podcast_Proxima Clinical Research

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst medical device companies worldwide. Are there creative ways to stay on track while ensuring the safety of those involved? 

In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Regulatory Affairs Consultant, and Stephanie Mull, Director of Clinical Project Management, from Proxima Clinical Research (CRO).

Together, they discuss the challenges and concerns for medical device companies conducting clinical trials during the COVID-19 pandemic and offers new perspectives for listeners to consider in terms of potential efficiencies and cost savings to gain.

 

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Some highlights of this episode include:

  • Challenges related to COVID include sites suspending operations of clinical trials, and restricting CROs and subjects from traveling or coming to sites.
  • Some medical device spaces, products, and technologies have been impacted more than others. It’s more difficult than normal, but not impossible, to perform elective procedures, especially in hospitals. 
  • Widespread, Worldwide: Clinical trials continue to be conducted in the United States, but in a different atmosphere with changes compared to other areas that have completely suspended trials temporarily, such as Europe and China.
  • Subject safety is the primary issue to be considered and evaluated related to risks, reasons, and causes to suspend clinical trials.
  • Staff Availability: Sites must have adequate and properly qualified and trained staff to conduct and provide oversight to continue clinical trials safely.
  • Electronic data capture (EDC) versus paper management of sites and studies for clinical trials is a more controllable way to document and collect data from patient monitoring and different types of visits. 
  • Protocol deviations and amendments should be approved by the FDA before proceeding with a clinical trial. Subject safety, again, is always the first priority. 
  • Human Factors: Changes should make medical device and clinical trial design more usable, such as patient monitoring from a safe distance due to COVID.

 

Links:

Proxima Clinical Research

Emergency Use Authorization (EUA) 

National Institutes of Health (NIH)

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable Quotes from this episode:

“A lot of the trials have been stalled, and it’s hard to get sites up and running.” Isabella Schmitt

“We’re seeing a lot of issues with just sites not being able to operate normally, and then sponsors and CROs not being able to operate normally either.” Stephanie Mull

“Even if the trials are running, there are changes being made. People are moving to more remote monitoring or virtual visits. Things like that are occurring more.” Isabella Schmitt

“The first thing is the subject safety. That’s always the paramount issue in a clinical trial, whether there’s COVID or not.” Stephanie Mull


Transcript:

Announcer: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: On this episode of the Global Medical Device podcast, I had a chance to chat with Isabella Schmidt and Stephanie Mull from Proxima Clinical Research. And the topic that we dove into is conducting clinical trials during COVID. So, enjoy this episode of the Global Medical Device podcast. Hello, and welcome to another exciting episode of the Global Medical Device podcast. This is your host and the founder of Greenlight Guru, Jon Speer. And as we're talking about this, and I'm sure by the time this goes live, it's still going to be the case. We're all still in this pandemic situation in the world. I think we're all trying to figure out specifically from a medical device industry standpoint, what the impact is. I know there's been a lot of movement on the emergency use authorization. I've heard some stories from other companies that this has caused some challenges and delays. And then some of the challenges and delays have been in their clinical studies, which is unfortunate because they're developing other very meaningful products and technologies. But I think we're starting to figure out ways to navigate this. And the good news is I got some experts joining us today on the Global Medical Device podcast. We have Isabella Schmidt. Isabella's been a guest before. Isabella is with Proxima Clinical Research, and she is a regulatory affairs consultant. And joining her as one of her colleagues at Proxima is Stephanie Mull. Stephanie is the director of clinical project management. Ladies, welcome.

Stephanie Mull: Thank you.

Isabella Schmidt: Thanks for having us.

Stephanie Mull: Glad to be here.

Jon Speer: Absolutely. So clinical trials, this is one of your areas of domain expertise. And I guess before we dive too deep in the subject, this current pandemic, it's caused some chaos, I can imagine. Right?

Stephanie Mull: Yes.

Isabella Schmidt: Yes. A lot of the trials have been stalled, and it's hard to get sites up and running. And Stephanie can probably talk to you a lot of the details of inaudible with that. But yes, it's been crazy, especially outside the US too.

Jon Speer: Yeah.

