Episode 19: The Energetic Edye Edens
One thing can be said for Edye Edens - she’s passionate.
Edye is a licensed attorney with an international human rights, research ethics, and health law background. She spent almost a decade in-house within the academic medical center research compliance environment before transitioning to consulting in 2017. Her consulting areas with First Class Solutions, Inc., include research administration, healthcare compliance, grants, contracts, IRB, COI, education, privacy, HIPAA, multiple areas of FDA compliance related to drugs, devices, and food; AAHRPP, misconduct and site-level compliance work as it relates to QA, monitoring, and auditing (particularly oncology).
Services provided include education and training, program creation and management, or even as a complete outsourcing solution. Additionally, Ms. Edens regularly publishes articles and speaks at regional and national professional research and compliance association meetings, including HCCA, SCCE, PRIM&R, MAGI, AAHRPP, SPARC, RAPS, and AHLA, and teaches at Indiana University McKinney School of Law.
+Full Episode Transcript
Brad: All right, Edye. Thank you so much for coming on. It's a, I know we've gone back and forth. I had to cancel on you once, so I'm very, very glad you're here.
Edye: You're good. Like I told ya, you know, I think that, uh, that's one of those you got time back, the universe gave you some time back on your calendar that day and you just roll with it. We all need, we all need grace all the time, but in 2020 we could use an extra dose.
Brad: Yeah. I think we're all going through our own, uh, craziness, you know, regardless of the-
Edye: We're trying to restart right. In only various phases and capacities. And it's not a full-blown, you know, I don't know that we're ever going back to quote-unquote, you know, pre COVID times. And so that has its own implications. Plus our industry of courses on fire. Not that you would think it would be anything else as my healthcare family always never hesitate to remind me, you know, hospitals don't take holidays. There's no such thing in a hospital and they're right. But now, now clinical trials are on the evening news. Every single night, CNN has, you know, 87 reports a day on the race to a vaccine. And so, I mean, our whole lives have kind of been blown up if you're in this world in one way or another in some capacity. And so I think it just, there's an extra layer for those of us in the industry of exhaustion and knowing that the fight is nowhere near over, right? Like you don't even have time to be exhausted at this point.
Brad: Right. Yeah. And I think it's still, I mean, it's still not clear to me whether the, uh, you know, focus on clinical trials is now a good or a bad thing, or just sort of a double-edged sword.
Edye: Uh, I couldn't say enough about what you just said seriously. It, it, in the beginning I was so pumped. I used to actually make the jokes. My husband's an actuary. And when you say that to people, they're quite often like, Oh, that sounds cool. What the heck is that? And so w you know, as I'm sure you've experienced, when you try to relay to individuals in passing, who aren't going to be intimate members of your inner circle, what you do in clinical research, it's hard. It's really hard. And when you're.
Brad: It is.
Edye: an attorney in clinical research who focuses on compliance, it gets way wheatier and nerdier. Right? And so there was this part of it in the beginning, when I looked at my husband and I said, ha ha, all our friends know what I do now. And they still have no clue what you do. Um, you know, and kind of giggled about it. And really like, it was, I mean, I had family and friends reaching out to me and saying like, wow, like this is the world you're in. This is so cool. Now fast forward six months asked me if I still feel that way. You know, it doesn't bother me to have the scrutiny. Cause I think my goodness, how much scrutiny and, and, and what kind of pressure cooker we frankly already have in our industry. So that's as on news, right?
Brad: Sure.
Edye: Like, and handling incredibly time sensitive life or death matters in the field of healthcare is in fact a daily situation. So this is not something we cannot rise to the occasion for, but having it happen at a time where we are experiencing it globally, as opposed to just domestically. So you have all these varied response variables, then you also have social media and visibility the way it is in our day and age, which is completely different than the last time we dealt with anything like this. So you have several agencies in play, several laws, several different countries, several responses, you have complete visibility and scrutiny. Um, and then let's throw in just for fun in the United States that we also have, um, a very serious, you know, systemic racial conversation happening. And, and I'll leave that at that because I know that's a very controversial issue. And then of course in that same vein, you know, a topic that I will just park in the garage here, but is worth noting is of course it's an election year, a very highly contested election year for us in the United States. And so that is just to me, you talk about the perfect of all storms, because now I'm thinking, Oh my gosh, if we approve something too soon, if we don't have enough diversity focus, if we have any major, like serious adverse events, like we just saw on the AstraZeneca trial that caused pause.
Brad: Right?
Edye: Um, if, if due to any political pressures or a lack of impartiality, we make a mistake in what we approve because we're trying under such scrutiny and such media blitz pressure and with such political undertones to get this moving so fast, what will the backlash of that be? And you suddenly have, and I'd be interested in hearing how you feel about this, but you suddenly have all these individuals who pre COVID were really not a part of the clinical trial ecosystem. They didn't impact it. They didn't speak on it. It wasn't a value to them. It wasn't something that was in there. Um, you know, stump speech, it wasn't right. And, and now it's on everyone's purview and it's a bit scary to me to have individuals who might otherwise be relatively unfamiliar with our industry, the way it works, the historical underpinnings of some of our regulatory infrastructure, um, the actual day-to-day boots on the ground, right. Operations of research, and what's realistic and what's not, what's safe. And what's not that scares me that those individuals might have a particular influence or say on how quickly we approve something or how quickly we move something forward. And that there a could be something besides science behind it in any way, shape or form.
Brad: Right.
Edye: -and, and B the downstream effects may or may not actually be played by, you know, played out on that person or that community. It will be you and I, who were in this industry pre COVID. And we're likely to be after COVID, who will ultimately pay that price and even more than you and I, the patients, right. Because, and just terrifies me, cause it's like, it's this opportunity to, to advance those 30 years or set us back 30 years all in the same moment. So no pressure, no pressure.
