Episode 15: Mario Sierra, Paramount Research Network
Mario Sierra has a background in biochemistry and business. He currently works at Research Source as a clinical research coordinator and Business Strategist at Paramount Research Network. I’ve had the pleasure of getting to know Mario outside of the podcast and he has a bright future in the clinical research industry.
In this episode we discuss his purposeful entry into clinical research, the adoption of e-source, and the slow adoption of technology across clinical research.
+Full Episode Transcript
Brad: All right, Mario. Thanks so much for coming on. Uh, I appreciate it, man.
Mario: Yeah. Thanks for having me, Brad.
Brad: Absolutely. So as I so often start with the pretty much everybody who comes on. Tell me a little about how you got into research. I know that you're, uh, you know, I'd call you a baby, you're pretty a new in clinical research. It's been what maybe a year or so officially, is that right?
Mario: So yeah, it's been a year in July. Yes.
Brad: Nice. So, yeah. So tell me how you, uh, how you got into it.
Mario: Sure. So I've definitely heard that question in some of your previous episodes, and I'd say I'm a little bit different because I actually sought out research as opposed to falling into it. So just a little bit of my educational background. I went to UT Austin and I majored in Biochemistry and minored in Business. And post-graduation, I was looking for something that merges business and science with a lot of research and just looking around at different job titles and all that, clinical research stood out. It stood out because it's exactly that it's a merge of business and science. We're working on the cutting edge of science, like investigating new drugs, new medical devices. And there's also the business end of it, where you're running an organization that runs trials in conjunction with doctors and different research facilities. So it ended up being a very good marriage.
Brad: Yeah. And actually, I, I kind of love the way that you came into it because it's very different, at least so far. And you know, everyone else we've had on that, you didn't start out at,you know, a university or a hospital. It wasn't sort of an accident that you fell into, Uh, you know, looking through your background, it looks like you, you went through the, was it the clinical research, fast track program?
Mario: Yes. Fast track was very important. Yeah.
Brad: Yeah. I'm actually, I'm kind of curious. I did talk, I've talked to other people who have either they teach, you know, or in do instruction is in it or have also gone through it. So I guess tell me a little bit about how that helped you, especially since you, I say you set out specifically to learn clinical research. So it looked like that was your kind of first stop along the way.
Mario: Yeah. So I saw that you had Jeannie Farnsworth on there and she was actually one of the instructors or she was leading the, the cohort that I had, this was last July in Dallas. And one thing I really liked about FastTrack is that they set you up. I mean, it's a crash course on research. So they, you go in knowing nothing about clinical research and you come out knowing all the vernaculars, all the ICF and IRB and dos, all these acronyms that we use in research, you come out already having a great foundation and knowing what the lingo is. So that way you can jump into the research side and whether you're at the site at an academic site, or even people get placed into CRO's and they do very well because they already have a knowledge base of research. And so it ended up helping me a lot to just hit the ground running and start enrolling trials and like already just so much knowledge it equipped me with
Brad: Yeah know that is a, that's awesome. And that's a, you know, oftentimes a barrier in the beginning, all the ridiculous acronyms that we deal with, uh, in our, in our industry. So yeah. Having to not be like, okay, what's an AE what's an SAE, what's an, what's an IRB? So yeah, that's that alone. Just having the exposure to all those different, all the jargon and all the different parts that go along, you know, obviously is the pattern I'm seeing with specifically with the clinical research fast track. So I might have to look into that myself for, for new employees. I'm glad to hear it was a positive experience.
Mario: Absolutely.
Brad: I also, uh, I really very much liked the idea that you recognized early on that, you know, clinical research does have, you know, there's a business side to it, which I think is oftentimes kind of underappreciated, especially when you come from a large, you know, if you're in an academic center, you're part of the department, you and your coordinator, you probably don't care that much about how much money clinical research is bringing in, but you know, someone like yourself, if you're entrepreneurial and are interested in science, then I think it's a perfect combination of those two things, obviously. Alright, so tell me a little bit about how that kind of brings you to what you're doing now?