Stephanie Mull: I think we've seen that. Sites have been suspending their operations of clinical trials. They're restricting visitors coming in. So CRAs can't come on site. Several of the CRAs are not traveling just for health reasons as well. Subjects aren't able to come in as well. So we're seeing a lot of issues with just sites not being able to operate normally. And then sponsors and CROs not being able to operate normally either.

Jon Speer: Right. I guess I'm curious. Are there some device spaces or products and technologies that, in your opinion, have been impacted more than others? Have you any thoughts about that?

Isabella Schmidt: Usually, if it's an elective thing, those are pretty impacted. Especially if it's an elective thing that's involved with the hospital, because the hospitals are a bit overloaded. And a lot of medical device studies are in hospitals, university hospitals. And so they get pretty impacted in specific areas too. Like Houston right now is a bit overloaded with cases. So it's sometimes difficult to get some of the sites up and running here. And I'd say, across the board, I think it's been more difficult than normal, but not impossible. But elective procedures have had more of a halt to them. I don't know. Stephanie, do you have any other ones?

Stephanie Mull: Yeah, we've seen that. We've had a few of our trials that have involved elective procedures that have had to be delayed for several months, because the hospitals were wanting to save bed space. So, those procedures could not continue.

Jon Speer: And Isabelle, you talked about Houston being maybe a little bit impacted because of availability, and spikes, and things of that nature. And you talked a little bit about the global phenomenon that we're seeing too. Are there areas of the world where we're starting to see an increase of clinical studies picked back up? Is there anything light at the end of the tunnel in a good way?

Isabella Schmidt: I can tell you, I guess, the reverse answer to that. Not too long ago, and everything's changing so quickly-

Jon Speer: I know. It's so fluid.

Isabella Schmidt: ...so it's hard to say exactly. But not too long ago, a client in Finland asked me when we would be able to run clinical trials again. This might have been maybe a month ago. So they're obviously closed too, for clinical trials there. And in the United States, we're still running the trials. And we are still running the trials. It's just in a different atmosphere here now. And I think that that's the case probably in a lot of the places that are impacted, like Europe. China's pretty resolved now, I think at least. So, that impact has been kind of pretty widespread, where even if the trials are running, there are changes being made. People are moving to more remote monitoring or virtual visit. Things like that are occurring more. And so that does make the sites shift how they practice. And so that can lead to certain complications and considerations for some sponsors, and also for the sites.

Jon Speer: And Stephanie, you shared a couple of things a moment ago about some of the causes that can suspend a study. Do you mind maybe elaborating on those just a little bit?

Stephanie Mull: Sure. You know, I think the first thing is the subject safety. That's always the paramount issue in a clinical trial, whether there's COVID or not. Right? We have to always make sure that whatever we're doing, the subject safety is the first thing that we're taking into consideration. So as trials have been met with the impact of COVID, the sites and the sponsor both have to stop and take a look and say," Is what my trial all about, can I continue going forward in this environment and still ask the subject to participate and come in? And are they going to be put at risk?" And so you really have to stop and evaluate all of that. And you have to evaluate both sides of it. Is there a risk for them coming in and contracting COVID just by being out and about? Right? Or is there an alternate safety risk of them not being seen and then continuing on without being seen in the study with their investigational product, whatever that may be? So you have to look at both sides of it, and so really have to weigh, where do I need to ensure that the subject is being safely monitored? And like Isabella was saying, that's where the new, because of those risks on both sides, we don't want to put the subject in undue risk by asking them to come in. But yet I can't suspend. I may not be able to for my particular trials to spend all visits for that subject because of the particular investigational product they're receiving, I need to follow up for safety reasons. So that's where we really have to look at the trial, and pivot with the site and look at, what can I do with the site to make sure that the subject safety is going to be of utmost importance going forward? A couple of other things: just the availability of the staff. A lot of clinics had to shut down their staff. Having them come in, that's also a risk to their safety. So one of the things about starting up a clinical trial that you always have to ask is, does the PI have adequate staff to run the trial? And can he or she provide adequate oversight? And if you don't have staff any longer, then you can't fulfill that requirement. And your staff, if you just have one or two staff left that can work on the trial, are they also adequately trained? So, there's a lot of questions you have to ask as you're determining all of the risks. And then, what are the choices that you want to make for how you can continue the trial safely?