Brad: Yeah. Right, right. Yeah, no, that's, that's exactly right. I mean, it's, uh, you know, we pray that we're not, you know, repeating, uh, some of the terrible history, you know, that we all are aware of in clinical trials and, you know, all personal opinions aside. I mean, it's on one hand, fascinating to see it actually play out on such a big scale and see how it interweaves through all these things, whether it be, you know, uh, political and social issues, you know, that are going on now. So in one way is it's sort of, I don't know, the gratifying, I guess, to see the true impact it has, but, you know, on the other hand, it's also, like you said, it's, it's frightening to know that, uh, people who maybe have really no concept buy-in or idea about what they're talking about, having a large effect on the outcome.
Edye: Right. And it's also, I think really a strange time for those of us who have been in the industry and come from such data and scientific driven backgrounds, whether that's in our education training, whether it's how we implement our operations and our policies, whether it's our role in the industry. And right now, a lot of the decisions that we're making, aren't based entirely on science, and that's not a cut at political, you know, issues. What I mean, when I say that is you have to factor in more than just science.
Brad: Right? Right.
Edye: Okay. And, and, and this implicit belief by professional clinical research professionals, that science is real and that it's not up for debate is step one, right? Us recognizing that outside of our individual industry, there is a growing ethos that does not blindly accept that and, and wants to seek out multiple sources on ones to vet and verify and makes their own decisions potentially about what in fact is real to them as scientists, what they're going to stand behind. And that's, that's, I think contrary to how many of us in research are just wired, right? Like just who we are like, uh, I don't know if you're a big bang theory, uh, uh, watcher, but my, my partner always says to me that I have Sheldon broken face sometimes, like it explains something to me and I'm like, Oh, like, no, but that doesn't know. So, you know, I don't understand that line of thinking, but that doesn't mean it doesn't exist. And that doesn't mean it's not valid. And then you layer on top of it. I mean, I don't care how smart you are and how incredibly well versed you are in vaccine research and neurology. I mean, this is new, this is different. None of us have a playbook for this. You know, whether you're in the C-suite or you're in the lab, nobody had a playbook for COVID. Okay. We still don't. We're still, we're still all working a bit on the fly here. And then you also have the litigious world we live in, you know, and it's not lost on me as a licensed attorney is that many of these decisions are very much based on, okay. Maybe the science says I could potentially open my doors to in-person classes for my kindergartners right here. Throw that out there. Cause you know, Yeah. Young kids in daycare, on my mind as a parent. Um, but the reality Is if everyone else in your area, isn't doing that. If that's not what your quote unquote industry practices right now, even if the science suggests it's okay, under certain conditions, you probably didn't move forward with that because you could get sued and you who are worse, wants to be the facility, the organization, the hospital, the school, et cetera, that opened their doors too soon. You know, hindsight's always haha-2020, but, but realistically seriously, who wants to be the person to open their doors, you know? And then a disaster happens that has complete, awful written all over it. Nobody wants to be that. And so now there's just all these other pieces and variables in the pot, you know, no longer just, you know, cooking the chicken, it's like the chicken and the vegetables and the fruit and the dessert all got thrown in. And you're trying to go, wait, wait, wait I just wanted to have chicken, that's all I was looking for. And, and For those of us who are really good at making our chicken, You know, admittedly, we've gotten to operate with just, just chicken, maybe some vegetables, this is new. This is really eye-opening. And so it's, it's really interesting. I think it's like you said, it's really interesting. I'm super curious to see data captures and metrics and statistics as we progress and actually have had enough time to have enough data to really start to learn what's working. What's not my hope is that we'll start to maybe go away from panic.
Brad: Right.
Edye: and a little bit closer to science again. But like I said, there's still political and industry pressures to do things a certain way. And certain folks are going to go back sooner than others. And certain things are going to be acceptable for one that's not for another. I also think there's a personal dynamic. Like when was the last time, you know, you had to respect any one, whether personal or professional, any vendor, any service provider, even just a friend or a coworker when they said I'm not comfortable coming back. Sure. I would like to remain remote I'm at higher risk. Someone in my home has been exposed. We've never had to deal with that on literally a situation to situational basis in our lives. Um, in a way where we just have to respect. If you have someone who says I'm not comfortable, you actually have to deal with that. You know, we're not in an, I mean, I guess you've done, You're going to come to the officer. I'm gonna fire you, but I would suggest not working for that organization. Okay. Easy for me to say, but, but realistically though, seriously, that's a huge change in the ethos of your companies and your cultures, how research is being conducted, which places can actually keep it moving during COVID. And which just had to say, I'm sorry, we have to suspend trials for awhile. Um, and how that played out. That's actually super interesting to me, right? So I'm thinking about this from the angle of your huge power players in clinical research, the quote unquote traditional research model, right? That is a major hospital systems, academic medical centers, you know, universities, Titan, et cetera. Those are a lot of the ones that really had to shut down, honestly, would have to have people on campus, you know, to, to large operation, to just go, we'll only this department can come in, you know, it's way too big and they're not, you know, and they'll tell you this, I'm not dinging on them. Uh, they're not, uh, well known for moving quickly, right? Not highly, highly flexible lean tech forward organizations in terms of operations and management. And so, and, and they got too many people to take chances. And so, you know, they just, they just said remote boom, March 15th, boom. And they sent their students home. They sent their staff home. And so that's a far cry from your leaner based sites that are based out of a community physician practice. Maybe it's a commercial site, maybe it's a startup or a biotech or a site network who frankly already did remote assessments and were already working, you know, as much as they were allowed to, um, in some of these virtual modalities right. To, to, well, they had to obviously get over the speed bump in the spring of being shut down. Once they got their wits about them, they kept going. And so for the first time, I think in I'd venture to say forever, although I don't like it, Absolutely the attorney .The first time, and we'll say a real darn long time, the big players in our industry, in the throws of COVID actually had to say, sorry, pause button and the little guys, right? We're the ones who said, or the medium guys are the ones who are going to make this happen, give us a week,
