Launched in January 2025, the Association of Multisite Research Corporations (AMRC) was set up by its founding members to advance the adoption of multisite clinical research corporations (MCRCs) to streamline, speed up, and improve the quality of clinical research.
Jim Kremidas, Executive Director, AMRC, spoke with Christine Senn, SVP, Site-Sponsor Innovation, Advarra, about what motivated the creation of AMRC and how it is improving clinical research for trial sponsors. What makes AMRC unique is that all member organizations are focused on clinical research first and clinical practice second. They are not juggling two different types of business operations. These organizations hire people that are professionals at conducting clinical research, which makes them more efficient and boosts quality.
Watch the interview to hear more about AMRC’s mission and what challenges it is hoping to address first.
Transcript:
Christine Senn: Jim Kremidas, I am so excited to have you join us today to talk about your new adventure. Now, of course, you and I met when you were the executive director of ACRP.
Jim Kremidas: That’s right.
Christine Senn: Now you have some new fabulous thing happening, and I would love for you to tell everyone about it.
Jim Kremidas: Okay. Well, it’s another acronym. It’s AMRC, which is the Association of Multi Site, Research Corporations. And the reason we wanted to use that type of a name is we wanted to segment ourselves. We’re part of what you would consider a site network organization. Right? But these organizations are wholly owned. They own the investigator sites, and they have multiple sites around mostly the United States at this point. Some even have a few sites outside the United States. We have fourteen members currently, and we’re we may add a few more here and there, and we’re completely self-funded. The idea is to advocate for the benefits and understanding help people understand what some of the advantages are of using these types of organizations when they conduct their clinical trials.
Christine Senn: That’s great. And with fourteen organizations, I assume they’re always looking to add more. But right now, what are you looking to advocate for?
Jim Kremidas: Yeah.
Christine Senn: And I’ll say that I saw that on your webinar the other day, you had Doug Peddicord from ACRO there as well. So, it seems like you’re trying to build alliances.
Jim Kremidas: Absolutely. Yeah. That’s the thing is, you know, there’s so many opportunities for improvement in this industry. But the idea is if we could shift from a paradigm where sites are selected one at a time, you know, in various locations and contracted one at a time in various locations to a paradigm where you have a couple of organizations where maybe you take fifteen sites from each of those organizations. You sign one contract, and you get fifteen sites. You sign two contracts, you have now thirty sites. And if you need ten more, great. You select those. Maybe they’re academic sites. Maybe they’re individual sites somewhere that you really want to have a presence because of the population that practice attracts. So, it’s a little different way of looking at the business, and we think it helps streamline or will help streamline the, the speed and the and the operational efficiency of getting clinical research completed.
Christine Senn: That’s great. I mean, clinical research has become so expensive and it’s so complex. Are there any things that the sites are looking to solve at this point as a first problem?
Jim Kremidas: Already, I’m starting to hear some of the potential concerns that sponsors have.
Christine Senn: Okay.
Jim Kremidas: One of those concerns is quality, which makes perfect sense in terms of we are we’re all concerned about quality at all times. Their concern is that because these are held by for profit organizations, that perhaps there will be things that are cut back. I push back on that notion, but we have to prove that we do provide not only good quality, but better quality. And the reason is because we have people who are dedicated to certain roles, and the infrastructure is there, and we’re only focused on clinical research. These organizations or these companies are focused on clinical research, not necessarily clinical practice, So they’re not juggling those two type of business operations. They’re focused on clinical research, and they hire people that are professionals at conducting the various roles within the infrastructure.
Christine Senn: So I’m so interested. This group comes together. There’s always so much energy around initiatives. What are some of your first exciting things you wanted to conquer?
Jim Kremidas: Yeah. Great question. Well, first of all, there are two areas where we think we these organizations can offer benefits to sponsors, CROs, and ultimately patients and clinicians. And that is speed and quality. Okay? So with speed, one of the initiatives we would like to do is to prove that we can do things faster. You know, we need to get some data analytics around site start up timelines, first patient in, retention rates. What whatever the things are that are important to sponsors from a speed and operational efficiency perspective, we want to find how we can capture data that shows how these organizations function or perform relative to the what I’ll call business as usual, the traditional model of site selection and site startup. Okay. So that’s one. We need to get those data. The other thing we want to focus on is the quality of the work that they do. Because we’ve had some pushback about, you know, you’re a for profit organization, maybe you’re going to cut costs and cut corners, and is that going to lead to poor quality? Of course, our counterargument to that is, well, not really. Because if you look at it from the other side, these are dedicated research organizations. They’re not juggling a clinical practice too. The people they hire are professionals at each individual job. Of course, the PI, of course, the study coordinators, but also data management, quality assurance, etcetera, contracting, you name it. So, the infrastructure is there within these organizations. hereas, in other sites, it may or may not be there. There may be one person doing all of those jobs, if you see what I mean.
Christine Senn: Yes.
Jim Kremidas: So the point is we want to somehow quantify or show that in some type of a study as well. So those studies are the first things we want to do so we can actually prove our value.
Christine Senn: Well, I’m so glad you’re doing that. You’re trying to go for your processes being more efficient. Making sure you have quality or you don’t stay in business.
Jim Kremidas: Clinical research is a team sport. From the gleam in a scientist’s eye to writing the protocol, to selecting the sites, to executing the protocol, to analyzing the data, etcetera, you know, writing it up and submitting it. There are so many organizations and people who touch that process. And I firmly believe that as an industry, one of the things we really need to do is to streamline that entire process through better communication, through more professionalism in each of the roles. If you think about a football team, you know, you don’t ask the quarterback to play defensive tackle. Right? And you don’t ask the center to be a safety. I mean, you have to have the right people in the right role who are professionals at that specific role. And that’s one of the things we’re excited about with this new, association is our members, that’s exactly what they’re doing. They’re selecting professionals to fit in each one of those roles as it relates to the conduct of the protocol or executing the protocol.
Christine Senn: Yes. And I often see that these are the sites as well. Well, a lot of sites have, certified clinical research professionals. The coordinators and the PI’s and everyone else can be certified, and that’s another way of saying we believe in quality, we believe in knowing your ICH guidelines and following through. And it really is run then as a professionalization of our industry, which is what we’ve been working. You and I and many others have worked out for a very long time.
Jim Kremidas: Yeah. Very good. Yeah. Well, and it’s so part of it’s the staffing. Part of it is, of course, the infrastructure of the staffing. Part of it is the SOPs. The quality assurance within that organization. So there’s the personnel element, but there’s also other things such as technology and knowing how to use the technology. And just, you know, knowing how to interact well with patients. Building relationships with patients. It’s very important.
Christine Senn: Yes. So Yes. In fact, I think the sites that do that best, they have they have such great patient retention because they understand what it means to present yourself to a patient and how to help them through the process, and they are part of the bigger picture of clinical research.
Jim Kremidas: Yeah. For sure.
Christine Senn: Yeah. I love it. Well, thank you so much, Jim. I really appreciate your time. I’m so excited to follow you everywhere to see what happens with this group.
Jim Kremidas: Thank you. Well, we have a good group of folks, so it’s I’m excited as well.
Christine Senn: We really do. Thank you, Jim.
Jim Kremidas: Thanks, Christine.