Jon Speer: Those are really good points. I guess, starting off this conversation naively, I was thinking," Oh, well, it sucks that I was planning to do a clinical study and then something happens, and I can't do this, and it's delayed." But I totally forgot about the studies that were already in progress. Right? This is creating probably a lot of concern for folks.

Isabella Schmidt: Yeah. And having to... I guess there's also, you set up a study in a certain way, and a site as well. And mostly, everybody wants to... Going electronic is usually the way to do things now. Electronic as much as possible. You have audit trails and all that, and so it's way more controlled than if you do paper. But if you're trying to do something on a pretty lean budget, sometimes sponsors will still do paper studies. Papers studies are pretty hard if you can't go to the sites to do the clinical monitoring, that you normally would be able to go there. And so then you have this complication of, do you switch to electronic? And what does that look like? And then if you're switching to electronic, you have to find your EDC system, and then you have to make sure that your EDC system is Part 11 compliant, and then all the signatures are Part 11 compliant. And so you didn't thought of this. Like you fall down a rabbit hole, I guess, into all of the changes that you have to undergo, and making sure that you're still collecting and monitoring the data as much as you possibly can. Because FDA still wants you to do that. And if you're deviating from either monitoring or patient visit protocol deviation, you have to document all of those. And FDA is aware that with COVID, that'll happen more, because everything's so unstable right now. But they still want you to keep track of that, so that when you do go with your submission to FDA, they understand what happened. And then if you get a site audit, that's also documented there as well. And so with all that documentation, that helps address any variability that there might be in your data. So if you have patient windows, often in clinical trials, patients have visit windows. And so it may be difficult for patients to get to sites in those windows. And so then, you have a protocol deviation there. If it's a protocol deviation for safety, always the safety, like Stephanie was saying, of the patients is paramount. And so you make the choice to have that protocol deviation. But FDA, normally, you have to get a protocol amendment approved. And so FDA typically will want you to get that protocol amendment approved before you start executing on that amendment. So if you're changing visit windows, or you're changing from in- person visits to virtual visits, that's something that would probably require a protocol amendment. And normally, you get that approved through the IRB and all that, first. But in this particular case, if it's a safety related issue, they would just want you to have a deviation. And you'd start doing that, and then you have to inform them after you started. For IDEs, they want it within five days. But within five days, they're also understanding about that. So if you can't do have an inaudible on the sponsor side, working on your study, it may be difficult for you to report all of the deviations, and amendments, and things like that within five days.

Jon Speer: Yeah. I mean, obviously, this is the world that you both live in. And I guess I never thought about it. I assume protocol deviations and amendments, these happens on a normal basis, right?

Stephanie Mull: Yeah. I mean, just as you're going along in the trial, deviations happen. Patients don't show up when they're supposed to, assessments are out of window a lot of times. And you just document it. And if it's a minor deviation, you keep track of that. Major deviations obviously need to be reported appropriately to the IRB and sponsor. But yes, in this environment, there's a lot more deviations going on because of just what's happening across the board with the pandemic. And ideally, yes, you would like to submit an amendment first to the FDA before you implement anything. But again, as Isabella said, because of subject safety, you want to make sure that you're looking at that first, and implementing any changes. And then you can notify the FDA after that.

Jon Speer: Yeah. It seems to me, based on the two of you describing this, that the number of deviations is probably significantly higher. And what that says to me, Isabella, you mentioned EDC. I'll just elaborate. I assume that means electronic document control. But it seems to me that that document control and document management is probably a core competency for anybody conducting a trial to begin with. But now this is exaggerated. This probably puts a lot more emphasis on good documentation practices.

Isabella Schmidt: Yeah. It stands for electronic data capture.

Jon Speer: Oh! See? I didn't even have it right.

Jon Speer: Well, I'm glad I said something then. That's good. You know-

Isabella Schmidt: Just our own terms, like everybody knows what they mean. Well, I'm the acronym girl now.

Jon Speer: Well, it's an acronym- rich industry. And there's segments where the acronyms are different than in other segments. So I'm glad you elaborated on that. And the subject visits, that seems like a really important thing. And I could speculate, but I got to imagine there's probably some best practices that you have seen and might be able to suggest to folks. How do you handle virtual visits? Any best tips or pro tips you could suggest?