Brad: Right
Edye: Let us let us work with some home health services, let us get some vendors in place. Let us get, you know, IP set up to ship to patients' homes, let us set, you know, and, and just pivoted in this way that the larger organizations knew they might not be able to, and just didn't attempt to in certain spaces. And, and again, I get why I get why, if I was at one of those larger organizations, I would have said the same darn thing, but it just was a complete role reversal. And it's created a whole different power dynamic to me in the industry. I think you would have seen in the next five to seven years, some of those individuals become players and bigger players because they do offer so much flexibility because they are recruiting at higher percentage rates because they go so above and beyond, right. Not lose a participant and they really will come to your home if you need it. That is what it takes to keep you on trial. And when you just can't do that at those huge centers, but it was just it expedited it instead of it happening like in 2025 or 2027, it's here now. And I'm actually seeing from my client book and I'll work with, you know, any and all and have the unique privilege to, but it has been my smaller to medium science clients in those spaces who my phone was ringing off the hook in the spring and the summer, cause they're going, we gotta move and we gotta move fast. Tell us what you think. And I mean, some of the most exciting, but also some of the scariest conversations, right? Cause I'm like, I don't know, are still rules, unlike everything else in my life where there's, you know, a rule or Regulation, a manual, a best practice and FDA guidance documents and case law something. I mean, this really was like, unchartered waters, but I also saw the passion and the fact that they're like, you know, I'm not letting my patient come off. Something that could be meaningful to their therapy. I don't want to lose the data integrity. I, you know, and frankly, I don't want to lose the business. Right. Let's be honest, it's a business too. And so it was just, it was just this moment that was so empowering to that part of our industry. And that is, you know, all the good, all the bad. I really want to see that stick, man. I want to see it stick in a way that very much greases the wheels for your larger systems to begin heading that way. No one expects your larger systems to be nearly as lean and flexible as these other types of sites. They're just a different type. But I do think we could be doing things more efficiently, right? Like we could be doing things a little bit smarter instead of harder. Um, and so that's my hope is that that will kind of have a really positive effect across the industry of seeing just what you can do if you really put your mind to it and your resources to it. And frankly how cost efficiently, some of them are doing it because you know, a lot of your smaller sites, we're on a pretty tight budget. Um, there's not a lot of room for error there and I hope it would, the message that we'll send to sponsors is that, you know, we should be going to every different type of site for research. And I understand the minutia implications, of course, certain therapeutic areas are stronger in certain types of research entities. Fair enough. Sure. You don't find a lot of phase one, uh, programs outside of some of your larger entities and there's good reasons like got it, but just globally, very, very 500,000 foot level.I would really like to see the takeaway be here that there's just as much value in us having a site in a community-based physician practice or a lean site network, as there is doing our research at the heavy hitters out there, you know, the Mayo, the John Hopkins, right? The Dana farmers, um, that they, they hold equal value and should be equally considered. I also think that's a road to cleaning up our diversity issues in clinical research. Um, absolutely because man, those, those leaner smaller medium-sized guys, they are the ones who are going to reach populations that, that huge hub model just struggles to reach whether it's for socioeconomic implications because people can't take a week off work and go to the big city. Um, you know, every time something's going on, whether it's, um, just at a community level, having certain focus or certain community ties and conversations, um, that really empower certain populations that otherwise get a little bit wallpapered in, right. Um, to come out and to speak up and to say, well, if you restructured it this way, or if you did it this way, we would become a part of this. Or we would be a part of this and to show what can come from that. Cause it's going to take a lot of positive reinforcement and seeing what it can do before it will become commonplace. And we certainly with what's going on in the United States, um, in terms of our social issues and our conversation on race are, are aware. I think we're awake. I just pray every night that we're listening. Um, but I think that does create a unique opportunity for us in clinical research to say, my gosh, if, if COVID is going to upend how we go about doing research or all the different ways that we make available to people to participate in research, why wouldn't we go all the way and, and make some change then to diversity while we're at it? You know, if you already, you're already taking a top down approach and making some drastic changes to an industry, wouldn't you just go ahead and go all the way. Like let's not, let's not halfway go. Um, you know, you don't want to yank the parachute out like a hundred feet, you know, take it off 100 feet before you hit the ground. That's kind of not worth it. Um, so I don't know, maybe I'm out there, but I definitely, those have been my takeaways from the year, very big picture of, you know, where we're at and frankly, where we got to get in this industry. Um, and you know, of course all of that takes a back seat to people are dying from COVID. This is serious. This is really freaking serious. There's no doubt about that. Um, and you know, it's, it's a darn scary time. It's hard to get away from everyone's operating on COVID fatigue and yet we're more needed and more desire than we've ever been. I mean, we are, we are on, on demand and we are, like I said earlier, you know, highly visible. So I think we've got a good, another 12 months at this intensity level. I know everyone always say that he was probably just cringing in their chair, but, um, but I just don't see how we get to next summer. Not still being pretty much on full tilt, even if, even if we're able to accomplish some vaccine drops, which I hope are very meaningful and helpful and come along much faster than many of us in the industry anticipated actually coming along in a truly, um, you know, effective manner that's safe and meaningful for all involved. Uh, I still don't see how on earth we're coming off full tilt until next summer. And I think that's probably honestly optimistic because I can't swallow saying like 20, 23, I just need to have it. I just think we have some time ago. I mean, if we're being really honest, we do, right. Like,
Brad: No, I think you're, I agree a hundred percent. Yeah, no, I don't think I would not even venture to make a guess as to when this will start to stabilize a little bit at this point. I mean, I sure don't think it's going to be before the end of this year, but beyond that, I I'm not even not even going to wager a guess.
