ENTERPRISE SPONSOR: CRO
SanaClis, one of That's Nice's Road to 2021 sponsors, discusses how the company is envisioning the future of the pharma/biopharma industry.
Over the coming decade, SanaClis believes that patient centricity will become the central focus for the entire industry, with individualized treatment regimens and personalized treatments fast becoming the dominant therapeutic paradigm. A patient-centric approach, with personalized medicine supported by robust technology-enabled RBQM, will become the new norm following COVID-19, upending the traditional but outdated business models in the clinical trials industry.
Clinical trial protocols during the pandemic, and most likely post-pandemic as well, will be dominated and designed around home care for patients — both in terms of clinical trials and commercialized medicines; a trend that seeks to ease access to medication for patients while reducing the patient burden. As the COVID-19 pandemic makes hospitals, clinical trials sites, and treating physicians less accessible, particularly for immunocompromised patients or those with other underlying health conditions, it is imperative to design studies with a patient-centric focus, in order to significantly reduce disruption in clinical studies as seen throughout 2020. With growing uncertainty as to the required duration of pandemic measures aimed to mitigate COVID-19, the industry needs to seek new ways to conduct procedures in patients’ homes, assisted by nursing networks, with the ability to conduct more complex home care treatments, such as administration of investigational medicinal products (IMPs). SanaClis — in collaboration with many large pharma companies — is proud to be instrumental in pioneering development and implementation of such home care approaches into ongoing studies, as well as new studies planned to start in 2021.
Mindful of the changing needs in clinical trials of the future, SanaClis continues to analyze and implement newly emerging and disruptive technologies with the potential to transform how clinical trials are conducted, with a particular focus on digital technologies enabling adoption of decentralized or hybrid clinical trials as a new norm. Rapid and smart adoption of AIML at scale and powering next-gen RBQM through real-time data interoperability hold great promise to address the growing dilemma as to how to handle increasing volumes of study data without adverse impacts on study duration.
In the context of the evolving adoption of home care procedures and treatment administrations that will transform patient experiences, it is important to consider the impact upon the supply chain and realize changes necessary to support it. The industry must seek to improve quality and accountability in regard to the transportation, dispensing, and storage of clinical trial supplies for effective home care delivery. While this paradigm shift may initially pose a strain on the existing supply chain, it will in practice create new efficiencies.
SanaClis is at the forefront of change to mitigate the impacts of the COVID-19 pandemic, as we develop patient programs and designed Patient Compliance and Protection Kits to support safe conduct of clinical trials for hospitals, doctors, site staff, and, importantly, the patients.
SanaClis remains committed to promoting and supporting implementation of patient-centric decentralized clinical trials. SanaClis’s core belief is that the patient remains at the very heart of everything we do and how we innovate; the COVID-19 pandemic has only reinforced that belief, and, with the combination of strong cross-industry collaboration, research, teamwork, and adaptability, SanaClis welcomes the opportunity to overcome current and future challenges of such magnitude.