Stephanie Mull: Sure. Subjects can have phone visits. That would be one of the first things. That's probably one of the easiest ones to implement. And phone visits are oftentimes routine parts of clinical trials anyway, especially in maybe some longterm followup studies, where you just want to call subjects and check on them for adverse events and any kind of meds, things like that. But if you're switching from what would normally be an in- person visit to a phone visit, there might be some things that you can't accommodate. You can't check somebody's vitals while they're on the phone. So you could potentially still conduct a phone visit and ensure that the subject is safe. I mean, are there any adverse events that are happening? You can check on them with any of their investigational product and how that's going. But you will, like we talked about, probably have to write deviations for the things that you couldn't do because you weren't in person. Another option that we've seen sites doing is switching to virtual visits at Teladoc. So oftentimes, a lot of sites already have started to implement those just in their routine practice, not necessarily for research. So if a site already has that up and running and they can utilize that, one thing I would just say is that switching from an in- person to a tele visit does require some training. And I think we would need to document that, that this site does understand how to conduct a visit over video, and ensuring that there's the proper controls in place. So, you just need to think about that and how will you document the training that the staff have, to ensure that they know how to conduct those visits. But those are the two types of visits that could still continue from the site and the subject. The other types of visits that have been going remotely are your monitoring visits. And I think we've touched on that a little bit before. So we've seen, typically, when you start a trial, you do a qualification visit of a site, where you go onsite and you check out, do they have the necessary space? Do they have the staff? You actually see the people in person. You see where they're going to store the equipment. And you can check all that out. We're not in this environment. Most of the sites are not allowing onsite outside visitors. Some are starting to, but a lot of the larger institutions still are not. And then when you have to initiate a site and train them, oftentimes, we do that onsite as well. And again, we're having to be creative and come up with ways of how we can train sites to conduct the trial appropriately, not being in person with them. We had one interesting scenario where a site had to be trained on a device. We couldn't do it in a remote fashion. They had to actually have hands- on experience with the device. And so we rented a space at a local hotel right across the street from the institution. And so the staff could come to that hotel and maintain social distancing, and wear masks, and be safe, but could have that hands- on training with the device. And we could still accomplish that even though we weren't necessarily allowed onto the institution itself.

Jon Speer: Oh, wow. That sounds like you were being creative in a productive way. So, good on you. Folks, I want to remind you, I'm talking to Stephanie Mull and Isabella Schmidt. Both these ladies are with Proxima Clinical Research. They do a ton of work, certainly in clinical, but also in regulatory front. I would encourage you to learn a ton more about Proxima Clinical Research by visiting their website. It's www.ProximaCRO.com. Stephanie, you talked about, a moment ago, doing some of the virtual visits. And you said something I was curious about, about vital signs, where a patient needs vital sign checks and things like that. I can imagine a lot of patients who are in these studies, they don't have blood pressure monitors and things of that nature. So are you seeing those patients be issued in- home health devices to be able to do that?

Stephanie Mull: That is something that could be considered. I think a lot of the options that are out there to do, you just have to take into consideration the time and effort that it requires to get those things procured, and then shipped to sites to give to patients. And sometimes, and then documenting all of that change and how it's going to be managed. And so assessing that timeline versus the timeline of COVID overall that we don't really know, and making those assessments to say," Okay, we're going to do this kind of creative, innovative thing a little bit differently." But we have to make sure we document all of it and we're changing if we have to write up any plans or amendments for how this is going to be handled and make sure all that's in place. And then you can move forward with it. So yeah, I mean, I think, there's things like that. There's also, site subjects could go potentially, if they need to get their labs and they can't go into the site but there's a local lab that's available, they could go there to get their labs. Provided that the labs are standard that would be drawn, that are available at any local lab. Something like that. You could do that in an instance as well. And the FDA guidance allows for something like that. So there's things that can be done. And I think you just have to take a look at your study, and the scale of your study, and the number of patients impacted and the sites. And maybe not every single site has that option either. So it's a little bit of a nuance of what's available at each site, what options there are, and then looking across the study as a whole, and ensuring subject safety first and foremost, but then data integrity and what's going to happen at the end of the study with the data, and thinking about that too.