Edye: Yeah. I think, you know, I also think there's some notion that we're all gonna just like forget this ever happened and go back to a pre COVID world. And I think that's not a little, it's a lot unrealistic. I mean, there are some ways, and I'm always about finding the silver lining and crappy things and crappy moments of, you know, we have learned some jobs could go remote and some people enjoy working remotely or new ways to work through different problems. Or, you know, like I was saying, some of my more lean, um, pivoting clients have really figured out just how much they can do in the home and how virtual they can go. And that's opening up whole new therapeutic trial areas for them. So there's a whole lot of good in being in this pressure cooker for, you know, at least the rest of the calendar year, if not possibly a few more. Um, but man, it's hard. It's really, really, really hard. Um, and you know, the toll that that's taking on people and obviously the, the mental health and wellness that comes with all of us having restricted social activities. That's pretty darn tough too.
Brad: Yeah, for sure. Well, I mean, you know, at the end of the day, we're, we're all in this together.
Edye: I sure hope people. Yeah. That's how I like to think of it a hundred percent, a hundred percent. Um, but yeah, no, I could talk about this for days. I mean, just because there's so many different angles and viewpoints and, and that's before you even get into the actual science science,
Brad: Right right.
Edye: The research of COVID. Um, and then of course, you know, there's a whole world of science and research on issues of, of race and inequality. That also are a huge conversation piece right now. Um, and that cross across our divide. And so, you know, man, what a, what a year,
Brad: What a time to be doing what we're doing. I mean, couldn't, you couldn't ask for a more interesting time.
Edye: That's what I keep telling I, in addition to consulting, um, my, my other career as I teach, and I'm certainly not a tenured faculty member, nor am I aiming to be, and I have great respect for them, but I have been very fortunate to teach when I move into clinical research and had left law school, I knew I hadn't taken full advantage of the health fall offering because like I said, that wasn't my intent in transferring to that law school. And so I just thought, Oh, I didn't study this. And since I very serendipitously after had graduated and was practicing fell into clinical research thought if I went back and got another degree or I'd gone through doing the health art program, I mean, there would have been classes, all of us. So I, in my true little academic spirit, you know, treasure over to my law school and talk to some of the health law folks and say, you know, can I see some course list and maybe I'll do all this and that and the other and add another set of initials to my name. And they're like, yeah, no, there's not really like courses in clinical trial compliance. Like what are you talking about? You're silly. And I turned and looked at them and said, I can see the medical school from your office window and you're, and Oh, by the way, that red, that red dot that you see out of your other office window that's Lilly. And then we all know Roche is on the North side of Indianapolis, that's their North American headquarters. So you're a top 10 health law program. And you're telling me there's no value in having classes on how to conduct clinical trials and research ethics and life sciences compliance in this city. That seems kind of silly. I mean, that's the largest medical school in the United States. Like, you know that right? And it's, it's, it's right there. Like you park in their garage every day and walk over. And I was just flabbergasted. Like I was like, whzch-what? Your, like when you mean, we're all flying by the seat of our pants kinda? And learning this past week. And so that was really, I got into teaching because of that. And it was very much meant originally to be like, you know, one class every now and then, and it has turned into now, I actually am the director over the Hall center, which is our health law center within the IU, the McKinneyschool of law. So I am the director over their experiential learning. So any type of health, law, internship, or externship that our students would do for academic credit, I actually recruit our healthcare partners and clinical research partners that offer that to the students so that there are a ton of offerings. And then I personally pair them and do curriculum with them throughout the, at least their first experiential learning experience with me to really maximize their opportunities in health law and get them to understand the ethos of health lot large, right? Like what they're going to see in the industry. And it's always, it's always a, you know, an eye-opener like, for example, I'm probably one of the only externship directors because there's tons of experiential learning opportunities throughout law school in different areas of the law. Again, to you, I'm the only program where you have to go prove you have all your vaccinations and you've taken a flu shot and get all your, you know, immunization records and get a TB test and so on because you're going to be in a hospital or a potential clinical research facility. And that is actually so commonplace to all of us who are in it.
Brad: Right.
Edye: But to a law student, they're like, you, want what information about me? Like, that's none of your business. And so it's just really honestly like getting them on board. And one of the huge things I've told them, because of course I have students who are graduating this last spring in the middle of COVID, that's tough. How do you, how do you possibly make right with them that they don't get to have a huge graduation ceremony, let alone, they're going to study for the bar exam while they're learning it remotely, which is just not how that has ever been taught or learned. And there was so much uncertainty. I think, you know, you have students who are going into another year of law school of uncertainty like this. So, you know, many of them were like, Oh my gosh, you know, what am I going to do? I'm not going to get externships. I'm like, okay, first of all, healthcare, didn't shut down. We got bigger during this. So I have more opportunities than ever, even if they are remote, we will make them worth your while. And instead of focusing on what you think you're missing in each opportunity, right. Instead of saying, well, I had to work her mode on this externship. So I didn't really get a full experience, but here's what I did. I mean, that's not a very confident sounding pitch to a future employer about your skillset. Instead of what you're going to say is I did three externships in the middle of a pandemic. I was able to assist this healthcare entity in supporting the following projects from the comfort of my own home. Imagine what I could do if you let me onsite and that you can see like the light bulb goes on and they're like, Oh, what I'm like, yeah, we're capitalizing on this. We are not going to be victims. Okay. We're going to say I still persisted. I still made law school work for me during a global pandemic. What do you think it can do when we're not all freaking out about COVID and I think that's so part of what our clinical research ethos has to be too. Righ? And what healthcare has to be saying in this moment, um, because otherwise with all the other variables we were talking about earlier, it'd be pretty easy to get cynical lost, jaded. Right. But that's one of those big deals. I mean, I think this is, you know, we'll be able to look back 10, 15, 20 years from now and say like I was doing clinical trial work in the time of COVID research. I was, you know, helping clients move into de-centralized trials for the first time in the middle of the global pandemic. Imean, you know, I was writing, I remember writing emergent home, visit SPs and workflows for clients last spring and thinking I could never have dreamed, I would have been writing this. I thought I'd be so excited to be writing it. And now I'm just freaking out because I'm not sure what it should say because it's not something that's been done enough that I could research it. Right. And go like, this is where they went, right. This is where they went wrong and you know what, uh, I got to do it and I got to do it today. And so it was just this like mindblowing time. But I think it can be, like you said, we're all in this together. It can be super collaborative. I mean, it's made us have to talk to one another, a little more. Right?
