July 1, 2020 PAP-Q2-20-RT2-011
As the industry explores the future of clinical trials and healthcare overall, it is key for all companies to find new ways to innovate. The clinical trials industry is among the most tightly regulated industries in the world, so innovation and adaptation of clinical trial models and practices requires collaboration from a variety of stakeholders. As such, SanaClis has established a corporate culture that prioritizes precision and transparency, both with their clients and with global regulatory bodies.
The industry will never be the same as it was before COVID-19. It is critical that all stakeholders are proactive in gathering and analyzing data from the pandemic to ensure that lessons are learned and preparedness is prioritized going forward.
SanaClis had extensive contingency plans in place for a crisis of this nature that enabled the company to rapidly respond with measures that ensured the safety of clinical trial participants without interrupting ongoing trials. For example, the company introduced new patient Safety and Compliance Kits. Despite the wider shift from traditional, centralized clinical trials toward virtual or siteless trial models, made possible by direct-to-patient (DTP) services, many trials still require some level of hospital visits, if only sporadically. SanaClis perceived an acute need for products (PPEs) that could maintain compliance with trial protocols while minimizing potential exposure to SARS-CoV- 2, guaranteeing the safety of patients and site staff, while keeping in mind the daily life of the patient outside of the study surroundings.
However, this degree of preparedness was not universal throughout the clinical development industry, and it is important, therefore, to assess where bottlenecks are occurring and to implement necessary changes for the future. Many companies did not have appropriate contingency plans in place, which created delays in the provision of services and vastly impacted study timelines. It is essential that such plans are pre-established if a second wave of COVID-19 emerges, as well as for future threats. It is also important to note that widespread interruptions in the increasingly globalized supply chain, for both commercialized medicines and clinical trials materials, have underscored the need for initiatives to restore or establish domestic manufacturing within major markets.
Patient recruitment for clinical trials can be a major challenge even under the best of circumstances; however, this has been further complicated by the COVID-19 pandemic. New and evolving telemedicine and DTP approaches and e-tools may play roles in creating new recruitment opportunities, but it is critical to understand where to place the study based upon which countries have managed the crisis in the best possible way, while identifying the death rate per capita vs. the infection rate, and to evolve regulatory requirements to make the most out of these possibilities.
Demand has also increased to find ways to generate predictive models for pandemic environments that would enable companies to carry out accurate feasibility as to which countries would be the best options for clinical studies, synthesizing evolving analytical data about safety, supply chains, governmental restrictions, and the particular requirements of a given study protocol. SanaClis is closely monitoring the evolving pandemic situation in collaboration with its partners to collectively determine what innovative changes the clinical trials industry can take to best serve current patients and to prepare for the future, in addition to providing essential and expert assistance to multiple governments globally.
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
SanaClis remains one of the most recognized full-service CROs with integrated clinical supplies in the industry, offering a boutique, one-stop shop for sponsors and their clinical trials, which ultimately impacts the deliverables of their biopharma clients. SanaClis has all services in-house, including solely owned, state-of-the-art GMP/GDP-certified and compliant depots. SanaClis holds a near perfect track record of on-time delivery, with approximately 95% of projects delivered on or before the set timeframe and within budget. With such a commendable track record, SanaClis has established long-term relationships with both large pharma and biotechs across the world for their studies, building partnerships based on transparency, trust, and quality. Clients especially value the dedication of staff working on their projects in combination with a near-zero turnover rate on assigned projects: this is facilitated by the company’s strong focus on employees, offering a pleasant and healthy working environment and a wide range of company benefits.