Jon Speer: I know in general, the topic of human factors is a big area of focus for medical device companies. And it seems like with all of these nuances that this pandemic is causing from a clinical trial perspective, that it might even put even more emphasis on the human factor side of things. Do you have any context, or anecdotes, or things, or tips, or pointers that you want to share with folks?

Isabella Schmidt: Actually, Stephanie and I had a conversation before this conversation. One of the topics that we talked about, it wasn't necessarily a huge factor, but it was just about changes to device design, regardless of human factors. There are other reasons to make them a little bit more of getting to human factors that's usable. And the COVID, and what does that mean if you use for different personnel, maybe. Would be a human factor kind of thing, but also the ability for remote devices. Right? I think it's coming to be a bit more important for wearables to your point about tracking vital signs even outside of clinical trials. Just tracking vital signs in normal clinical space is becoming really important. And being able to do that from a safe distance is obviously better than sticking a thermometer in someone's mouth. So I think I don't know that I would have a specific example of someone doing something particularly interesting with human factors because of COVID, but there are obviously a lot of pivots. Not only with design, but with companies. You have a device who could utilize that design for COVID, who are maybe not pivoting entirely, but they're switching their focus for a little bit to, as you mentioned before, an EUA. So we've seen a lot of that. A lot of EUAs coming out of especially diagnostics companies to maybe have a platform technology that they can modify a bit to be COVID- related. And then to your usability point, I'm just throwing this out there. But if you're doing like a home use case, that's a whole different ball game diagnostics than it is if you're doing a clinical study. Usability becomes really important for home use diagnostics.

Jon Speer: Yeah. And I think I read or heard something recently where, I think, it's NIH has this program and I don't have all the details behind it, so forgive me for that. But maybe this a jog of some memory cells on your end, but there's some program at NIH level and there's a significant amount of funding. My number is probably off, but it's something like$ 2 billion or something as being allocated to companies for, I think, some sort of COVID diagnostic tests or something along those lines. Is anything that I'm saying ring a bell with either of you? Have you heard of this thing?

Jon Speer: Forgive me. I'll look it up. But anyway, there is a question here. I'll get to that. It triggered a thought. I think a lot of the people or companies that are diving into this program, some of them are new to med device, some of them are not new to med device. But just the notion of it being a diagnostic test says to me," Oh, wow. There's going to be some sort of clinical component to this." It seems like understanding how to navigate clinicals of this environment is really important. So assuming some of those folks might be listening, do you have any key tips or pointers on what folks should do? I mean, I know they should call Proxima CRO, but aside from that, any practical advice?

Isabella Schmidt: Specifically for diagnostics?

Jon Speer: No, it doesn't have to be just for diagnostics. I'm just saying in general. I mean, I know there's a lot of folks who are jumping in to try to develop some sort of diagnostic or test or-

Isabella Schmidt: Just someone who doesn't have medical device in the past? Like definitely from a different industry?

Jon Speer: Yeah. Right. Right.

Isabella Schmidt: I think the biggest thing for them to be aware of is that if they're coming from an unregulated industry, they're going to be... I've seen this. They are going to be a little shocked about what it's like to be in a regulated industry. So beyond, I guess if they're coming from not a medical device perspective, they've never done a clinical trial before so everything will be new to them on that front that they won't really have any comparison to make, the clinical trials, they're heavily regulated. And even when you have an EUA, you still have to have a lot of procedures in place to do complaint handling and things like that. So I would say, be aware that taking on... And I'm not discouraging them by any means, but they should just be aware that taking on something in the healthcare industry is a heavier lift than they may be used to in some of the other industries. Particularly like consumer electronics and things like that. And there's just a change in the mentality that you have to live by in the medical products industry. And I've seen companies coming like saying John from consumer electronics and aerospace, and they're coming up with virtually doing more than the lighter side of things. But a lot of people are doing face masks, which are a little bit less of a heavy lift than some of the other EUA products, but still different. And so I would just say, the main thing I would say across the board, not just with clinicals but across the board, is to be aware that there are regulations surrounding these products. crosstalk

Jon Speer: Yeah. And I'm sure the Proxima team is more than willing to have conversations with us folks, and try to give them a little bit of education on the things they should be focused on from a clinical perspective. Right?

Isabella Schmidt: Right. Yeah.