Brad: Sure.
Edye: And learn what we're all doing and, and take in each other's ideas more, um, and collaborate a bit more so. And I hope that's a continued, you know, because we have to work more for that collaboration because we are all at home and whatnot, maybe then that will be more meaningful and it will last a bit longer. This is my hope. If that makes any, any cheesing sense there. I just want everyone to get along.
Brad: Yeah. No, that makes that no, that, yeah, that makes, that makes it makes perfect sense to me. Yeah. It's just, just, it's so much uncharted territory. I mean, it does, it's gotta be, it's gotta be collaborative. I mean, and you know, it's, it's encouraging, uh, you know, even just conversations like this, I think are encouraging where, you know, you know, if we can, uh, speak to the greater community and sort of, you know, get more and more, more buy-in from everybody else.
Edye: And, and to hear what other people are doing. I mean, I've always been a sponge and someone who truly appreciates hearing lots of different ideas. I can't promise I'm going to agree with all of them. I can't promise I'm going to use all of them or that they work for me or my clientele or my needs. However you want to put that, but I definitely want to hear about it. And now more than ever is a time of great conscious, active listening. Um, and, and, and if we can truly do that, we could turn this into something amazing, but I also, you know, it's that double-edged sword, right. It could also be a dumpster fire. Um, and that's a really narrow line between those two and that's, yeah, that's, that's scary. That's really, really scary.
Brad: It is, it really is.
Edye: Um, and I think there's an ethos to it too. Like how do we support the folks who are boots on the ground doing all of this? I mean, it's easy for me to pause it, all these pretty ideas from my corner office at home, I'm not the one who's at, you know, an ICU at a trauma, one level center, dealing with COVID patients and being exposed all day. I might have some very, very different views on some of these issues and how it should proceed. And so, you know, that's where I'm like, man, we all have to be listening. Um, and we all have to be absorbing what we're hearing and being willing to talk to folks who might not necessarily, you know, be a hundred percent aligned with everything we view and feel. But that's about the only way I see us getting through this in one piece in the upright position. Right.
Brad: Yeah. I could not agree more.
Edye: So now that I'm done with my big soap box
Brad: Yeah. Let's go backwards after we've already, we've solved all the problems, right?
Edye: Problems clearly. Right? I'm totally kidding not like that I promise.
Brad: That's okay. I think, I think, uh, I think our listeners will understand, so, but going backwards. So how did you even end up in clinical research? What led you down, down the path?
Edye: Right. So, so I end up going to this killer, great law school that everyone upon everyone is there to do health law and people are looking at me like, so let me get less straight you're. Both of your biological parents are attorneys they met because one was getting a master's in public health while the other was going to medical school and had those full, robust careers before then both going back to law in their late forties, early fifties, when I was in high school and pursuing further healthcare, um, jobs like chief medical officer quality compliance, and you're going to go to law school and you're not going to do healthcare or anything related to it at a top health law school. I'm sorry. What did you like where you dropped on your head? And so this is, I mean, I heard this over and over and over and over in law school and I'm like, no, no, no. I'm really what I was focused on was international human rights law. I had a very unique opportunity to begin setting abroad very early. Um, you know, my, my parents, despite us being in rural Oklahoma were very open to learning. You know, I was like learning Spanish at two. I mean, they were just all about different cultures and my father's parents traveled the world. They made a huge effort to go see all the, all the greats, right. You know, the Paris, the London, but also the places that you never hear about. Right. Um, and, and they just, it was such a part of their lives to give back to their community, to be involved, to take care of individuals who didn't, you know, have a voice all in their own quite yet, and give them that voice. And that just transcended to me all that healthcare work and frankly, anything I was going to do right here, I am in the middle of a very poor town. I am the privileged kid of a physician who's doing well and can afford to throw me in a private school, man. I'm the picture of who I privilege. I got to get back. That is what universe needs for me. That is what they're asking for me. And it is frankly, what I have to do. I will not have lived my life's mission without it. And so, because I was studying abroad at such a young age and in high school, you know, going places as far as long as even Russia, um, I just began to see all these different cultures. Right. And it became very clear to me how good I had it, not just personally, but frankly, as a country. Right. You know, and as an individual and I was really interested, I had gone to, um, college, slightly entertaining. The idea of medical school took a lot of science classes realized pretty quickly that that was something I could do, but it might not be where my ultimate passion and best and highest talent was. And I'd always had all these, uh, writing and speaking skills, which was pretty rare for someone who was otherwise in the sciences, right. You're supposed to be like nerdy and super awkward and, um, unable to socialize and so on. And so, you know, I got really pointed out for having these skills and being able to like write a five paragraph essay on my sleep. And I was real sick in college one semester. And my dad said to me, you know, if you still think you want to do this med school thing, you can't let your GPA tank. So this is not the semester we're going to take, you know, O-CHEM, right. This is a semester we're going to get all your other requirements. Go take a bunch of English classes, go take a bunch of foreign language classes. Edye, that'll be easy. We can get your health back on track. And you know, it won't tank your GPA and then you can go back to business as usual. Well, the problem was, I didn't want to go back. Um, that semester was some of the best grades I've ever made while I was actually having the most fun I'd ever had in my classes. So I was very like, Oh boy, okay. So I got to go home and tell my, you know, 18 initial father that I'm going to be a creative writing major in college, and that's going to be an awesome conversation. And, and because of that, I lean toward journalism and PR because those are ways you could use some of those skill sets and make money. And because of that, I started to actually, as I was traveling, pay more attention to journalism and the folks who were reporting some of these human rights atrocities, and they were then targeted because often your major news networks internationally wouldn't go into war torn areas. They would contract with the little guy who was willing to go in and would get able to follow, um, you know, a certain group, right. That was protesting and get that frontline coverage. It also put that contractor, that individual at risk. And I did this incredible, uh, internship in college overseas that led to then me realizing this is it. This is my passion. I got to devote everything. I've got to human rights and making the world a better place and taking care of the individuals out there who are trying to do right by the world and giving them a voice. And so that was my whole mission. That was what I was going to law school. I'd worked for, I'd gone back. It was my whole purpose. And, uh, this particular school IU