Fulfilling Global Temperature-Controlled Transport and Storage Needs for Clinical Trials

Abstract:​ With 21 facilities located globally and 260,000 ft²​ of total capacity, Yourway is dedicated to transporting temperature-controlled clinical trial materials, including ancillary supplies, around the world within mere hours. As nontraditional therapies continue to develop rapidly and progress into trials, the tools and tactics needed to preserve and deliver emerging medicines has also grown more complex. As an integrated clinical trial provider and the only true premium courier in the market, Yourway meets all logistic needs in an unprecedented turnaround time, allowing trials to continue as planned even during unprecedented events.

An Exposed Global Supply Chain​

Although the clinical trials sector has continued to function well throughout the ongoing pandemic, lessons learned from March 2020 continue to inform the current landscape. The pandemic exposed vulnerabilities in the global supply chain across industries, though its impact presented particular challenges for pharma. While the effects of COVID-19 extended to all phases of development, it was perhaps felt most acutely in clinical trials.

Clinical trials have grown increasingly global in nature owing to the need to test therapies on diverse patient populations. This, coupled with a laxer regulatory environment, ¹​ helps explain how deep the reliance on partnering abroad to bring a drug to market has become. For instance, a common trajectory might be a product or material being produced in Asia but having to be delivered to Africa before ultimately arriving in North America.

An already complicated global supply landscape grew in complexity when factoring in constantly changing restrictions, lockdown measures, and travel bans that became the norm during the pandemic. To combat a host of challenges that present daily but were heightened because of COVID and its impacts, relying on an optimal management solution for clinical material supply proved pivotal and made the difference between a halted trial (and thus wasted spend and resources) and a continued study.

Integration Is Key to Avoiding Logistic Challenges​

Before, during, and, after the pandemic, clinical trial decision-makers seeking a clinical trial logistics provider and courier stand to benefit the most from vendors that present an integrated offering. Depending on an organization with embedded, integrated capabilities is paramount to reducing risk and reaching the desired end result without getting bogged down by a never-ending litany of potential logistic troubles. With an offering covering the full gamut from the sourcing and delivery of drug products, comparators, and ancillary supplies to the collection of patient samples, primary and secondary packaging, and warehousing at locations around the world, Yourway is equipped to serve an organization’s transport and distribution needs from start to finish, regardless of how demanding or geographically remote.

Yourway is the only truly integrated premium courier and clinical packager on the market. In addition to offering a wide range of comprehensive transport services and options for shipping, Yourway provides primary and secondary clinical packaging services, warehousing, and distribution support, including temperature-controlled solutions and unused product return services — as well as product destruction and assistance with logistics project management. Taking care of all steps as a clinical trial provider includes the 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.

By integrating all of the services a client may need and handling everything in-house, Yourway has been able to streamline the supply chain, thus increasing the likelihood of success. Yourway has relationships both internationally and domestically that the company relies on to help clients daily, from getting ahead of issues with customs and local regulations to knowing how to manage clinical trial materials, supplies, and equipment — and to keep each package protected and temperature controlled. With an impressive network of global depots and unbeatable internal courier services, Yourway is able to deliver all relevant supplies to the right location at the right time, enabling clinical trials to proceed smoothly, regardless of whether they are conducted at a site or at a patient’s home — truly anywhere in the world.

Rescuing Trials with a DTP/DFP Offering​

While supply issues associated with the pandemic have subsided, takeaways from this unprecedented time continue to inform how work is done, from accepting remote staff to creating a hybrid or direct-to-patient (DTP) trial option for those unable to travel to a clinical trial site. Even before 2020, Yourway was at the forefront of the trend toward decentralized trials, helping move goods to regions not easily serviced by clinical trial providers.

As a pioneer in offering DTP and direct-from-patient (DFP) services, Yourway’s support of decentralized clinical trials is indicative of the lengths the company will go to reach its clients’ targets. Yourway’s experience with DTP/DFP trials has allowed protocols to progress uninterrupted, even when continuing seemed like an impossibility. Yourway is often requested to rescue trials that would not be possible to continue otherwise during the pandemic as a result of a less dedicated courier organization or logistic supplier who was not equipped to handle the crisis in as comprehensive a manner. In addition to having the resources needed to successfully implement a decentralized model, Yourway continues to build on this offering and refine the company’s toolbox. DTP/DFP capability gives Yourway’s clients an upper hand compared with competitors who lack this ability or don’t even realize the option exists.

