Clinical Research Sites Discuss Moving Beyond COVID

After the chaos of the past year, many of us wonder which of the changes we’ve made to allow for remote work will continue and which will get tossed aside as the clinical research industry evolves. 

If you work at a study site, figuring out what technology to keep and what to discard probably lies near the top of your 2021 to-do list. 

As a site-first clinical research technology vendor, Florence has always cared deeply about the site experience. That’s why our VP of Marketing, Blake Adams, sat down to talk with Catherine Gregor, Director of Clinical Research Administration at Vanderbilt-Ingram Cancer Center, Casey Braddy, Assistant Director of Research Operations at the same location, Sara Guyler, Research Regulatory Services Manager at AdventHealth, and Stacie Rebar, Director of Clinical Research Operations at MultiCare Health System. 

In this interview excerpt, these clinical research experts talk about how COVID impacted their study sites and what technology they plan to keep using in the future. 

Check out our companion blog post and webinar if you want to hear about changes in technology from the sponsor and CRO perspective, and watch the complete webinar to hear more about the technological advancements Gregor, Braddy, Guyler, and Rebar discuss below.

Interviewer: What did the last year look like for your clinical research operations?

Catherine Gregor, Vanderbilt: The biggest change is that the majority of our non-clinical staff are now off site. We’ve moved all of our data, regulatory, quality, and finance staff to working remote…so we had to figure out workflows between clinical staff on site and staff off site. 

And (for workflows) the biggest change that we’ve made is obviously the implementation of Florence, which we initially brought in just to meet a regulatory need. But since that time, due to COVID and the quick need for more remote access, we’ve actually expanded it to multiple departments within the organization. 

 Casey Braddy, Vanderbilt: We decided to not only use Florence for regulatory because—for example, in December we had 2,500 e-signatures alone, and we had a four-day turnaround on those e-signatures, which is really great for us. 

So we decided to move it into a data implementation role, not only to expand on those signature abilities but to allow us to do remote monitoring in a way that is less time-intensive for our team. If we use Florence, it lets us give people access in a more comprehensive way but also not have to scan in documents manually every single time.

Gregor: And we’ve expanded it to some of our other administrative functions. Our compliance team currently uses Florence to route action plans and audit findings for signature and approval. And we’ve actually partnered with our contracts team to allow several documents to go through Florence for e-signature because they did not have an electronic signature solution. And the ability to route documents and sign them in a way that is compliant has really helped during COVID. 

Sara Guyler, AdventHealth: I think the main thing that happened was the change to this remote world. We changed to Florence at the end of 2019, so we were already on that path when COVID hit, thankfully…For the most part, we’re still not having on-site monitor visits, and that was a huge change for us because we need those visits to bill and get paid. 

And not being on site to connect with the study team or the doctors as we used to—you know, a face-to-face meeting turned into a Teams or a Zoom meeting. And for some people that’s great, for some people that’s a little harder to wrap their heads around. 

Stacie Rebar, MultiCare: I think the biggest thing is that so much of our staff has shifted to work remotely. We’re at about 18,000 people in our healthcare system, and I think something like 3,000-plus individuals are now fully remote, working from home on a permanent basis, which includes all of our regulatory, budgets, and contracts staff. 

We’re also keeping our staff pretty thin. We don’t ever want to risk our workforce. We’ve adjusted so that even those of us who are on-site staff, when we have administrative time, we’re doing that remotely where possible. 

Interviewer: What are some of the unexpected challenges that impacted your organization this year?

Rebar: Consenting. Trying to figure out the process of the best way to do it remotely…The other challenge is just overall patient engagement in trials. 

There are those sick patients that are already in the system. But when you’re talking extra visits or some of our pediatric populations, everybody’s trying to button down the hatches and stay closer to home. How do you explain coming into the site more often when people see that as a place they don’t want to go, because hospitals and clinics are where sick people are, or that’s what they presume? So that’s been a challenge. How do you lean into technology to still get the studies done but do it in a way that makes everybody feel safe and comfortable? 

Interviewer: Other than the Florence platform, what other technologies or processes have you deployed over the past year to mitigate some of the COVID disruptions?

Guyler: Outside of Florence and just doing remote meetings whenever we can, the big thing was e-consent. We didn’t have a way to do that remotely when COVID hit. We had quite a few COVID studies open and we couldn’t go into the room and consent those patients, for obvious reasons…So we had to work around and see okay, what can we do to address that urgent need in our current state? We ended up using Adobe Sign and for now, that’s how we’re doing e-consent. 

Rebar: We’ve done a lot through a secure photograph system for consenting. Our consenting process is we’ll get a paper consent form for the patient, I will have a conversation over the phone, and then we get secure photographs that we can upload into Florence. And then we do the signing piece in our EMR that we also upload into Florence, and we provide that to our monitors so that they can see those pieces remotely.

Interviewer: We’ve seen an explosion of remote monitoring over the past year. Could you talk more about that?

Rebar: I think initially we had monitors who were like “yeah, we’ll just push out our monitoring visits for a couple months” and we were able to very quickly say, “well, we have Florence. We can do this remotely through building shadow charts.” And after a few months, people got on board because you can’t not monitor something for a year. So we were able to upload our source data, our drug dispensation logs, our consent forms, anything that we needed to so that those monitoring visits could still happen pretty seamlessly. 

Guyler: I don’t anticipate a lot of the monitor visits that previously were on site going back to on site. You know, that’s a lot of cost on the monitor side and time and effort flying in. If we can do this remotely and monitors are getting what they need to review the study, that may be something that stays. I’m sure there will be some in-person visits like site selections, training. But anything that can be done remotely, I see that sticking around, because everyone who didn’t know if it would work is seeing that it has worked for the most part.

Discover More Changes Research Sites Will Carry into the Future

In the rest of our webinar, the panelists discuss remote monitoring, integrated eISFs, e-consent, and other technology they believe will shape the future of clinical trials. Download the full panel discussion here, and check out our complementary webinar to get the sponsors’ and CROs’ perspective on how clinical research will continue to evolve.