increasingly global and include both traditional structures and newer siteless models with direct-to- and direct-from-patient delivery capabilities. 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 U.S., 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 centralized web-based reporting system.

Global Transportation Scope

Yourway was originally founded to rapidly deliver donor organs to transplant patients. Over the last 20 years, we have grown from this original business, constructing a platform for managing the shipment of clinical trial materials to and from anywhere in the world. With our biological, warehousing and logistical expertise and capabilities supported by our extensive network, Yourway provides 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 production raw materials, including those for cell and gene therapies.

Worldwide customs pre-clearance 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 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 personalized medicines. We can also develop customized delivery solutions if patients are traveling 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 manage any reverse logistics requirements, including reclamation and value recovery, returns and reconciliation and storage, consolidation, destruction or disposal, when appropriate.

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 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 organization allows our clients to significantly reduce their lead times.

Primary packaging capabilities include bottling, blistering and over-encapsulation capabilities. Secondary services range from kitting, labeling and delabeling 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.

Providing the Full Gamut of Integrated Services

With our global transportation footprint and clinical packaging services, Yourway offers the unique combination of highly responsive, personalized logistics support and the full gamut of integrated services, enabling both traditional and hybrid/virtual trials to run more smoothly, efficiently and cost-effectively.

Yourway is the only truly integrated premium courier and clinical packager, offering — along with our comprehensive transport capabilities — primary and secondary pharmaceutical packaging services, warehousing and distribution support, including cold-chain solutions, unused product return services and assistance with logistics project management. The latter services include sourcing of comparator drugs and other supplies, establishing optimal delivery strategies across global trials, documentation support and the provision of regulatory advice regarding country-specific requirements.

Our team of pharmaceutical transport specialists is capable of supporting customer needs for the shipment of phase I, II, III and IV clinical trials materials, finished goods and raw materials. Worldwide customs pre-clearance capabilities proactively expedite delivery so that our experienced agents and associates located around the world can immediately clear and deliver shipments to their destinations. We guarantee speed of delivery with highly customized 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 to ensure the fastest, most secure and most reliable delivery possible, anywhere in the world, with no size or weight restrictions.

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, 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 with 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 organizations is no longer necessary. We can source comparator drugs and other supplies, establish optimum delivery strategies across global trials
and help closeout 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 have familiarity 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 optimization 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 maximize use of supplies and minimize waste and shipping costs while ensuring that products stay within specifications (e.g., temperature, pressure), creating efficient solutions for even the most complex supply chains.

We guarantee speed of delivery with highly customized 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.

The Benefits of a Flexible Partner

As a flexible, privately-owned business, Yourway works directly with our customers. We serve the pharmaceutical industry as a true one-on-one service provider. We offer our customers easy access to the top leaders of our organization, and nothing is ever off limits, day or night.

Formed in 2010, Yourway has maintained a commitment to our customers. Our attention to our customers has been unwavering over the last decade, in spite of our continuous growth, and we have grown more agile as we have expanded. Likewise, the roots on which we were founded have only become more deeply embedded into our organization. This emphasis on our company values and our organizational structure translates to increased benefits for our customers internationally. With a commitment to quality to a comprehensive service offering, integrated project managers who support our clients every step of the way and convenient packaging services and storage and depot assistance around the clock, customers who partner with Yourway BioPharma Services are tapping into a broader network managed by a team that will meet every challenge with a flexible solution.

Gulam Jaffer

Gulam Jaffer is President of Yourway, an integrated biopharmaceutical supply chain solutions provider offering a full range of primary and secondary clinical packaging, comparator sourcing, logistics, storage and distribution services for the global pharmaceutical and biotech industries. Headquartered in Allentown, Pennsylvania, with additional strategic locations worldwide, Yourway specializes in time- and temperature sensitive clinical drug product and biological sample shipments. Yourway is a flexible and reliable logistics partner committed to the safe, efficient and on-time delivery of clients’ high-value, high-priority clinical materials.

For more information on Yourway, view the Company Profile.

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