Mario: Sure. So right now I'm working at two sites. So these are different research organizations. One is paramount research network in San Antonio. The other is research source in Austin. So there are two SMO site management organizations and we're embedded in one clinic at each site. We're trying to bring in more trials to make a full repertoire of research. And after that, the goal is to go branch out into new clinics and bring them trials. And these can be across different therapeutic areas. But right now we're focused on spinal medical devices in Austin. And then in San Antonio, we're doing a Nash trial and we're also branching out into some medical device there as well.
Brad: Nice. Yeah. And I always recommend as much as possible if you can diversify the more you diversify your therapeutic areas, kind of the better off you are. We know that GI is super hot right now, but you know, who knows two years from now that may not be the case. You might be stuck with, you know, PI that you can't get much done with. So, yeah. That's awesome. What have you, have you learned much as far as the two places do things differently and have you been able to sort of pick up some learning from that? I'm always, again, I know that everywhere I've worked seems to operate almost entirely differently. So do you think you've gotten some perspective from dealing with two different SMO's versus, you know, kind of starting out with just the one?
Mario: Actually, there's a lot of similarities that I see between both SMO's. Like they're both using E-source where I'm Creo at both sites. So I was able to take my experience and just plop it into the next site and get rolling with that. There is a different, there's a little bit of difference in the process, I guess, like with onboarding new trials. And I think that would probably be the biggest difference in the two leaders that I have. Just the process of finding new docs and finding new trials.
Brad: Yeah, no, I think that's great. I think you're getting, you know, some very diverse experience, like in the sort of beginning still at the beginning of your career, really. So that's going to benefit you a lot in the long run. I know that, you know, even for me and people I've talked to a lot of people sort of, you know, either wither in, again, these large institutions where, you know, you kind of do everything the same way forever and ever. I think it's really cool. And I'm actually really encouraged to see, you know, sort of a new, a new era of clinical research. People come up like this because I think that's, again, you're going to get, I think the best experience doing things like this and sort of a smaller, faster paced environment where you're oftentimes more encouraged to have to react and respond. And the fact that you guys are using E-source, you know, early on is huge. That's still, obviously not the norm. I would say across clinical research. I'm curious to know, do you guys have, were you there, is that was initiated or is that something you came in that was already in place?
Mario: So it was a process of finding different CTMS softwares to use at the site. We were looking at a couple of different ones and Creo ended up being the best option. So I was part of the process of deciding which CTMS to use. And on that point too. Yeah. When I was coming into this industry, it surprised me so much that a lot of industry runs on paper source still. I mean, those triplicate forms are maybe five years in the past. We're just now getting into E-source. And that actually fires me up a lot about getting into this industry, because that tells me that there's going to be a lot of opportunity for different software plays and different businesses to arise in this arena, similar to like the internet, boom, basically like we're probably 20 years in the past in this industry from what's happened around us, you know?
Brad: Yeah. No, that is that's. Yeah, you're absolutely right. And it's ridiculously frustrating and you know, a little bit just sad that what you imagined to be out on the cutting edge and research is so far behind. I mean, I can promise you, there are still a ton of sites out there probably even listening that are used Excel spreadsheets to keep up with, you know, their, their visits. That's fine. You know, that's not necessarily their, their fault, but just the fact that we haven't gotten there yet, that's, it's both discouraging, but the same time it is, it's going to be, I think a lot of opportunity for people to be able to do a lot of different things and a lot of different positions that will help integrate that. I'm kind of curious to know how that has worked for you guys on both like a, a investigator adoption as well as sponsor adoption. Do you guys see any pushback or issue from your sponsors as you're dealing with, or that basically saying, Hey, we use E-source.
Mario: So yeah, that's a great question. So I guess to transition into E-source, a lot of our doctors, I mean they use EMR, so those are electronic medical record. They're kind of used to using an online platform for, I guess, tracking their patients. But again, in the research perspective, we've kind of bridged it using some paper source and some E-source to make it more friendly for the doctors. So there are some paper forms that there'll be signing. And then a lot of the data that we capture, I mean, basically it's the coordinators that are using Creo and then our doctor is filling out a lot of paper forms and signing them there. And then we upload them to Creo, to show PI oversight and show that they are aware of what's going on their patients in the trial.
Brad: Nice. So yeah, I get a little bit of a hybrid. So a hybrid system at that point.
