Clinical Trials Face Increasing Challenges
The COVID-19 pandemic emerged at a time when the clinical trial landscape had reached a peak in complexity. Global trials are now commonplace as drug makers seek to establish efficacy in diverse populations. Many of the therapies in clinical studies target rare diseases, with patients located in remote and disparate regions. The need to demonstrate improved performance over existing drugs also means that comparison studies are more widespread.
The growth of biologics, next-generation therapies, such as cell and gene therapies, and personalized medicines, all of which present an even higher level of logistics and transport challenges are driving the need for more complex solutions.
The pandemic created additional obstacles for the clinical supply chain. Lockdowns and restricted travel impacted manufacturing and logistics operations around the world. Many existing and new trials adopted virtual (direct-to-patient, DTP) trial practices in order to continue.
Overcoming the Growing Hurdles Requires an Integrated Solution
Ensuring continued operation of clinical trials under these difficult conditions requires an optimal management solution for clinical material supply, which can only come from an integrated clinical trial provider focused on the pharmaceutical industry with services covering the full gamut from sourcing and delivery of drug products, comparators, and ancillary supplies, to the collection of patient samples, to primary and secondary packaging and warehousing at locations around the world.
Integrating as many services as possible from a single provider streamlines the supply chain and reduces sources of risk, delays, and cost. With internal courier services, longstanding international and domestic industry relationships, global, integrated networks of depots and storage facilities, knowledge of customs regulations, and an understanding of the importance of managing all clinical trial materials, equipment, and supplies under appropriate conditions and delivering them to the right location at the right time, integrated clinical trial providers enable clinical trials to proceed smoothly, whether they are conducted at a predetermined site or patients’ homes.
Yourway Addresses these Challenges
Yourway is a truly integrated clinical packager and premium courier. We provide logistics, warehousing, and packaging support while also offering an array of solution-based offerings, including project management support, planning and optimization guidance, comparator sourcing, ancillary supply sourcing, forecasting, and returns/reconciliation management, among others.
Yourway is a trustworthy and experienced partner that can be called upon for advice in a space that is notoriously difficult to navigate. We are recognized in the industry as a leading integrated premium courier and clinical packaging service provider that is both reliable and experienced. As the only truly integrated clinical packager and premium courier, we provide faster service, facilitating clinical trials so they can take place more efficiently without compromising quality.
Delivering Supplies to a Conflict Area
By late spring 2021, Israel was simultaneously faced with ongoing impacts from the COVID-19 pandemic and active conflict in the region. Despite the challenging conditions, clinical trials were still being conducted in Israel, and clinical trial materials still needed to be delivered. That was not always easy. In one case, a large European pharmaceutical company contracted with a courier service to deliver approximately 25 bulky shipments to Israel. Flights to Israel from Germany near the Frankfurt area were unpredictable and, for some periods, halted altogether, leading to a backlog of shipments, including those clinical trial materials.
The pharmaceutical company turned to Yourway for help. We work with this drug maker in Australia, New Zealand, and some Asian countries, so they had experience with us. They needed a logistics partner that could be relied upon to take care of these shipments, and that was Yourway.
Yourway took custody of the shipments from the original courier company and went to work finding a solution. As a result, the materials were efficiently transported, cleared by customs, and delivered to the receiving site within 48 hours.
Bringing Trials to Patients Under Lockdown in India1
An American biopharmaceutical company focused on researching and developing antiviral drugs was conducting a combined phase IIb/III, double-blinded, randomized placebo-controlled study in India evaluating the efficacy and safety of an investigational medicinal product (IMP) for the induction and maintenance of remission in moderately to severely affected patients with different viral infections.
The initial trial design had patients visiting specific trial sites for treatment and follow-up visits. Due to the COVID-19 pandemic outbreak in mid-2020, enrolled patients could no longer come to these sites due to nationwide lockdown measures introduced in India. To avoid trial disruption and ensure that patients continued to receive treatment, the biopharma company needed support and solutions for delivering the IMP with complete temperature integrity and urgency from sites to patients’ homes.
The vast geographically and demographically diverse locations in India, unfavorable infrastructure, and the closure of trail, road, and air services posed very critical challenges for delivering the IMP from clinical sites (largely hospitals in metro locations, including Mumbai, Delhi, Bangalore, etc.) to patients in the required temperature ranges and timelines.