McKinney had a very strong, still does program, international human rights law. So I mean, and it worked, it was great. I got to present at the United nations twice before I left law school. I mean, Holy moly, I got to do internships in Zambia. Um, and, and so this was an incredible opportunity. I also graduated in the middle of a massive economic recession in 2008. And even my friends who were in the top 1% of our class had their job offers handed back to them because nobody, if nobody was hiring. And so now you've done everything you're supposed to do. You've traveled the world, you've gotten all the accolades on your resume. You're thinking you're pretty hot stuff. You pass the BAR exam. And you're like, so I'm going to work retail, maybe bartend on the side. That sounds pretty cool. Good, glad I made the honor society. And so, so suffice to say it was just a super tough time. And a colleague came to me and said, who had been all about health law? And frankly had gotten involved in IRB compliance that IU and was in the HRPP as, um, at the time an assistant director for, uh, the IRB system, which I use quite large because they support not just I, you and all of their partners. Um, but most of the city, frankly. And so, so she comes to me and says, I've got a project for you. It's going to be a contract job. I had just accepted an air force JAG core offer because I'm like, well, they're offering jobs. It's a pretty, you know, highly regarded job. It would get me international. I'd see some things, I do some things. And when my four years is up, you know, maybe the market will be different and I can try this again. I got to get a job. And she's like, yeah, yeah, yeah. I know you leave in nine months for that. And that's super cool, but I have an IRB consultant contract, and I know that's not entirely your cup of tea. I also know you can do it. Compliance is your cup of tea. You have the skill set you've been, you know, you've gone to the United nations and called out foreign countries for not complying with the ICC PR. I think you've got the cojones to do this. Um, and, and I can bring you up to speed. We'll give you a deep dive into the regulatory matter. I just need to know, would you be interested? It's a nine month contract. So it's perfect timing for when you leave for the JAG CORE, you know, everyone knows you're leaving, so it's not like you'll ruin your rep by walking out or anything. Um, would you be intersted? So I was actually an IRB consultant before I knew what an IRB stood for or what it entirely did. And I entered the university in a very different way because I was a contract employee. You know, there was no formalities of moving up the food chain or trying to like get ahead or playing politics. It was the so nine month contract I'm gonna do right by my friend. This is way better than bartending an retail. And then I'm going to take off in nine months. And so it became almost like a game in that nine months. Um, you know, I don't want to air out anybody's dirty laundry, although it's public, I, you just had a, uh, a tense time, we'll say, um, with the federal government, there were some whistle blowing activity and some things that just simply needed to be remedied and overhauled, and they were successfully, but it was a very intense time, you know, they needed outside consultants to do that. We've all been through a time like that. And so it almost became like a, an inside joke that my bosses would be like that this really particularly difficult situation, you know, kid gloves sensitive, um, who, who wants to draw the short straw and try to deal with this. And I'd be like, Oh, well, like I'm, you know, that's okay. Like, even if it's awful, I'm gone in a few months anyway. And I would, I'd resolve it pretty quickly and come back and be like, okay, well, like I fixed that for you, Brad, what can I do next? And they're like, no way, no way. And then, and then it was like, let's give her something harder. Let's see if she can handle this. You know, this will take you, this will take you the whole month and I'd come back a week later and be like, well, I went ahead and got that done for you. Did you have something else you want me to do? And so it just became almost being treated like a consultant within this particular situation. And at the end of the nine months, I got offered a job and I stayed, I ended up staying at IU for almost 10 years and long gone was the, uh, the air force JAG CORE. And certainly not long gone that, that human rights background or that international, um, love of taking care of people, but then was born Edye the clinical research . Right. Um, and, and I had the unique opportunity because I continued to work with many of the same people that I'd worked with in that contract capacity. They, they utilize me almost like a consultant throughout the HRPP. So I started in IRB, started moving more into quality assurance and clinical research compliance, and the auditing pieces that come with that, that very organically moved us into research, integrity and misconduct issues. Um, as well as, uh, statewide IRB projects and conflicts of interest that came with that. And all of the training, of course, that comes with all these different areas. And then I moved into the ICU Simon comprehensive cancer center, and it was, it was me needing and knowing I needed to have some site level experience, but also knowing that the Lillian Roche, you know, in my backyard, and even the coven says and other great heroes of the world that are located here, they weren't going to take someone who was viewed as somewhat the enemy, if we will. Right. Like I, I was viewed as an IRB person. So the misconduct police, um, they're not going to take you with open arms for starters, as well as I didn't have the site experience. That was a, that was an accurate statement. I hadn't done that. I thought I did. Right? You know, I'd worked with sites endlessly, but I hadn't really been on that side of the fence. And I knew I needed it. I was interested in it. So they were, the, the cancer center was in the midst of creating a quality and compliance manager position because they had all the moving parts, but they didn't have them all connected, right? Like under one umbrella that was truly an A to Z quality and compliance officer for all the research that was happening. And, and frankly, they'd gotten really big, really fast. I mean, that cancer center was only open unveiled 12 years ago and that's counting from today and I left them in 2017. So you're talking about, you know, just a handful of years before that their in-house clinical trials office was a handful of people. And now it's over a hundred. I mean, it was fast growth. So went over there and did that for a few years. Um, loved it. I mean, fell in love all over again with the industry, honestly. Um, and, and found myself loving site work just as much, if not, almost more than the HRPP work and, and just realized, you know, okay. Eventually my run at IU is going to hit a ceiling. I need to get ready for that next step. And what I've loved about my career is that I've had this incredible opportunity, um, to be utilized so many different ways on so many different projects. And it's expanded my breadth and my bandwidth. And it's also being in an age where I know myself well enough, you know, to know what works and know what doesn't for me personally, I gotta be engaged. I gotta be constantly challenged. I, if, if you give me same old, same old I'm done, I'm gone. I'm not saying that's positive. I'm not saying that's not something I should do more on, but I know myself well enough to be honest about it. And so I'm like, okay, consulting is it? And it was interesting as I went out, looking for firms, I really thought the, the, what I would call silver stocking firms, right? Like the heavy hitters out there that everyone knows the names of in healthcare and, uh, clinical trial, complainants and research consulting would be like, Ooh, ah, cause of course we always