The pandemic remains a globally disruptive entity that can impede efficacy of clinical trials. Choosing the right partner helps you concentrate on obtaining optimal results from at-home populations.
It is quite clear that the 2020 COVID-19 pandemic, which is currently history in the making, is still robust with no signs yet of cessation. The world itself must go on – especially clinical trials that continue to improve medicine and medical devices. But with the sharply altered landscape, you need to ensure your trial is safe from the travails that can impact at any point along the way from direct-to-patient (DTP) and direct-from-patient (DFP).
Even prior to the pandemic, DTP models of clinical trials have been proven to positively impact efficient pharmaceutical development, as it increases patient retention, expands the ability to reach a dispersed population, and also bolsters patient satisfaction. Now, it is increasingly becoming the norm and will likely be the common way human clinicals are performed post-COVID.
Prior to COVID-19, approximately $2.28 billion has been spent by pharmaceutical and other companies recruiting patients, and there has been a staggering rate of failure to finish on time (nearly 80%), or to retain the number of patients through conclusion (85%) -- according to the Office of the Assistant Secretary for Planning and Evaluation, US. Department of health & Human Services.
And this is before the pandemic created severe impairments and hurdles in the clinical trial process. Pre-COVID, every day that a trial was delayed would puncture the bottom line by devouring hundreds of thousands of dollars – and of course on the other end, potential lost revenue incurred by the product not being on the market.
For years, the industry has been gradually transitioning into decentralized/virtual clinical trial models. These create a more patient-centric experience, which has been reported to help increase patient retention, protocol compliance and data quality. During (and post) COVID-19, the patient-centric model has and will become more dominant by necessity.
A global leader that knows how to navigate the complex field of decentralized/virtual trials and that can ensure that the pathways of supply and delivery are clear, efficient and reliable is the only partner you need to navigate your trial successfully, on time.
Yourway, an integrated premium courier and clinical packager in the global clinical trials supply chain market, has been a pioneer in this service platform and has constructed a global network and substantial expertise to ensure continued and uninterrupted human clinical trial execution and fulfillment.
Despite the current global pandemic, Yourway is operating at 100% efficiency and is continuously seeking ways to increase capacity to compensate for potential supply chain gaps created by changing travel restrictions and interruptions in the services of other providers. “Our direct-to-patient (DTP) services are operating globally without interruptions,” assures Gulam Jaffer, President of Yourway. “Additionally, we have successfully initiated rescue projects for DTP services in areas where other providers have not been able to operate.”
Yourway also has protocols in place to facilitate customers seeking to transition from traditional centralized clinical trials models to DTP models, allowing immunocompromised subjects to remain at home but still receive therapy.
Paramount to Yourway’s operational resiliency during this unprecedented pandemic is 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. In uncertain times, clients need to be certain of the quality and safety of clinical materials through the entire supply chain journey.
And Yourway’s abilities have been both expanded and fortified through strategic collaborations. For example, a recent key alliance with a notable niche service provider for patient-centric home healthcare, provides coordinated supply and product deliveries and administration services for virtual/decentralized clinical trials of all types and sizes. “The collaboration enhances others we have with specialized providers to better support patient retention and compliance, while also helping CROs and sponsors improve the efficiency of clinical trial management,” Jaffer explains.
Clinical products and equipment are coordinated to be sent directly to the patient. In addition, collected bodily samples and other materials are shipped from the patient’s home through a courier. In-home patient care is performed by an approved healthcare provider.
Yourway’s expanded abilities has perfect timing. Direct-to-patient models of clinical trials have proven to positively impact efficient pharmaceutical development. The current experience should increase the number of sponsors who will embrace the decentralized/virtual model for studies and incentivize faster adoption of the same model for more studies moving forward.
Reliability During and After COVID
Yourway’s team of experts proactively monitor the global pandemic situation and implement solutions during the changing conditions brought forth by COVID-19. All these measures have allowed Yourway to continue to efficiently support several ongoing global clinical trials, while protecting the integrity of intellectual property and ancillary products being stored and transported. As an example, with current travel and social distancing restrictions in effect, Yourway offers virtual audits to protect the health and safety of employees, clients and stakeholders, allowing auditors the ability to conduct full audits with real-time access to Yourway’s facilities and documents from anywhere they are located.
Challenges vary and can heavily impact a trial, even causing it to halt – especially in a pandemic. Yourway’s capabilities will greatly reassure the companies whose tremendous investments in the trials are critical to protect. Yourway and its collaborative team perform:
- Procurement of comparator drugs and ancillary supplies
- Primary and secondary clinical packaging
- Translation services
- Label and booklet printing
- Qualified Person (QP) releases
- Importer of Record (IOR) and customs brokerage services
- Specialized temperature-controlled transportation and storage for all temperature ranges from minus 180 degrees Celsius to controlled 15 to 25 degrees Celsius.
- Temperature-controlled storage at one of Yourway’s 21 global GMP depots strategically located in all continents
- Integrated in-home healthcare services
- Returns and destruction services with full accountability
Meanwhile, on the patient side, Yourway’s team understands the intensified stress level and fear of trial interruption. The homecare experience is approached with respectful sensitivity, and the knowledge of 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 intellectual property 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,” explains Jaffer.
Yourway assigns a project management team including a project manager to each study; the team works closely with clients to analyze and understand the complexities and unique needs of the study protocol. The team creates solutions based on the needs of the patients, of the sponsors and of the healthcare professionals performing in-home care. As a result, the DTP solutions Yourway implements are always based on patient-centricity, while offering safety, protocol and regulatory compliance, cost-efficiency and operational excellence.
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. This pandemic will eventually recede and be under control, but epidemics will appear before they too are contained. Through it all, DTP studies will be ongoing throughout the globe and Yourway will be there to ensure safe success.