TECHNOLOGY SPONSOR: Cold Chain Logistics
Yourway, one of That's Nice's Road to 2021 sponsors, discusses how the company is envisioning the future of the pharma/biopharma industry.
With the industry facing an uncertain future as we continue to work to move forward past the COVID-19 pandemic, some changes that will impact the future of clinical trials seem clear.
First, we can anticipate that clinical trials going forward will rely much more on decentralized, virtual, and hybrid models, with direct-to-patient (DTP) and direct-from-patient (DFP) logistics services becoming critical. These evolving approaches to clinical trials were already gathering momentum owing to their patient-centric benefits, as well as their potential to simplify recruitment and retention for clinical trials for rare diseases with geographically dispersed populations — and in 2020 became indispensable to allow trials to continue while assuring the safety of participants and site staff during the pandemic. With sponsor companies that had previously been hesitant to adopt these new approaches seeing their benefits during the COVID-19 crisis, we believe that many will continue to pursue them even once it is possible to return to traditional, site-based clinical trials. This will expand the demand for clinical trials service providers who can fully support these trials, including via comprehensive DTP/DFP services.
The second likely trend resulting from the pandemic and its response will be an even-greater emphasis on finding new ways to accelerate clinical trials. Again, even before the pandemic, sponsor companies and regulatory agencies were motivated to find ways to speed up clinical trials and get drugs to market as quickly as possible, reflected in the increasing embrace of Fast Track and other accelerated approval designations. The rush to approve vaccines and therapeutics for SARS-CoV-2 and growing evidence that it is possible to do so much more rapidly than traditionally believed are changing expectations regarding clinical timelines, a shift that is likely to continue for the foreseeable future. Sponsor companies will be looking for clinical trials providers who are sufficiently agile to maintain the same high standards of quality and transparency while moving more quickly than ever before.
Yourway has built a reputation on excelling during challenging times when other providers cannot. We have pioneered DTP/DFP services for a variety of complex protocols to create reliable, successful strategies to support decentralized or virtual clinical trials, whether that means transitioning trials originally planned to be held at centralized sites, rescuing decentralized trials initiated by other providers who were not able to provide sufficiently robust solutions to ensure trial continuity during these challenging times, or planning truly decentralized trials from their inception.
Yourway is also well positioned to support clients as we collectively work to reduce clinical timelines, owing to our integration of a range of key services. We do not simply offer a suite of discrete services — logistics, warehousing, and packaging support — but take a solutions management approach to all projects, combining project management support, planning and optimization guidance, comparator drug and ancillary supply sourcing, forecasting, and returns/reconciliation management, to provide customized solutions for each client’s need. Integration of this full range of clinical supportive services translates into unmatched quality, speed, and operational efficiencies.
Regardless of the uncertainty ahead and new needs that may emerge over the next few years, Yourway is ready to support our clients and overcome these challenges to face the future of healthcare.