The Shift to Hybrid and Virtual Clinical Trials

During the regional lock-downs of the COVID-19 pandemic, telemedicine became a popular option for patients to see and interact with healthcare providers without visiting their offices. The initial motivation to move to telemedicine was to prevent the spread of COVID-19 and enhance patient safety. Since then, telemedicine and other tools have gained popularity and provided exceptional support for patients in a remote setting. 

In a parallel track, the conduct of virtual clinical trials has also become extremely popular. Before the pandemic, there was interest in exploring the possibility of virtual trials. However, the pandemic is what truly pushed research teams to “think outside the box” and make significant progress toward complete virtual trials. Site closures, quarantines, travel limitations, and supply chain issues for investigational products made it difficult for clinical trial teams to meet protocol-specified procedures such as protocol-mandated lab or diagnostic tests or healthcare visits.  

Academic institutions and clinical researchers around the world quickly pivoted and designed new ways to interact with clinical trial participants. New technologies emerged, and existing technologies were enhanced or used in new ways. The result was a renewed interest in improving the patient experience and helping research teams engage patients remotely. In March 2020, the US FDA released “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards.” The guidance was updated numerous times throughout the pandemic, with August 30, 2021, as the most recent update. 

Virtual Clinical Trials Today

Today, electronic data capture (EDC), wearables, and other devices for electronic patient-reported outcomes (ePRO), remote eConsent, and telehealth enable remote patient participation. However, some clinical trials in therapeutic areas such as oncology require periodic patient visits for imaging, biopsies, and other medical procedures that require specialized equipment or expertise. These clinical trials are typically designed as hybrid trials where some patient visits are conducted at a site facility, and some are via telehealth. A recent Science 37 Survey suggests that 77% of research executives expect to conduct clinical trials using remote patient monitoring, eConsent, ePros, telemedicine, wearable devices, and mobile nurses in the next 12 months. 

Clinical researchers hope that virtual trials will reduce the patient burden and potentially lead to the acquisition and retention of expanded trial populations that are more diverse. To ensure that clinical trial participants represent the patients that will use a medical product, many clinical trial teams seek participants from more diverse and inclusive populations. Virtual clinical trials may provide a mechanism to connect with previously underrepresented groups, including racial and ethnic minorities and people of different ages. 

The potential benefits of conducting virtual and hybrid trials for patients are significant. That doesn’t mean there aren’t challenges, especially for site teams who must learn new procedures and technologies used within the clinical trial ecosystem.

telemedicine appointment

Let Vitalief Help You Move Towards Virtual and Hybrid Clinical Trials

The pandemic truly motivated the clinical research industry to make significant strides in virtual clinical research. There is still a great deal to learn. But the industry has proven that open-mindedness, creative thinking, enabling technologies, and commitment, have enabled researchers and health authorities to pivot quickly and deliver innovative medicines to patients with unmet needs.

Not sure how to navigate your organization towards a virtual or hybrid clinical trial? Let Vitalief offer support and guidance to help your organization shift towards future clinical trials. Contact us today to learn more about our solutions and how we can assist with hiring the right staff, clinical trial support, processes, and more.

When Culture Drives Success

When Culture Drives Success

There are plenty of blogs and books about organizational culture and its impact on the success or failure of a company. Company culture impacts employees, management teams, partners, and clients. Peter Drucker famously said, “Culture eats strategy for breakfast.” David Cummings, Co-founder of Pardot, similarly advised, “Corporate culture is the only sustainable competitive advantage that is completely within the control of the entrepreneur. Develop a strong corporate culture first and foremost.”

The reason culture has such a powerful impact on an organization comes back to the organization’s most important “assets.” PEOPLE within a company define the culture; they decide whether to embrace it or not, whether to prioritize and promote it and how sustainable it is. You can’t have an organization or a culture without PEOPLE.

coworkers sitting in a circle with notepads and devices collaborating

Developing a unique culture that puts PEOPLE FIRST is challenging. Still, it can offer greater value to all stakeholders – employees, clients, and partners. A culture that is aligned with employee goals, wants, and needs is more apt to survive than one that prioritizes the owner’s well-being and discounts the well-being of the rest of the team. A culture that focuses on client satisfaction to the detriment of their team members might have temporary success but will be challenged by high turnover rates and low employee satisfaction.

The Vitalief team is spending time developing and defining our PEOPLE FIRST culture. Our team members support clinical trials in a variety of positions. We understand how vital PEOPLE are in clinical research. We extend our PEOPLE FIRST approach to include the patients who participate in clinical trials and the people who will use innovative therapies when they are available.

In creating this culture, we are learning a lot about workforce trends and how important flexibility is to so many team members. We are also learning that not everyone defines flexibility in the same way. We understand that people want professional development opportunities and want their contributions to be valued by the organization. Staffing shortages have created high demand for talent. Nobody wants to be treated like a commodity.

young professionals smiling inside an office

We won’t get everything right as we try to create a different experience for our team members. We will make mistakes along the way. We will learn from our mistakes and make sure that we actively listen and respond to our team members. We are creating a learning culture.

The way we see it, the world is changing, the workforce is changing, so corporate culture must change too. Companies are facing unprecedented challenges in the workplace because of the pandemic. Employees have shifted priorities to a “life-work” balance. Vitalief not only recognizes these shifting priorities, but we also embrace them. We want to be transformational leaders in clinical trial solutions. We can achieve this by creating a different type of company and a different type of culture.

We are embarking on this journey with shared goals and a mindset that values collaboration and recognizes that each team member brings unique skills, training, and experiences to the table. We value these, and in return, we want to make sure we present opportunities that help them sharpen these skills and develop new ones.

We honestly believe that this culture is our key to success. It isn’t just a social experiment. It’s our way of working. It’s a new way of working.

We are creating the culture in which we want to work.
Our PEOPLE FIRST culture drives our success.
If our PEOPLE FIRST culture sounds interesting to you, let’s talk.

-David Moore

Contact Us to Learn more!