The COVID-19 pandemic has touched nearly every part of our lives, and the universal impact has been astounding. The result has undoubtedly created a shock across Clinical Trials teams around the globe. Research teams are now facing new, often difficult decisions regarding the progress of their studies and the safety of their team members.

We acknowledge that this is impacting our field and our partners, but we are also keenly aware that there is an opportunity for innovation! To serve our community, we have reached out to four thought leaders in the industry to see how they have taken to adapting to Clinical Trial research in the age of COVID-19.

These organizations are leveraging remote technology to mitigate disruptions to their systems, policies, and processes necessary to continue in safe, regulated studies.

Who is leading the conversation?

is serving communities across Washington State as not-for-profit health care organization.

watch their video interview here.

Stacie Rebar

 Director of Research Operations

Jessica Rowden

Regulatory Affairs

Vanderbilt-Ingram Cancer Center
has eight innovative research programs committed solely to the discovery of the prevention and diagnoses of cancer.

watch their video interview here.

Cancer Center 
Catherine Gregor

Director of Clinical
Research Administration

Cancer Center 

Casey Braddy

Manager of Quality Assurance
and Data

The University of Arizona Cancer Center
is engaging clinical scientists in over 200 trials as an innovative force in cancer research.

watch their video interview here.

The University of
Arizona Cancer Center

Chad Adams

Associate Director of Clinical
Research Administration

is responsible for over 200 clinical trials working to personalize care for cancer, heart disease, and brain and spine injuries.

watch their interview video here.

Dr. Aurea Flores

Director of Research Quality, Regulatory and Compliance

Each of these organizations harnesses Florence eBinders to manage their operations. Additionally, they serve on the Florence Executive Customer Advisory Board who provide input and guidance on the Florence strategy to the advancement of research and technology.

Florence: How has your implementation of Florence eBinders™ and other digital platforms over the past few years helped facilitate or mitigate disruptions caused by COVID-19? How has eBinders impacted remote work and monitor visits?

Vanderbilt-Ingram CC:  We were knee-deep in preparations for Florence, including the implementation process. The preparation helped us move quickly to identify which studies to transfer to an eRegulatory binder. COVID-19 is continuing to push the project forward. From a Coordinating Center view, we have also been able to route regulatory documents via electronic means rather than having to FedEx things or have people in the office.

MultiCare: Within 48hrs we shifted from normal on-site work to almost complete remote work. The shift would not have been successful without Florence. At the same time, we were no longer allowed to have visitors come on site which would have put a halt to physical monitor visits. Because we already had processes in place and actually managing all of our active trials in Florence, the transition to remote work was really seamless and remote access via Florence allowed us to maintain monitor visits.

Additionally, we are very paper source oriented and a lot of our sponsors are unable to receive source through email, so at least having Florence we have a platform we are able to upload to and have a restricted source. There have been a few ideas that we had for Florence and now is the time to move forward with them.

Arizona Cancer Center: Unfortunately, we were in the process of moving our processes into Florence when COVID-19 took place. Since we are not fully implemented, we’ve had to stop most of our operations. If we had started earlier, we would not have had to halt remote monitoring or the majority of our operations. We would have been protected.

We are pioneering digital collaboration, which is critical to research organizations for 1000 reasons. Our use of Florence is creating a more fluid enterprise by allowing us to extend our arms to smaller regional hospitals that can participate in research without having the infrastructure locally.

HonorHealth: We’ve been transitioning to remote work before COVID-19 due to concerns from sponsors and CROs who wanted to complete everything remotely. Reducing the number of on-site visits was a big focus before COVID-19 and has turned out to be very beneficial for us now.

Florence: How do you see the industry shifting over the next 3-5 years in terms of remote management, remote collaboration, and remote work?

MultiCare: I think of Monitor visits. The resources, cost, and burnout you see with monitors having to travel all of the time have a real impact. Right now, we are all engaged in a big experiment by continuing to have these visits remotely.

We’ve historically held on to old processes for too long. If we can provide photographic documentation of all of our equipment and virtually walk through the monitor questions, it makes us wonder if on-site visits are necessary. Do monitors really need to come on-site? Can remote work decrease timelines, bring the cost of trials down, and potentially provide a deeper monitor group by preventing burnout? You could really see a significant impact.

HonorHealth: The effects of the current situation and the need of remote technology will trickle into the future. However, we need to think about the future regardless of the current situation. How do we better serve our long-distance patients? We still want to provide care to these patients and allow them to participate in studies. How can we better utilize technology to facilitate this?