Mario: Exactly. And the sponsors. So during this COVID crisis, it actually benefited us to be on Creo because they were able to do remote monitoring. And that's something that a lot of sites have struggled with during this time trying to figure out how to find monitors or how to allow monitors to come into their site with these COVID precautions that are going on.
Brad: Yeah. And that's a good point. I mean, for better or worse, that's really driving some change and innovation in the industry because I mean, frankly, a lot of people won't come onsite, which has been a good thing. But if you're able to provide, you know, the ability for CRA's to monitor your data, you know, remotely, if that's, that creates a lot of advantages, really for everyone, again, you don't have somebody on site, you have to essentially sit with, keep an eye on all day. It saves the sponsor money. They're not having to send their CRA's out to travel and really the data is available to anyone who's got access to the system. So, you know, you can even have a different data entry person on your team who can access it on top of just the CRA monitoring. So it provides a lot of efficiencies for sure.
Mario: Absolutely.
Brad: So what does your, what is your day to day look like then as you're sort of splitting your time between two sites?
Mario: So, Let's see, during this time we've decided to have been on a freeze for enrolling patients, but we've been able to do more startup activities. So there's been onboarding two new trials at our Austin site and one new trial and our San Antonio site. So that's been a lot of where my focus is. There's a lot that goes into start up. And so it's not been so much seeing patients and enrolling patients into the active trials, but trying to get new trials into the sites that we have.
Brad: Yeah. Now it's definitely a good time to, if, if you're not, you know, really working your business development pipeline, in addition to that, you should be, you know, looking at your SOP is looking at your processes. There's a lot of things that can be done to help help you as you reopen. If you're not, you know, if you had to close, we've been pretty lucky we've, mostly been able to stay pretty functional, but it does, again, it provides a lot of opportunity to kind of, hone your processes. Have you guys started to see, I guess you have you seen a little bit of a ramp up here recently?
Mario: So yeah. Texas had a little opening. This was probably, um, three, four weeks ago. And then now Texas is in a spike of coronavirus. So everything is kind of going back to shutdown mode. We were able to enroll one patient in one of our trials and that kind of in between period. But yeah, we've gone back to a more remote model again, where we're not so much active at the site and yes, like you said, we can definitely use this time to refine the process whenever you have a lot of patients coming through and you're trying to just follow them. It makes it harder to step back and look at the process as a whole. So that's what we've taken this time to do and capitalize on that.
Brad: Yeah. It's, it's so often very sort of feast or famine. So, you know, as you're enrolling at trial, it's, I mean, that's taking up a lot of your time and resources. So, uh, occasionally it's kind of nice to have the extra time to really stand back and get a, get a look at the bigger picture and kind of get your ducks in a row. So, I mean, I hope that's, uh, something that sites are really taking advantage of as much as possible.
Mario: Absolutely.
Brad: So in your, uh, you know, year or so here of doing this, what are some best practices that you've kind of picked up along the way? Hmm.
Mario: That's a great question. Let's see. Best practices. So I would say using software to leverage my work is one of the best practices that I've seen. So what I try to do at our sites is find softwares that allow me to offload some work. So for example, I mean, Creo is the prime example where we're able to use that to collect data online. But another platform that I like to use is called Slope and this allows us to track inventory. So we upload all of our inventory. So when you start a new trial, say it's a drug trial, you get all these shipping boxes, all the kits to draw blood and so many different moving parts. What we do is they upload that to the software to Slope, and that allows us to monitor it remotely and not have to be at the site and do a physical inventory of what we have. So that's been a very good practice that we implemented before COVID started and it's helped us manage things throughout this crisis too.
