Cold Chain Logistics, Life Science Shipping

Improving Cold Chain Logistics for Decentralized Clinical Trials

July 13, 2023
Improving Cold Chain Logistics for Decentralized Clinical Trials

Decentralized Clinical Trials: Key Strategies for Efficient Implementation and Logistics Success

Written By: Debbie Jung

Since the COVID-19 pandemic, many health and life science companies, including diagnostic and medical device companies, have made an increasing effort to bring the hospital to the patient at home. By 2020 and onwards, solutions like telehealth became more widely popular among patients and companies. Among these patient-focused solutions, Decentralized Clinical Trials (DCTs) are being more accepted than others allowing more convenience, acceptance, and inclusion for the patients. As a result, clinical drug therapies or medical devices can increase participant recruitment and retention.  

In short, decentralized clinical trials (DCTs) are research studies conducted remotely, often leveraging digital technologies and virtual tools, to gather data from participants in their own homes or local healthcare facilities, reducing the need for physical visits to trial sites.

Now, patients who didn’t have opportunities to meet with the doctor or participate in a research study physically can attend from start to finish. Direct to Patient (DtP) and Direct from Patient (DfP) services are increasing and allowing development of drugs for diseases or conditions that were once overlooked. However, the success of DCTs relies heavily on detailed planning and seamless coordination of logistics, ensuring timely delivery of medications and samples at the right temperature. Understanding the pivotal role of decentralized clinical trial logistics in clinical trials is crucial and we will highlight the key strategies and considerations for efficient implementation.  

Strategic Partnerships: A Catalyst for Success

With all DCTs, there needs to be specific strategies in place whether that means partnering with a trusted logistics partner, hospitals, or pharmacies. By strategically planning these partnerships, you can create a comprehensive list of existing networks and identify areas where new partnerships are necessary. Leveraging this list to directly collect samples and send medications to clients will streamline the processes, particularly for time- or temperature-sensitive shipments. 

Mastering the Last Mile: Ensuring Timely and Secure Deliveries

Delivery represents the most critical stage of the shipping process. Direct-to-and-from-patient (DxP) shipments sometimes require last-mile delivery that is more hands-on than other shipments. Last-mile delivery offers clear visibility to all parties to ensure the safe timely arrival of critical shipments. This service allows real-time visibility, proof of delivery, and specific delivery instructions down to the room of the building you request. Ensuring the successful delivery of your shipment also involves effectively communicating with the recipient and capturing temperature-monitored data throughout the entire journey of the shipment. 

Decentralized Clinical Studies

Ensuring Accountability: GPS Tracking and Temperature Monitoring

On top of services like last-mile delivery, consider utilizing other cold chain supplies to monitor the success of your shipments Implementing 5G GPS trackers allows for precise location monitoring, optimizing future shipment scheduling and improving delivery accuracy. Numerous temperature monitoring devices are available, offering options for live 24/7 tracking or summarized and downloadable reports accessible upon arrival. Both types of temperature-monitoring devices are suitable for DxP shipments and highly recommended for utilization. 



“Decentralizing clinical trials will allow some or all trial-related activities to take place at trial participants’ homes or other convenient locations, instead of having them visit research sites. By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges.” - FDA* 


The Power of a Dedicated Team in Clinical Trial Logistics

The benefits of having a dedicated team of experts in clinical trial logistics are immeasurable. Having a dedicated team to manage all DCT logistics impacts the operational tasks and the efficiency that comes along with managing paperwork for regulatory compliances, risk mitigation, and specialized communication with catered solutions.  

Mercury: Your Trusted Logistics Partner  

Mercury specializes in cold chain logistics and boasts extensive experience in successful direct-to-and-from-patient shipments. We tailor our solutions to meet the unique needs of clients involved in clinical trials, offering expert guidance at every step of the way. With a dedicated group of logistics experts overseeing the coordination, tracking, and troubleshooting of your shipments, both shippers and consignees trust Mercury to deliver their time- or temperature-sensitive shipments to their final destinations. Our comprehensive range of cold chain supplies and white glove services, including last-mile delivery, demonstrates our commitment to continuously evolve and cater to our clients' needs. 


*source: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-steps-advance-decentralized-clinical-trials.

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