Jon Speer: Yeah.

Isabella Schmidt: Stephanie, do you have anything to add to the clinical concerns?

Stephanie Mull: Yeah, I was just going to say, the only other thing I was just going to add to that is if somebody is in the process of maybe they've already crossed over and said I'm ready to start a clinical trial, and they're kind of on that cusp of thinking about what they're going to do, I guess I would say that feasibility and talking to the sites at this point is really important. What one site has, and the process and the procedures they have in place for how they're handling COVID and patient visits and new trials, might be very different than another site. Especially when it comes to like academic centers versus community- based versus research standalone sites. I guess I would just encourage those folks that are going to be starting a new trial to have conversations and ask the questions of, what procedures do you have in place for COVID? How are you operating right now? How are you doing patient visits? Understand what the site has for procedure in place. And then you can get a broad landscape. Call five of your sites that you want to participate. Talk to them, understand the process. What are they allowing? What are they not allowing? One of the things, and maybe we will touch on this in a little bit, but for remote monitoring, it's really great if a site can give you access to their EMR remotely. That makes life really easy for monitoring the data. So there's still things you have to do to cover your bases and all of that, but it's much easier if a site can transition from having in- person monitoring visits to remote- monitoring visits that they can give you access to the EMR. And so I guess I would just encourage anybody that's new out there to, again, qualify your sites, talk to them, understand where they're at, what procedures do they have in place, and how are they operating at this current time.

Jon Speer: Yeah, that's good advice.

Isabella Schmidt: Yeah.

Jon Speer: Yeah, go ahead.

Isabella Schmidt: One thing I would say, I guess this for people who may be going into their first clinical venture, is that common lingo we're using may not be familiar to them. And they might not even know what monitoring means. Essentially, monitoring is when you have a qualified person. And qualified would be someone trained and who knows how to do clinical monitoring, go to a site or remotely get information from a site that looks at their" source data", which is essentially usually the identified patient record, to see particular interesting things that you're collecting for the site. So usually, you'll have something called a case report form, where you collect a bunch of data that is relevant to your study. And you need to usually verify that information in your case report form which can be in the form of an EDC, against the source data at the site, to make sure that it's accurate. So that's one thing. And then you'll also go to the site to check some things, or remotely inaudible the site to check for things like protocol deviations. A patient come outside of a window that you weren't expecting. So, that's all from the clinical monitoring thing. It's having some tool over the study, and making sure that the study is also progressing at the pace that it should be moving along. And EMR is electronic medical records too. That's another acronym that we threw out there. So, I don't know. Have I covered all of the basics there Stephanie? Did I miss.

Stephanie Mull: You got this. Great job!

Jon Speer: I'm speculating a little bit, or maybe I'm going to ask you to speculate a little bit. Of course, none of us have any idea how long this situation is going to be the new normal. But at the same time, we know it is the current normal. So do you see this kind of shaping the future of clinical trial design? I mean, the process behind it and how to do it? And again, I'm asking you to speculate. I know quality and regulatory people don't like to speculate a lot of times, so I might be making you a little uncomfortable with that question.

Isabella Schmidt: I don't mind speculating. So I would say, and again, Stephanie can disagree with me on the speculation, but I would say that I think as an industry, we're trying to switch more to electronically doing things as much as possible anywhere, and reducing the" monitoring burden". So we're moving towards risk- based monitoring, and remote monitoring. And we're moving from paper inaudible in the past to all electronic data capture systems. So I would say that we're in that shift anyway. So I would say this is just giving us a little kick in the butt to get a little bit faster with it.

Jon Speer: That's interesting.

Stephanie Mull: Yeah. I would totally agree with you, Isabella. I think some of the areas that maybe people have kind of dipped their toe in the water in the past, and some sponsors were doing electronic things. I think we're going to see a lot more people pushing forward into being as much electronic across the board for documentation and record- keeping and things like that. Sites have to keep a regulatory file for on- site for any trial that they initiate, and that contains all of the required FDA documents and essential documents that they need. And so oftentimes, that's been in paper. And I'm seeing a lot of sites starting to push now into having electronic ways of keeping that. So, I think not only on the site side, but on the sponsor side and the CRO side, pushing a lot more forward into as much electronic means as possible. I think doing data capture through electronic means. The EDC electronic data capture and electronic case report forms, I think that's been around for a good long while. And a lot of trials have been in that method, but I think some of the other ways of doing the monitoring and keeping your records and things like that in electronic means, is where we're going to see some of the changes as well. And I think we're going to see some cost savings as well, in that, if we can complete more visits remotely. And on more of a risk- based approach, you don't have to send a person to the site to check their data and monitor their data. You can do that remotely. So you save travel costs, and you save the time that they're in between. So I think there's hopefully going to be some efficiency and cost- savings that we'll see out of all of that.

