March 12, 2019 PAP-Q1-2019-CL-008
The number of clinical trials being conducted around the world has grown explosively. According to the National Institutes of Health, the number of registered studies has increased from 1,255 at the beginning of 2000 to 295,474 as of the beginning of 2019.1 Trials have also become more global, with nearly 50% of registered studies performed outside of the United States. Many require multiple sites in numerous countries to achieve the desired level of patient enrollment, particularly for trials involving orphan drugs for the treatment of rare diseases. Many of the drug candidates being evaluated today are temperature-sensitive biologics that require storage and transport at defined temperatures.
Trial design can be quite challenging for these studies. Drug manufacturers have therefore increasingly outsourced management of clinical trials to contract research organizations (CROs). Indeed, the value of the global market for clinical trials was estimated to be $40 billion in 2016, and the market is expanding at a compound annual growth rate (CAGR) of 5.7%.2
Getting clinical trial materials to patients and biologic samples to labs in a timely manner according to specifications can also be formidable. Thus, many trials sponsors have also turned to clinical logistics organizations (CLOs) to ensure that high-quality clinical trial materials are delivered to the right locations at the right times. In North America, the pharmaceutical logistics market, including temperature-controlled and non-temperature-controlled services, is expected to grow at a CAGR of close to 5% from 2018 to 2022.3 Globally, the clinical trial logistics market was estimated to be worth $3.4 billion in 2018 and is projected to increase to $3.7 billion in 2022.4
Year-on-year growth in global spending for temperature-controlled logistics services is estimated to be ~8% for the period 2016–2022 (compared with 2% for non-temperature-controlled logistics), rising from $13.3 billion to $18.6 billion over the period.4 In 2018, transportation accounted for ~$10.6 billion, while packaging and instrumentation were valued at $4.4 billion.
Over the last 20 years, Yourway has constructed a platform for managing the shipment of materials to and from anywhere in the world, with no size or weight restrictions. 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.
Yourway couriers are available to pick up shipments 24 hours a day, seven days a week, including weekends and holidays, with no cut-off times and no hidden or express fees. With many means of transport at our disposal, including on-board couriers, private aircraft charters, helicopter services and road transport, we are in a position to have all deliveries placed on the first available flight out to their destination using only premium options, regardless of when orders are received.
Once a shipment is in the air, we have a network of experienced professionals stationed around the world waiting to clear and deliver shipments to their destinations as soon as they arrive. Worldwide customs pre-clearance capabilities proactively expedite delivery. If any difficulties are encountered, they are dealt with immediately and effectively. All shipments can be tracked from Yourway’s central, web-based portal. The system even provides automated notifications once shipments have been delivered.
We consult with customers to review the global transport requirements for their valuable and sensitive materials, including import and export requirements for customs clearance. We offer distribution and controlled supply chain management programs and can also help with sourcing and provision of active packaging systems without size limitations and passive packaging supplies, such as insulated shippers, United Nations–certified shippers for all ambient refrigerated and frozen shipments, gel packs and phase-change materials, dry ice and temperature-controlled shipping containers and temperature monitors.
Our team of temperature-controlled transport specialists is capable of supporting customer needs for the shipment of phase I, II, III, and IV materials, finished goods and production raw materials. Yourway’s global network includes depots strategically located in various countries. Our temperature-controlled management services cover pick-up through delivery and include monitoring and gel pack or dry ice replenishment. We have experience handling ambient and controlled-ambient, refrigerated (2–8 °C) and frozen (–20 °C to –78.5 °C) products using both passive and active temperature-controlled systems. In fact, Yourway has the largest volume of passive temperature-controlled shippers in the clinical trials space.
We also have extensive experience with dangerous goods, controlled drugs, sample collection kits, ancillary products, medical equipment and other materials.
Our worldwide service also includes documentation support and the provision of regulatory advice regarding country-specific requirements. Customs fees are managed proactively and paid by Yourway, regardless of the cost — shipments are never held up waiting for the client to pay fees. Overall, Yourway’s proactive management approach helps our customers avoid delays of all kinds during the shipment of critical clinical trial materials.
Given the increasing complexity in the clinical trials space, Yourway saw an opportunity to leverage our strong Yourway Transport services platform to provide greater support to our customers. Formed in 2010, Yourway BioPharma Services offers, in addition to our comprehensive transport capabilities, primary and secondary clinical packaging services, warehousing and distribution support, product return services and assistance with logistics project management.
Integration of all of these services simplifies project management for our clients. All of the logistics needs for clinical trials can be obtained in one place. Outsourcing to and managing relationships with multiple organizations is no longer necessary. We can source comparator drugs and other supplies, establish optimal delivery strategies across global trials and help close out studies by returning unused materials.
To support international clinical trials, Yourway has invested in a global depot network that today comprises 20 locations in the United States, Canada, Mexico, the United Kingdom, Ukraine, Belarus, Russia, Colombia, Peru, Chile, Panama, Brazil, Israel, South Africa, India, China, Australia, Japan, Argentina, Slovakia and Singapore.
