Today’s post-pandemic clinical trial landscape will require a patient-centric supply chain strategy.
It is no argument that the impact of the global pandemic on the pharmaceutical and life science industries has been direct and cataclysmic. However, it provided a crucial inflection point on the future of how we conduct clinical trials, intensifying the essential need for operational resiliency and agility.
After more than 80% of ongoing clinical trials were disrupted, the industry quickly pivoted, accelerating the development and implementation of decentralized and hybrid clinical trials. “Enrollment in clinical trials dropped drastically as patients were quarantined or reluctant to travel, making trips to hospitals or research sites incredibly difficult, if not impossible. As a result, the industry, while historically slow to embrace new solutions, adopted decentralized models; either hybrid or fully virtual at an unprecedented pace due to COVID-19,” comments Ariette Van Strien, president of Marken, a market-leading supply chain and hybrid DCT solutions provider.
While DCTs aren’t a fit for every therapeutic indication, they offer many remarkable advantages over traditional trial models: the burden is much less for participants, there’s access to a much broader and more diverse patient pool, and the ability to scale from a geographical perspective.
DCTs come with their own set of challenges and complexities, however, supply chain strategy is perhaps the most critical (and highly underestimated) aspect. “DCT trial teams are faced with management of multiple vendors and a complex web of suppliers — and it is critical to find a logistics partner that offers flexible, end-to-end supply chain services,” notes Van Strien. That’s an advantage for Marken, which specializes in the delivery of single-source clinical trial logistics solutions and patient centricity while leveraging the UPS Healthcare division — the largest supply chain provider in the world.
To continue to drive improvements in clinical trial recruitment, retention, and adherence and allow patients to continue trial enrollment in convenience of their own homes, Marken specializes in patient-centric services such as Direct-To/From-Patient with a global nursing network for home healthcare solutions. Understanding local regulations and a heightened focus on technology integration and data security adds to Marken’s ability to improve the overall patient experience.
“A strategic partner like Marken provides solutions that offer advantages for both patients and clinical trial researchers,” says Van Strien, “including global patient support.”
Marken provides direct communication lines between patients and our experts with dedicated Patient Communication Centers (PCC) for 24/7 end-to-end support along each step of the care journey. Located in Philadelphia, Edinburgh, and Ciudad de México, these state-of-the-art centers support 14 different languages and serve as single points of contact for trial participants.
Marken’s home healthcare services have developed a leading-edge 21CFRPart11-, HIPAA-, and GDPR-compliant home healthcare technology. The cutting-edge technology makes collecting real-time data easy, and lets users see the overall study progress as well as specific patient histories, all using secure technology.
Marken also recently partnered with leading decentralized clinical trial technology provider THREAD for seamless site interactions, and continues to partner and integrate with major companies in the digital and decentralized trial space including existing clinical trial platforms like EDC and IRT solutions. These partnerships solidify Marken’s unique position to support hybrid and virtual trials, as well as associated telehealth needs.
Evolution in this industry is a matter of survival, and for the last ten years, while some solutions were considered too risky, now the risk is not adopting them soon enough. There is little doubt that DCTs are here to stay, and many of the adaptations that took place during the pandemic will last and continue to support improvements and enhancements in the clinical trial landscape for many years to come.
Additionally, new technology advancements, such as artificial intelligence (AI) and big data, focus on digitization and data interoperability that will further drive a revolution in healthcare, transforming clinical trials and fueling modern drug development.
Van Strien believes we’re still just beginning to see the impact of DCTs. “Decentralization may be the future of clinical research. Marken is committed to staying one step ahead as hybrid and virtual trials continue to accelerate. Not just from a from a logistics or technological perspective, but to support patients throughout the entire healthcare journey.”
Discover more about how Marken delivers solutions for tomorrow’s clinical trials at www.marken.com/capabilities/direct-to-from-patient