Jon Speer: It sounded like a silver lining to me. Right?

Stephanie Mull: It only takes a pandemic to have a sun ray?

Jon Speer: Well, it's something that we've seen and heard a lot from Greenlight customers, that so much of the medical device industry across the board, regardless of functional discipline, has been probably too heavily reliant on paper full stop. And what we've been hearing from our customers, because Greenlight is a SAS platform for managing design and development, and quality events, and document management, change management, all the things that you would fit underneath your quality management system, that Greenlight it's actually enabling them to get work done in this current environment. Because everybody's remote. So, maybe that is the silver lining, that this is going to improve best practices. Because it is a little crazy to think about in 2020, how much we as an industry still rely on paper.

Isabella Schmidt: Yes.

Stephanie Mull: That's very true.

Isabella Schmidt: I totally agree with that. You guys should add inaudible to your agreement system. And then people can hold their inaudible meetings and stuff through the software. [crosstalk 00:35:14].

Jon Speer: Maybe like a Zoom integration or something? That's not a bad idea, actually. Yeah, I don't... I'll actually Log that. It's an interesting one. So I'll capture that as a feature request.

Isabella Schmidt: We'll start making you billions of dollars I would say.

Jon Speer: Yeah. Let's say, do the residual. Yeah, for sure.

Isabella Schmidt: Every inaudible can hear.

Jon Speer: We'll just call it the Isabella feature. We'll name it to... So, it could be good, it could be bad. I guess that's worth the risk. All right. Ladies, to kind of wrap things up today, any other key points, tips, gotchas? Anything else come to mind on this topic of clinical trials during COVID, that we haven't talked about today, that you think is really important to share?

Stephanie Mull: I would just say that whatever you do to change things to respond to COVID in your trial, especially if you're in the midst of the trial, is that you document it. And that's the big thing in our industry. If it's not documented, it wasn't done. And so I think, whether it's a deviation after the fact or updating your plans that govern how you're going to run the trial, your monitoring plan, your project management plan, your communication plan, your whatever plan you might have for the trial, ensure that they're updated with all of the changes that you're making. Again, protocol updates, all of that, and that you're documenting what you're doing to protect the subjects and continue to move your trial forward.

Jon Speer: All right. That's great.

Isabella Schmidt: Yeah. I was going to say the same thing. The other thing that I would say is, if this is your first foray into a regulated industry like this, I would get help. I wouldn't try to do everything myself. Because regulated industries are regulated. And you want to make sure that you're compliant with the things that you're doing. Even if you're trying to run it yourself, I would at least get some advisors to help you out.

Jon Speer: Great tips. And folks, one of the best in the business is the Proxima Clinical Research team. You can again find out more about them. Go to ProximaCRO.com. And I want to thank Stephanie Mull and Isabella Schmidt for being my guest on the Global Medical Device podcast. I mentioned it briefly a moment ago, Greenlight Guru, we're here to help. We are the only medical device quality management system on the market today that's designed exclusively and only for the medical device industry. Designed by actual medical device professionals. So if you need a little bit of help with document management, setting up your quality system, capturing your design and development activities, the risk associated with all of these things are important. If you're going to be entering into any sort of clinical trial of any ways you perform in addition to just being a medical device company, these are expected behaviors and best practices. I would encourage you to go to www.greenlight.guru to learn a whole bunch more about the only medical device QMS on the market today. As always, thank you for being a loyal listener of the number one podcast in the medical device industry, the Global Medical Device podcast. Share the word with your friends and colleagues and be sure to tune in again real soon for another episode. As always, this is your host and founder at Greenlight Guru, Jon Speer. And you have been listening to the Global Medical Device podcast.


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