All of these facilities are GMP-compliant and include both ambient and temperature-controlled pallet and shelf locations, as well as controlled-drug storage areas. They also have designated receiving and shipping and pick-and-pack areas. In addition, the return and destruction of unused clinical trial materials can be managed at all of Yourway’s depots. Secondary packaging capabilities are also offered at some of the depots, and all participate in the company’s centralized web-based reporting system.
Yourway offers QP services as required by the Clinical Trial Directive 2001/20/EC and Annex 13 to the European GMP Guide. Our release procedures are reviewed by the MHRA, and we perform QP auditing of third-party manufacturing, testing, packaging and labeling facilities, as required in support of QP declarations for import into the EU. Overall, we proactively work to ensure continued compliance regarding all existing and new regulations.
In addition to our logistics expertise, Yourway has advanced warehousing capabilities for pharmaceutical industry customers, helping them to simplify their supply chains. As a warehouse partner, we make it possible for clinical trial materials and commercial drug products to be stored within hours — or even minutes — from destinations around the world.
Customers that outsource their material warehousing, inventory management and distribution with Yourway gain access to a wealth of strategic global locations and advanced management technology without the hassle of in-house oversight.
Like our logistics offerings, our warehousing services are fully automated, allowing 24/7 monitoring. When combined with our logistics support, materials can be shipped immediately on the next flight out or via ground transport as appropriate, regardless of when the order is placed. Customers that have combined our warehousing and logistics services have reported reduced overhead, field inventory levels, costs and — most importantly — turnaround times.
Drug manufacturers can gain even further benefits by leveraging our packaging services in combination with our logistics and warehousing support. We have primary bottling, blistering and over-encapsulation capabilities. When it comes to secondary packaging, we can provide any services a customer needs, including kitting, labeling, delabeling and blinding of placebos for clinical trials. These activities can be performed under ambient conditions or in a cold room or freezer if needed.
When packaging is completed, the product can be stored in the warehouse collocated at the depot or transferred in bulk to other depots as needed. Even if a job is finished on Friday night — because we control the transport — the material can be on a flight a few hours later. Arranging packaging, warehousing and shipping with Yourway allows for much shorter lead times than can be offered by most other service providers.
We take a solutions management approach to customer service. We do not simply offer logistics, warehousing and packaging support: we provide customized solutions to our customers. Customers that seek to leverage our experience and expertise to the maximum can benefit from an array of customized solution–based offerings, including project management support, planning and optimization guidance, comparator sourcing, ancillary supply sourcing, forecasting and returns/reconciliation management.
Advances in technology have made it possible for Yourway to develop the customized solutions we offer our pharmaceutical customers. We therefore embrace new technology on a continual basis and are constantly seeking opportunities to improve processes and create efficiencies to drive down costs and improve the patient experience. We also look to shift paradigms and break out of the same old clinical supply strategies.
In 2018, for instance, we invested in new labeling software that allows Yourway to perform more efficient in-house labeling of clinical trial materials. The software includes a language library that allows clients who are conducting more than one study to easily repurpose existing information, reducing validation requirements.
Yourway also has established capabilities in site-to-patient shipment. Patients can experience the convenience of having their medicines delivered to their homes or workplaces, while clients can be assured that the medicines will be maintained under compliant environmental conditions. We can also develop customized delivery solutions if patients will be traveling or moving to a new location, making it possible to keep all patients enrolled and receiving their medications.
Yourway is also committed to facilitating reverse logistics, including reclamation and value recovery, returns and reconciliation and, where appropriate, storage, consolidation, destruction or disposal.
Other areas where we are working to advance clinical material supply include time-sensitive labeling, support of investigator-sponsored trials and named patient programs and leveraging smartphone technologies.
Unlike other players in the clinical trial logistics space, Yourway offers highly personalized services to drive efficiency through quality and compliance. We have the bandwidth of a large firm, but remain attentive and responsive to our customers’ individual needs. We offer true one-on-one customer service that ensures high-quality, responsive, tailored support from start to finish.
As importantly, our people have decades of experience in pharmaceutical logistics and are the key to our rapid growth. They help clients avoid wasting resources and ensure adoption of the most efficient clinical trial logistics strategies. Indeed, many virtual pharma companies turn to Yourway to manage their entire clinical trial logistics programs.
Time is of the essence in drug development and commercialization. Being first to the clinic and first to market is essential in the industry today. As such, the greatest benefit Yourway provides to our customers, who range from small virtual biotechs to mid-size and large pharma companies, is shortened turnaround times. We are structured to get materials out the door today — never tomorrow. We negotiate timelines with our vendors, which allows us to turn projects around more quickly.
Our rapid growth reflects the value we provide. The number of shipments per month made by Yourway has been rising steadily. From June 2016 to May 2017, for example, the total shipments per month — all of which were delivered on time — nearly tripled. Our quality metrics for total shipments speak loudest: 99.9% accuracy.
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.