Vanderbilt-Ingram CC: Prior to us all being remote, some of our staff were spending an hour a day on shuttles just to move paper. Now we’re seeing what we can do electronically and push ourselves to gain time back, be more productive, and think about metrics to actually measure what we’re doing. We’re behind in terms of utilizing technology for remote work capability.

This situation has forced us to say, “Hey there is a lot of work that can be done well off-site and we can expand our resources without expanding physical footprint.” The other piece that shifted very rapidly is that we are switching as many patients as we can to telehealth visits which normally they would have to have somebody touch and feel; I think this is going to be a long-standing change where we look at what we need patients to come to health facilities for and how that impacts care once we get past this barrier.

Arizona CC: Having access quicker to the data…How do we collect the data we want as quickly and as efficiently as we can? Sponsors and CROs will see increased integration with their sites and access data faster to help find solutions. In our long-term vision, we want to see an utterly fluid operation for research that is not dependent on physical location.

Florence: Do you have any advice, tips, or strategies for people in your shoes who don’t have a system like eBinders or any other digital system in place? How do they go about maximizing their research and begin thinking about future investments?

MultiCare: Well, you look at how many industries will be impacted dramatically, like restaurants and gyms. The medical system will continue moving forward. If we were looking at having to put a full stop to clinical research due to the lack of remote work capabilities, we would incur a substantial monthly cost. I can’t imagine going through this a year ago without Florence.

Now having Florence and all the capabilities we’ve maintained, the cost more than justifies itself. Our advice would be to not think of remote work as a temporary situation. Think of this as where the future is going, and the use of eReg or eSignatures is here to stay.

Arizona CC: Adopting a digital system provides enormous stability for operations and data research to maintain a central source of truth for clinical trials. Experiencing another pandemic in our lifetime is almost zero percent. Still, there are many other outside influences other than the current pandemic that has the potential to disrupt operations.

Implementing a digital system serves as an essential mitigation factor for the future. The whole value of a CTMS is to have a central recognized source of truth for the trial. When that expands to other research operations, like shadow charts, binders, and pharmacy documentation, we create an enormous amount of stability for the operations in our data research.

HonorHealth: On the operations side, what we have done is to try to reduce the number of personnel on-site. We know our studies, and we know who’s coming in terms of patients. We have ensured that one person who’s very knowledgeable about the study is on-site to ensure the visits go well. We are also moving as much as we can to phone visits to align with FDA guidance. In addition, it helps to think outside of the box as much as possible.

Know what you have to work with and what you need to implement to put new systems or processes into effect. You have to be able to work together as a team to get the job done.

Vanderbilt-Ingram CC: Ask yourself a series of questions that lead to determining what processes should be in place. Take an inventory.

What do we have to do on-site? How can we stretch these activities? Do we have to have a university computer, or can someone remote in from a personal computer at home? How do we check-in? What are the performance metrics? How do I make sure people are working but are also supported? How do we replace those necessary, informal interactions, and help people not feel isolated?

Florence: Everyone in this industry is experiencing similar obstacles and frustrations during this time. Can you share any further tips or final thoughts for colleagues now or in the future?

MultiCare: Look and plan ten steps ahead. Remote work isn’t going to be a temporary shift. This situation has a massive impact, but we’ve seen storms before that have shutdown regions. What does it look like when systems and processes are being held up in paper form? What do cloud-based systems look like, that allow you to move people physically, but still keep an aspect of your business running? That’s where we’re trying to take our approach.

Arizona CC: The more sponsors and sites can interact transparently and efficiently with online operations, the more costs will drop, and efficiency will be improved. It all comes down to the willingness of both parties to become interoperable and recognize that there is a universal value.

Digital collaboration brings about so much improvement; it is well worth every dollar that you invest in it.

HonorHealth:  The key to this is to remember it takes a village to conduct a clinical trial. Every institution has different challenges and infrastructures, so it is about coming to the table and discussing what you have available to you and how to make things happen. 

Vanderbilt-Ingram CC: Learn what you really have to do on-site and find ways to stretch that into remote work. Put processes in place for what you don’t have to do on-site. It will benefit you in times of need.

Listen to your staff! A lot of great ideas come from the entire team. Tap into your talent as best as you can. Stay flexible, focus on patient safety, and the rest will work itself out!

After hearing from leading professionals across the industry on their approach to mitigating disruptions during COVID-19, it is your turn to build a plan for your organization to navigate these new and unfamiliar circumstances. We created a guide based off of customer insights and industry shifts to help you create a long-term plan for remote clinical trial progress, access and monitoring. You can download the step-by-step guide here, no email or information required.