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Protecting Clinical Trials in Wake of COVID-19

In an unprecedented time of worldwide disruption, Yourway helps you navigate the critical supply chain journey for successful clinical trial development, execution, and conclusion.

In this ongoing global pandemic, which has leveled economies and curtailed research and development, launching or continuing trials represents a major hardship and challenge. As impacts from the novel coronavirus become more extensive, a major concern raised throughout the industry and the public is whether critical supply chains and clinical sites will be interrupted; this creates apprehension about whether patients can depend on a reliable supply of medicine, both for treatment and ongoing clinical trials.

This is on top of the fact that nearly 80% of conventional clinical trials do not finish on time, with 20% delayed for six months or longer; for a major drug, each day a trial is delayed amounts to a revenue loss of approximately $8 million, and about $600,000 per delay day for orphan drugs.

The Fulfillment of DTP/DFP

Those concerns may be allayed by working with a global leader in providing direct-to-patient (DTP) and direct-from-patient services (DFP) for decentralized/virtual trials, ensuring the pathways of supply and delivery are clear, efficient and reliable. Yourway has been the pioneer in this service platform for years and has a global network and substantial know-how to ensure continued uninterrupted human clinical trial execution and fulfillment.

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Direct-to-patient models of clinical trials have proven to positively impact efficient pharmaceutical development, as it improves patient retention, expands the ability to reach a dispersed population, and also bolsters patient satisfaction.

Yourway’s established experience in supporting various complex protocols provides your trial with reliable solutions to initiate rescue projects for DTP/DFP services in areas where other providers have not been able to operate. It also facilitates the implementation of DTP/DFP protocols to support sponsors seeking to transition from traditional centralized/virtual clinical trial models to decentralized/virtual models, allowing immunocompromised subjects to remain at home but still receive therapy.

While COVID-19 is threatening to impede research progress, Yourway has demonstrated operational resiliency during this unprecedented pandemic through its robust global network, experience with domestic and international logistics, strict adherence to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), including detailed business continuity programs, and its extensive experience in the clinical trial space.

Despite all the disruptions that COVID-19 has created, Yourway has maintained its operations by navigating to overcome all challenges globally. In addition to the strict GMP and GDP cleaning requirements already in place governing its facilities, vehicles, equipment and employee personal hygiene, Yourway has additionally taken internal measures to further augment these procedures. The company is monitoring the situation and the implementation of solutions during the ever-changing conditions created by COVID-19. These measures have allowed it to continue to efficiently support several ongoing global clinical trials while also protecting the integrity of the investigational product and ancillary products being stored and transported.

With the current shelter-in-place recommendations, clinical trial sponsors are seeking avenues for the delivery of care to their immunocompromised patients who require continued therapy. To mitigate this challenge, several centralized studies currently in place are being converted into decentralized/virtual studies to afford patients the ability to continue to receive treatment at home. The current experience should increase the number of sponsors who will utilize the decentralized/virtual model for their studies and incentivize faster adoption of the same model for more studies moving forward. Yourway has and will continue to assist organizations seeking to make this transition.

Most decentralized/virtual trials require in-home care services, in both pandemics and epidemics. e. From the onset of every project, Yourway designs solutions based on the needs of the patients, the sponsors and the healthcare professionals performing in-home care.  As a result, the DTP solutions implemented by Yourway are always based on patient-centricity, while offering safety, protocol and regulatory compliance, cost-efficiency and operational excellence.

Most recently, the number of requests for Yourway’s DTP courier services has increased significantly. Yourway continues to expand its ability to quickly review the requirements of each study protocol and create, present and deploy the most adequate, efficient, safe and reliable solution with a disciplined focus on patient-centricity, caregiver requirements, regulatory/quality compliance, and privacy requirements.

On the patient side, we understand the exaggerated stress level and fear of trial interruption. The homecare experience needs to be one of respectful sensitivity, knowing how to provide comfort and reassurance to patients and their loved ones who are additionally coping with stress associated with the treatment. Attention to details such as coordination of IP delivery to be executed exactly when the healthcare provider is arriving at the patient’s home, is one of the numerous white-glove services provided by Yourway.

This necessary shift toward DTP trials presents additional supply chain complexity, requiring the coordination of various systems and stakeholders to reach patients at the right time – at their preferred location. The expertise of a DTP/DFP expert enables researchers and drug developers to launch promising therapies. The DTP/DFP model also promotes while also promoting the maintenance and compliance of patient populations by providing materials and proper care in a manner that is convenient and safe for them.

The convenience of having one service provider and one project manager assigned to coordinate the planning and execution of services is more important now than ever. Yourway continues to excel at meeting our requirements while providing customized solutions to support clients’ missions of improving the outcomes of important studies.

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Everyone at Yourway embraces projects with great dedication, regardless of project size or scope. Our team is very driven. Yourway provides the best-customized solutions to support our clients in the noble mission of improving the outcomes of important studies, knowing that all these collaborative efforts will help improve the quality of life of patients enrolled in each study and of many other patients once the therapy is approved and launched commercially.

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