Ultra-Cold Storage Capabilities​

Additional logistic challenges have arisen in the wake of early COVID-19, including issues with transit delays and ensuring packages remain within the required temperature ranges, especially as trials ramp up to pre-pandemic levels. To make sure patients in often remote areas receive potentially life-saving drugs while sponsors ensure their trials advance according to the timeline, multiple storage sites are vital. Cold storage capabilities can be a rarity, particularly in developing countries; however, this is a high-stakes situation, because, without the right temperature conditions, a drug is rendered useless. Needing advanced cold storage presents huge challenges in situations where electricity is lacking, let alone readily available liquid nitrogen and ultra-cold freezers.

To overcome these complexities and keep the clinical supply chain moving as expected, Yourway offers temperature-sensitive packaging. Temperature-sensitive packaging is essential for keeping valuable products such as cell and gene therapies viable even in extreme conditions and for an extended period of time, also taking into consideration potential delays in transit. Typically, while being stored and shipped before use, specimens are exposed to extreme temperatures that can fluctuate anywhere from –190 °C to 37 °C. Yourway addresses this by supplying the appropriate packaging for both primary and secondary packaging/storage and shipping and ensuring that all packers are properly calibrated and validated when appropriate to ensure that everything is functioning as it should.

With 21 depots located internationally, Yourway is able to store and service the clinical supply chain, no matter the temperature requirements. Yourway can store products all the way up to –185 °C, including typical storage at 15–25 °C, 2–8 °C, and –20 °C, and can handle whatever a client’s temperature-controlled storage needs may be. In addition to having a range of temperature-controlled storage depots that are accessible internationally, Yourway has integrated primary and secondary packaging services, allowing the company to house client materials within hours of a destination.

Trackable Shipping Container​

Packaging is another important component of shipping, and when dealing with expensive and highly sensitive products, packages must feature compliant chain-of-identity labelling unique National Drug Code codes for various dosing kits, as well as any other additional labeling text statements. These labelling requirements may impact label size and placement. As these packages are being transported internationally, having multiple labels with country-specific requirements in several languages adds another level of complication to shipping and labeling. In order to ensure packages are delivered as expected, Yourway relies on a sophisticated internal management system, as well as broad knowledge of regional requirements and country-specific regulations, such that labeling can progress appropriately and without error.

Yourway also provides clients with the ability to seamlessly manage their inventory through an easily accessible and highly intuitive customer portal. Yourway’s warehousing and logistics services are fully automated, which allows customers access to check on inventory at any time –– literally, 24 hours a day, seven days a week. This eliminates confusion or anxiety when dealing with shipping, as no item will ever just disappear, since each and every package is traceable and continuously accounted for.  Yourway supports its partners by assuming the risks associated with transport, replacing uncertainty with serenity.

Delivering Anywhere in the World​

Yourway can ship any clinical trial material, including highly sensitive drug products, to any location in the world, and at any temperature needed, all the way to –185 °C. To meet the needs of the industry so acutely and to go above and beyond for each request, Yourway relies not only on our best-in-class infrastructure but also, and even more importantly, on its people. The pharmaceutical specialists and dedicated project managers that comprise the Yourway team have the expertise needed to support all of our customers’ needs for the execution of phase I, II, III, and IV clinical trials, regardless of where they take place. These essential workers helped move the clinical supply chain forward even when the world was commanding it be halted. The pandemic yet again proved that people are Yourway’s greatest asset, as they go above and beyond on every project and request to provide the one-on-one tailored support needed to guarantee materials make it to their designated location on time and in full.

By providing all logistics services necessary for clinical trials and integrating these services, Yourway simplifies outsourcing and enables trials to progress according to plan, cutting out the middlemen and eliminating the stress of dealing with unnecessary vendor relationships. Clients that work with the Yourway team benefit from two decades of industry experience at home and abroad. Yourway has the know-how required to advise customers on the most optimal clinical trials logistics strategies, even when faced with an unprecedented or unpredictable situation, as was the case during the height of the pandemic. Around the world from the headquarters in Allentown, PA, Yourway can transport and ship clinical trial materials in a way that avoids using unnecessary resources or spend and makes continuing trials easier.

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