Despite restrictions on the movement of people and vehicles for inter- and intrastate transfers, Yourway created solutions that allowed the delivery of these investigational medicines during the nationwide COVID-19 lockdown. Special permissions were obtained from local police and other government agencies for Yourway vehicles to transport these lifesaving investigational medications and to ensure their delivery to patients located in cities as far as Yawatmal in Maharashtra, Ruby Medical Hall Pune, and Gaya in Bihar from the AIIMS Hospital in New Delhi.
Yourway deployed dedicated vehicles and experienced trained staff to effectively execute direct-to-patient (DTP) shipments around the clock. General Data Protection Regulation (GDPR) rules and local regulations were properly followed, ensuring the completion of required patient forms. Robust ready-to-use validated passive packaging solutions equipped with data loggers enabled the transport of materials requiring temperature control at various temperature ranges (–180 °C, –80 °C, –20 °C, +2 °C to +8 °C and +15 °C to +25 °C).
As a result of the solutions engineered by Yourway’s experienced staff, patients were able to receive their treatments timely per the dosing schedule prescribed in the study protocol.
Changing Ways of Working under Brexit during a Pandemic
Similar challenges existed in the UK and Europe during the COVID-19 pandemic, and these were compounded by issues related to Brexit. Transportation of goods between the UK and Europe was fraught with questions. Borders within Europe were closed, and flights were cancelled. As a result, travel was highly restricted.
Yourway accepted the challenges here, as well. We changed our mentality and way of working and focused on finding alternative solutions. When possible, we used different flight routes and airlines we had not leveraged in the past. We also did a lot of driving across Europe. In some cases, we could get flights part-way to the delivery destination, and then drive the packages the rest of the way.
We also implemented multiple backup solutions to be prepared for unexpected delays and issues. For instance, for shipments that required strict temperature control, we might book a spot on an airline and use packaging with sufficient cooling capability for the expected delivery timeframe, but also have a temperature-controlled vehicle available if the flight was cancelled to ensure that the package stayed cold for as long as needed.
In addition, if there was an issue in transit, we were able to repack materials into other temperature-controlled shippers or even add dry ice –– whatever was necessary to maintain the temperature. Contingency plans were always in place.
Our flexibility and agility derive from Yourway’s company culture and the way we work. We are in essence similar to a big family. As the operations director, I often speak directly with the logistics coordinators and even our drivers, because we have a personal way of working. No one in any position is afraid to get their hands dirty. At the same time, we expect change. We have built-in flexibility and are therefore able to adapt very quickly to changing situations.
Fortunately, throughout the pandemic and even in the context of Brexit, governments have continued to recognize the importance of delivering medicines, whether to hospitals or directly to patients. In some cases, customs clearance was slowed due to COVID-19 work practices, such as limited staff working in shifts to ensure proper social distancing. All countries, of course, had procedures in place to ensure the quick clearance of COVID-19 vaccine shipments.
Truly Integrated and Personalized Services
Yourway is the only truly integrated premium courier and clinical packager, offering — along with our comprehensive transport capabilities — primary and secondary pharmaceutical packaging services, warehousing, and distribution support, including temperature-controlled solutions, unused product return services, including product destruction, and assistance with logistics project management. The latter services include 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.
Our team of pharmaceutical specialists is highly experienced in supporting customer needs for the execution of phase I, II, III, and IV clinical trials. With all logistics needs for clinical trials easily obtained in one place, outsourcing to and managing relationships with multiple organizations is no longer necessary. Our people have decades of experience in pharmaceutical logistics and help clients avoid wasting resources and ensure adoption of the most efficient clinical trial logistics strategies. They also provide true one-on-one customer service that ensures high-quality, responsive, tailored support from start to finish.
Yourway’s position as a pioneer in offering DTP and direct-from-patient (DFP) services to support decentralized clinical trials globally reflects our commitment to meeting the needs of our customers. During the COVID-19 pandemic, our extensive experience with DTP/DFP services helped many clients avoid trial disruptions by facilitating the transition to a decentralized model. We also rescued several studies where other logistics providers were not able to operate efficiently during the pandemic. Yourway brings solutions to study teams to ensure trials run efficiently while maintaining focus on patient centricity, quality, and regulatory compliance.
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References
- Rizvi, Syed Nasar Hasan. “Direct-to-Patient Logistics: Decentralized /Virtual Clinical Trials.” Yourway white paper. 13 May 2021.