think highly of ourselves. Right. And they did, I was like a unicorn. They didn't know what to do with. Cause they're like, "So you're an attorney, but you're not at a firm?" Nope. "But you're an attorney?" Uh huh. "But you weren't in general counsel's office?" Nope "But you're turning with an ethics background and you you're in clinical research operations? but you're not like a nurse or a doctor" Nope, Nope, Nope, Nope. And you could tell it was again, the Sheldon broken face, right? Like what do we do with you? And you know that, plus I admittedly wasn't bringing a client book. It was going to take a little bit of time to build one. They pretty much looked at me and said, we either don't know what to do with you. We don't have a role open for you. Um, come back when you have a client book, I actually had one, tell me you should go to a firm and do the partner track and come back in about 10 years. And I was like, Nope, heh,No. Um, and, and it was, I was, it was kind of, I mean, it was like, it was a kick to the teeth cause it was like, Oh, you're not this hot commodity you thought you were. And so it was very, again, serendipitous. I was, most of my career has been and I'm so very grateful for it. Um, that, that I knew of first-class solutions, the current firm that I'm with through other compliance professionals, both in my space and in what I would call the clinical compliance. Non-research like chief medical officers and folks who were in the quality department and do case management and, you know, medical record departments, et cetera. And first-class just continued to came up. Right. And they were, they'd been around since 1988. They weren't new. They obviously have, you know, a really sturdy base underneath them. It was a couple who founded them and they really started out heavily in healthcare billing and revenue cycle management. And still very much are in that space. But of course that space grew and changed as we came into ICD nine and 10 and coding and compliance and all the implications that has, of course in the nineties and early two thousands, you have privacy and security blowing up. So that becomes a huge issue in healthcare. Um, and they're in the midst of building, you know, health information management software. And I'm like, wow, this is an incredible firm. And their client book is filled with people who do research. And I'm like, I wonder if one of their co-founders would talk to me, right. Just 30 minutes, 45 minutes on the phone mentor, a poor lost soul, um, has pity on me, come on, I'm trying over here. Right. And so I asked for an intro and I received one, it was to their chief operating officer and co-founder Rose Don, who is now my boss and got on the phone with her. And she's a very straightforward, she will tell you the truth, which I so appreciate about her. And so we talked through what they were about and we talked through what I've done, where I've been, you know, she asked some pretty pointed, pointed questions cause she doesn't mince words. And I just asked her, I mean, very point blank. My crazy, have I lost my darn mind thinking that I can do this right. That I can pull this off. Um, is there not a demand for the supply that I feel like I bring to the market? And I tell you what, uh, at the end of that call Brad, I had a job and she said, Nope, you are spot on point. You're exactly the energy I'm looking for. If I was ever going to get into research, we have the client book, they just need to know we offer these services now. So let's sit down and talk about what the heck your services are going to be because I'm not a subject matter expert, but you are. And you're going to do not only consulting what you're also going to, you know, oversee and build the line, right. And help me make decisions about how to make this offering. And of course, we set it up in a way that was super high risk, high reward for both of us, you know, a lot of safety net there and it just took off. Um, I couldn't dream in, you know, three years, which is almost to the date, right? Because September, 2017 is when I officially onward the first class I could not have dreamed in three years, I could have done as much as we've done. You know, we're dropping educational models with clean biz. We have partners like Alexia clinical services. We're working with, you know, any, and every client you can imagine across, uh, the clinical trial life cycle out there, um, in these unique areas. And I'm even now in a position where I'm bringing in more subcontractors than I can count, right. Because like I was saying to you earlier, I'm getting, I'm going to having to almost delay clients, which is just, I mean, I just, couldn't be more grateful. I'm getting to do everything I love doing. I'm getting to use what I feel are my strengths. My firm's bringing up the weaknesses. Right. Um, and do something that's so meaningful in a time that really needs it more than ever. I mean, to know that we were building this, you know, three years before we could have ever anticipated being in a COVID world, fully moly. Um, I'm so glad that the timing struck the way it did, if we, if we had to have a global pandemic. Right. Um, and so it's, that's it, and it's a, you know, a bit long-winded, I don't hesitate to use words, but it was just this unique entry and has continued to be this really unique journey. And I think it, it helps that I can talk to my clients from a personal pivot point and tell them, like you kidding? do you know how many times I've pivoted in my own short career? And how many more times I expect to frankly. Um, and so, you know, approaching with a bit of a different environment or a different approach or different background of experience and not being someone who said, Oh, I'm going to law school. Oh, I'm going to be a clinical trial professional. No, this was all not in the master plan, not even remotely. Um, and yet you can tell I'm excited and passionate about what I do. And I do think it's a way to give back, uh, to the universe at large. And I do still think it honors those principles, right. That I, that I love so very much about international human rights law I wanted to work on. Um, and put you in a position to actually remedy the shortcomings you see in industry because you're coming at it from that perspective. That was always what I wanted to do. I just couldn't have ever dreamed I would do it here or quite like this. Um, so I think that's it, you know, I think that's, and, and I think everyone, I, it's funny how many people I run into who tell me they have a uniquely, uh, serendipitous or accidental compliance, professional story. Um, I think there's even a book that Roy Snell put out where he, where he used the title of the accidental compliance professional. Um, I think it's actually very endemic in our ecosystem because often your organization says to you, Hey, we're going to move in this direction. We're going to need you to catch up Brad. And, and now this job is going to include this and this too. Right. And so you get put into these moments. I mean, maybe you were already in clinical research operations, but suddenly instead of just being over the regulatory team, you're also over the auditing team, like surprise, you're now a QA professional. Um, and so, because that just happens in healthcare, it's part of how we, um, even make our assignments and assign management and leadership, which is another topic for another day. I disagree with, uh, fundamentally, but it is how it takes place. And because of it, I think there's actually more of us that were probably, uh, somewhat accidental or serendipitous as I like to say that. Right. I don't know that many people who were like, Oh my gosh, I know when I grew up, I'm going to be like, if my kid says that to me, instead of, I want to be a fireman, mommy, or I want to be a policeman, I would be like, you know what mommy does? Like, wow. So, so that was it. That was how I got in. And, uh, it's been a blast. It's been an absolute blast. Um, so yeah.
