Supporting a Dynamic and Evolving EU Clinical Trials Landscape

Yourway's Dublin, Ireland Flagship Depot Supports a Dynamic and Evolving EU Clinical Trials Landscape

The field of clinical trials is characterized by a dynamism and pace of growth unmatched by any other discipline in the world. While the science underlying healthcare evolution is undeniably innovative, the foundational biopharma services that support and drive clinical trials - planning, procurement, project management, logistics, packaging and more - are also critical to their success and play a primary role in the advancement of human health. 

For more than 25 years, Yourway has designed and grown the only fully-integrated biopharma services company to provide comprehensive support for clinical trial operations. To support the dynamic changes and growth of clinical trials in the European Union (EU) and Britain, Yourway has established a new EU flagship depot at Dublin Airport Logistics Park, Dublin, Ireland. Joining Yourway’s 22+ strong global depot network, the fully GMP-compliant Dublin depot is an important global hub that provides a gateway to a significant domestic clinical trials market, international logistics reach, and access to a far-reaching air transport network throughout Europe and the globe. 

The Evolving EU Clinical Trial Landscape Requires Full Biopharma Services Integration

Yourway’s Dublin depot provides a fully-integrated suite of biopharma operational competencies to support EU-based clinical trials, including full GMP compliance, temperature control services and cold-chain logistics, clinical packaging services, procurement, and regulatory support. Given the evolving and dynamic nature of the EU clinical trial market, integration of biopharma support services is key to clinical trial success moving forward.

Multinational clinical trials of EU origin have risen by 22% since January 2022, with an average of seven EU member states involved in any given study. As well, clinical trials have been widely, and nearly evenly, dispersed throughout the continent, with 17 % occurring in the northern EU, 25 % in southern EU, 27% in western EU, and 31% in eastern EU. In 2022, there were 13,066 clinical trials in Europe, outpacing the entire Western hemisphere by more than 1,000 studies (11,935). It’s clear that the hallmarks of the EU clinical trial landscape are growth and integration.

Clinical trial sponsors in the EU have also had to navigate massive regulatory changes as the EU Clinical Trials Regulation (EUCTR) became available on January 31, 2022, and subsequently went into full effect in January 2023. EUCTR’s primary goal is to increase integration and coordination of clinical trials and regulatory bodies among EU member states.

And, even the nature of therapeutic innovations is demanding integration of operational competencies. Personalized therapies are growing quickly, most notably cell and gene therapies (CGT), which have recently outpaced the success rate of small-molecule compounds by 34%.  For CGT clinical trials, there are several operational and logistics challenges that can compromise study endpoints or successful patient treatment, including delays and temperature fluctuations. The various operational components and processes for these types of clinical trials are interdependent and non-siloed, requiring the highest levels of integration to ensure patient safety and treatment efficacy.

In such a dynamic milieu, it’s clear that operational integration of biopharma services is paramount to clinical trial success and continued therapeutic innovation. Yourway’s Dublin depot provides a central hub for full service integration within a study, across study sites, and among regions of study operation. This level of integration has been cultivated and honed over decades throughout Yourway’s global GMP depot network.

Temperature-controlled and Cold-chain Logistics

Temperature-controlled storage and transport have become central to healthcare and therapeutic development. Global refrigerated storage capacity grew by 32% from 2014-2020, accelerated by a 17% increase  during the 2020 COVID-19 pandemic. Innovative new biological therapeutics (biologics) including cell and gene therapies (CGT) are driving temperature-controlled and cold-chain logistics growth, along with the need for global distribution of mRNA-based vaccines. Biologics have more than doubled as a percentage of therapeutic approvals since 2000, and continue to rise. CGT products alone now account for approximately 12% of clinical pharmaceutical pipelines, with more than 1,200 CGT clinical trials in the global pharmaceutical pipeline in just 2022. 

Clearly, cold-chain logistics (CCL) and temperature-controlled storage and transportation (TCST) play a critical role in clinical trial success. CCL and TCTS are a critical aspect of ensuring advanced therapies reach their intended patients at the right time, requiring precise coordination and handling of biological materials and involving numerous disparate stakeholders spread throughout the therapeutic process. Yourway’s Dublin depot, and Yourway’s global operations in total, are fully-integrated, ensuring that CCL and TCST are coordinated with all aspects of their biopharma services.

The Dublin depot is capable of a full range of temperature controlled operations, from controlled-room temperature down to -185°C cryogenics, to support the complete clinical trial value-chain. This includes storage and transportation and is fully integrated with Yourway’s clinical packaging capabilities and various project management services.

Clinical Packaging 

Clinical packaging encompasses both primary and secondary packaging, including clinical trial kit design, and labeling services. Yourway’s Dublin depot is custom designed to support GMP-compliant facilities to support all three packaging needs, ensuring therapeutic safety, quality and integrity.

Primary packaging services provided by the Dublin depot consist of bottling, encapsulation, over-encapsulation and blistering, including repackaging of investigational medication. Repackaging of comparator drugs and placebos is accomplished in coordination with procurement services — for comparator drugs, placebos, ancillary supplies, and more — and fully integrated with storage, transportation logistics, and temperature-controlled services, all in the same facility.

Yourway also provides secondary packaging – specifically, kit design, or kitting, services – through the Dublin depot. Kitting may include study drugs, placebos, comparator drugs, and possibly ancillary supplies, for example syringes or gloves. Kitting requires design for ease of use, minimization of space and materials, and maximization of package integrity. Full integration of all of Yourway’s services ensures that every consideration — including how kits will travel and be used from beginning to end — is considered and fed into better kit design.

Project Management, Procurement, and Regulatory Support

Dublin, Ireland is a major international logistics and travel hub, and the Dublin depot’s position there offers Yourway’s client partners customizable single-source control across all of their clinical trial biopharma needs. Full integration through the Dublin depot allows precise and ongoing tunability of operations, as well as just-in-time logistics for decentralized and hybrid clinical trial designs. Yourway also offers full procurement services for drugs and ancillary supplies throughout its global depot network.

Yourway also provides regulatory support, including:

• Qualified Person services for approval of investigational drug or pharmaceutical product shipments into the EU, which require Qualified Person approval. 
• Importer Of Record services to ensure goods are brought into, and transported throughout, the EU with proper adherence to regulatory structures of the EU member states.
• Customs Brokerage services to ensure frictionless customs clearance as products cross international borders.

Conclusion — A Gateway to Smoother Clinical Trial Logistics

Yourway is proud to bring the fully-integrated biopharma services of its 400,000 square foot Dublin depot online in support of the innovative community of EU pharmaceutical developers and manufacturers. Now is by far the most dynamic and promising era in therapeutic development, an emerging epoch in healthcare improvement and acceleration. As innovative therapeutics grow in complexity, the biopharma services that act as the foundation on which they are realized must innovate and grow as well. This is Yourway’s ethos, and the integrated service offerings of the new Dublin, Ireland GMP-depot exist to support and drive EU biopharma innovation throughout the 21st century and beyond.