Brad: Yeah. And that, that is a good, that's a good one. I actually just recently interviewed, uh, Ethan from Slope by the time this comes out, I think his will release a week before yours. So yeah, there's a, we talked quite a bit about Slope and I do, I do really like what they've done. It's a pretty, uh, I thought it was a really interesting and smart thing to capitalize on and build a platform around for a site level because it's something that you so often don't really think about, but I can't tell you how many times I've throughout my career. If I've gone to find a lab kit only to be like, Oh, well this expired a week ago. So that clearly helps. Yeah. That's a really cool, a cool tool, ah Creo. We use Creo as well. I really like Creo and I'm kind of sad to say that we haven't utilized the E-source as much as I initially intended to. Uh, just because when we started getting hammered with new study opportunities and you know, you're starting out, it was tricky for us to kind of manage that process of building the source and making sure we're doing everything, you know, really well and efficiently. But yeah, I do love that. I like to use HubSpot, you know, to track all my study leads. Some kind of CRM I think is like smart for sites to use. I don't feel like I've seen a lot of sites who really utilize, uh, some kind of CRM to track it. But yeah, I think that there's a lot of software out there that's maybe not meant for specifically the clinical research industry, but can easily be leveraged to help us do our jobs better and stuff besides, you know, Excel and word.
Mario: Yeah. Uh, one of the things that kind of drives me crazy about research is that we collect one piece of information and then we have to put that piece of information in 10 different places. And so that's exactly what software is good for. You collect your data and then this data is shareable to other softwares from my platform. And that's exactly what, um, any Creo is getting there and things like Slope are helping in that process.
Brad: Yeah. I'm really curious to see how sponsors, I mean, I've got to think it's gotta be driven from the sponsors at some point to get some more consistency across cause you're right. I mean, it's, it's crazy that, you know, we're using three different systems if you're lucky for each, for every study and none of those things seem to really communicate well to each other. And then, you know, every sponsor uses their own has a lot of their own proprietary stuff, which just creates more confusion and less, they're just less efficiency. So it's, it's, it's insane.
Mario: Yes. And then in the year that I've been doing research, I've had probably 20 different logins now that I have to keep track of different EDCs and different platforms that each sponsor is using. So yeah, it definitely gets very chaotic. And the more trials you have, the more logins and the more passwords and the more accounts you have.
Brad: Yeah. That's easily one of my most frustrating things about it. And if you don't use last pass, that's, that's my, a little piece of value I'll throw out there that anyone listening my checkout last pass, that it'll help kind of carry your logins across any system that you use. So you have one login that stores all your passwords, but if you create a password on your computer, it will be available on your phone if you use it later. So I love that because I would not be able to log into anything if I didn't have something tracking it for me.
Mario: Absolutely. Yeah. And then these, these softwares, they make you reset your password every 14 days. It seems like there's that.
Brad: Yeah, exactly. They don't make it. They don't make it easy for any of anyone. So, uh, what are some other resources you use this sort of in your day to day that, uh, you might share with the clinical research community?
Mario: Another resource I use is Asana, that's what I used to track, I guess, tasks that I have to accomplish during the day. And you can even go in and set it up. So a certain visit. I mean, there are certain tasks that you have to complete in a visit or the way I've done it is put all those tasks in a project, in Asana and then make sure that they're all met check, check, check, and then they go away. And then that way I know that I've conducted the visit to protocol and that eliminates some deviations and all that. So that's been a pretty good resource.
Brad: Yeah, no, that's awesome. We also use the Asana say a lot of our team's sort of a decentralized, so we use Slack to communicate and then Slack has a nice integration with the Asana. So if I'm a, you know, if I get a study lead, but I need to pass it, pass it off to somebody to follow up on, I can sort of work it all through Slack, but Asana will track the process of that working that study lead. So yeah, I, I very much, uh, also endorse Asana. I use it more for the study startup process than anything, but yeah, that is another awesome. I'm glad to hear, you know, again, people using these different tools and sort of making it work for you again, none of that's specifically meant for clinical research per se, but you can, you can sort of utilize it to your advantage
Mario: For sure. Yes, definitely. I definitely try and find any software solution that makes, makes the process more streamlined and makes it so that we're, we're keeping on track with everything. For sure.
Brad: Yeah. No, I love that. All right. Well, very good. Well, anything else you want to add before we kind of wrap up here?
Mario: No, I think we covered, we think we covered some great topics and it was a great interview. So thank you. Yeah, very good. Where
Brad: Can people reach out to you online?
Mario: It's active on LinkedIn and you can find me there. And then our website is for our San Antonio site, the PRNLLC.com. You can check us out there.
Brad: All right. Very good, Mario, thank you so much for coming on, man. I appreciate it.
Mario: Thanks Brad.