Brad: Very good. Yeah, no, that's, I mean, yeah, I hear it from almost everyone. I talked to just the sort of, sort of accidental fall into the clinical research world, but then people, I mean, they do find they have a passion for it and ultimately that's what it's about. Yeah. Yeah.
Edye: Well, it's about the skillset. I mean, if you've done compliance in any area, you have a certain skillset and enjoyed it right. And want to continue to it, then you can pivot. Right. And there's a lot of different lesser recognized areas or depths in compliance that frankly transfer. Um, and, and, you know, people, I was like, yeah, but you're not clinically trained. I would say that works to my advantage. Um, because I'm not going to get caught up in the clinical details and trying to make a clinical argument. I am going to think the way your regulators, and I'm going to tell you how they're going to look at the situation and I'm going to be able to give you the worst case scenario of what an auditor is going to say to you, so that then we can backtrack and go, how do we never let that happen? How do we put everything in place? Um, and I think that, you know, for clinical professionals to do what they do, even just in clinical care, let alone in research. And in some of the really tough areas of research like oncology, there does have to be a certain resilience and optimism in their personalities. Um, we know there's some aggressive overtones, right? And, and I mean that in a positive, right? You want your physician to be aggressive about your care, if you have cancer, um, or as I call it stage four scary, but that doesn't always really well with an auditor or a regulatory infrastructure because it comes off as Oh, so you're above it. Oh, you think the rules don't apply to you as opposed to no, I'm just trying to be aggressive and give my patient every option to live. Right. And so I think that that's where my background is actually that, that unicorn uniqueness of I can see the argument they're making, but I'm thinking bigger picture. I'm thinking of the other 699 clinical trials. Your organization has open. And how, if you must this one up, they could all get shut down at once. And then not just you telling one patient they're ineligible. Unfortunately, now every physician is walking into every patient room telling all of them that their treatment has to be suspended temporarily. If not permanently. I know you don't want that. So let's start from the top. And I don't mean that to paint a doctor in a bad light at all. I mean, good heavens I have how many in my family, um, I have the greatest respect. It's more of, Hey, I'm here for you. Okay. Let's make this work like, and, and, and let's approach it instead of, well, what will they allow me to do? Or how far do I have to push the boundaries to get my way let's approach it from, okay. Tell me what your actual objective is. Take all the blinders off and all the regulatory constrictions out of the way. Just tell me in plain speak. What do you wanna do you wanna enroll this patient? Okay. Why? Because I think that they could derive therapeutic benefit and, or I think that they would be a perfect, you know, person for this. Okay. Why don't they fit the eligibility criteria? Well, this one lab value is out of sync. Okay. Is this something we could change the protocol for?- And start backing up a root cause analysis. This still gets you to your goal, still follows all the rules still, of course, protects safety, but is actually a conversation with a strategic plan right? Of how you're going to do it instead of what will they let me do. So let's just do that, right. Or let's just take the hit and enroll the ineligible patient and ask for forgiveness later. Um, you know what I mean? Like this creates an environment where there's some strife, there's gotta be a way to do this. There has to be, I mean, unless we're truly trying to do something nefarious, there's gotta be a way to do this and we're gonna figure it out and then we're going to pitch it and we're going to move forward. Um, and so it's, you know, it's just a unique background to have in that space. Um, and so, yeah, it's, it's, it's a blast. I love it. I can't say enough about how much fun we've had at first-class moving into this space, you know, and starting to kind of meld the projects together. And like I said, getting to bring in different subs in the area and starting to work with all different types of clients. Some you could have expected some you're like, Oh, I have a market for that. And then of course doing it in COVID, you know, I mean, I'm, I'm making my own capitalization Argument, right? Like I was making for my students of we're we're doing it, we're figuring it out. And, uh, and it's, I don't see it slowing down anytime soon, which is, which is fantastic. Um, because I just, again, you know, I couldn't imagine having this skillset and this desire and not sharing it with, with anyone and everyone who,
Brad: Well, I think, I think your, your energy comes through and your passion comes through. For sure. We're getting a little, a little long on time. I'd love. Well, I'd love to have you come back on and, uh, and you do some more. So in the meantime, tell people where they can find you.
Edye: Absolutely. Absolutely. So I am on LinkedIn. You'll find me under Edye Eden. I was going to say Edye T. Edens, if you look that up, it's literally linked in backslash Edye T. Edens. This, that is my go-to. You can also look me up on our company website, which is firstclasssolutions.Com. So firstclasssolutions.com and then my email. So that's my first name E D Y E period, last name E D E N S. And that's at firstclasssolutions.com
Brad: And, uh, we'll make sure we post that on the show notes, so everyone will have access. And, uh,
Edye: Absolutely. Yeah. We'd love to hear from folks and thank you so much for this and let me know, happy to come back and chat, do a deep dive and any one of the 500 topics.
Brad: It's not as bad. Yeah. We've got a lot, a lot, lot more. We could cover just, just from this conversation alone. So yeah, we'll, we'll set something up and again, I thank you for coming on.
Edye: Of course. Absolutely. Thanks so much.
Brad: Thanks Edye.
Edye: Bye-bye.