Sites at the Center: Lessons from the Global Site Solutions Summit

Mohammad Millwala, CEO of DM Clinical Research and 2025 Christine K. Pierre Impact Award recipient, joins SCRS Honorary President David Vulcano to unpack the most pressing challenges clinical research sites are navigating today.

New findings from the 2025 SCRS Global Landscape Survey show protocol complexity topping the list, persistent communication gaps affecting most sites, and ongoing difficulty connecting with patient communities. Together, these leaders offer grounded solutions, including using risk scores to evaluate protocols, tapping existing healthcare infrastructure for recruitment, and rethinking assumptions about research-naive investigators.

Listen now for a clear view of what sites are really facing and the ideas gaining momentum across the industry.

Transcript

Jimmy Bechtel: 0:00

Well, welcome everybody. My name is Jimmy Bechtel. I'm the Chief Site Success Officer with the Society for Clinical Research Sites. So really excited to have Mohammad Mill Walla, who is the CEO of DM clinical research and David Vulcano, who is our SCRS honorary president and also serves in an executive leadership role within HCA healthcare here to talk with me a little bit about a recap from the Global Site Solutions Summit that we held down in Orlando, Florida, record breaking over 1900 individuals joined us at that conference and wanting to talk a little bit about solutions we hear a lot in the industry. And serving as core to the work that SCRS does and part of our mission is to perpetuate solutions into the industry. We're not here to complain. We're not here to witch as Christine, our late founder, used to indicate we are here to solve. So if we come to a forum like this Global Site Solutions Summit or any of our other forums, we always want to come with possible solutions to work together and try to solve some of these challenges. So again, it's my honor to be facilitating this conversation here. It's going to be very conversational between Mohammad and, and David and myself. But one of the things I wanted to kick us off with and highlight is our hashtag one thing challenge. What is one takeaway that you've gained from the conference if you were able to attend, what is one thing that you have gleaned from this year as a clinical researcher? What is one connection that you've been able to make that's maybe had a really big impact on you or one big change that you made? What is your one thing that you want to perpetuate? So there's one plug for some future opportunities to help bring some of the message and some of those solutions home to all of us. But with that. For those of you that were able to attend the summit, you are likely aware that Mohammed is the most recent recipient of the CKP award. Our Christine k Pierre lifetime Achievement Award. And Mohammed you've joined quite an elite list. David is actually the first recipient of that award, so we have this year's most recent and the very first, but you, Mohammad, I wanted to start with you. You've had maybe a few minutes for the shock to come down and to process what that means for you and what that means for the award and really what it means for the industry. Christine was such a powerhouse in the industry, which is why we created this award for individuals who really continue to personify her message and her vision that she had when she founded SCRS. And started the Site Solutions summits to really make change and amplify the voice of the research sites and those that have received this award, again, personify that continued mission at SCRS. and we do this to honor her, but also honor those of you that are leaders in this space. So talk to us a little bit about what that means to you and, what's been going through your brain now that you're on the receiving end of it.

Mohammad Millwala: 2:47

So thank you, Jimmy. First of all, thank you to SCRS and, the award was a complete shock to me. I was overwhelmed and I couldn't even talk. I can usually talk very much a lot. I, I knew christine, in the early days of the SCRS formation, and even before that when we were Site Solution Summit she could see far away the importance of sites And the collaboration that the sponsors and CROs need to make with sites. it's, and today where we're at the industry's at is a lot because of her, I feel the touch points that sites have now with sponsors and CROs we couldn't have gotten that voice. We couldn't have gotten that stature, the site connectivity to her sponsor and CROs, I mean, she had an amazing vision. And not only did she have an amazing vision, she actually did something about it. she talked to sponsors, she made things happen. She told them about our problems. I mean, even if we talk to sponsors today, some sponsors have never walked in a site and she was able to explain to house what site faces and what they need to do for sites. So I think getting this award. Is, almost like a miracle for me, Jimmy. it means a lot. her commitment to the work her mentoring that she did to me, I mean, she had no stake in my business yet, for an FDA inspection. She called in advance and said, you know, Hey, Moham, how you doing? You don't say this to the inspector. You do this because, this was my early days. she was the only one that could explain to me what the business of sites, we didn't really have resources back then. As to how do you run a site profitably and sustainably, so attaching her name with, DM and with my name is truly an honor.

Jimmy Bechtel: 4:26

Yeah, that's great. Mohammad. Yes she did, that forward vision is really something that is rare and unique in the industry, and she certainly had that. She was able to see a few steps ahead and paint stories, tell stories with data and information and really advance the work that the sites are doing. So thank you. But David, I want to go to you as well, having been on the receiving end of this for so many years now, it was roughly, I believe, five years, maybe six now, that you initially received that award. And you've done countless amazing things, not only in your career, but also in service to SCRS as our honorary president perpetuating that vision and mission. But, maybe talk to the seasoned CKP recipient here and what that means to you as well.

David Vulcano: 5:10

Well, thanks Jimmy. You know, welcome Mohammed. thrilled to have you as part of this. Well-deserved over your career and all your accomplishments. I mean, I too was surprised in getting it. You know, I didn't even know that this was an award that was being handed out and I'm in the awards gala and I'm hearing him talk about this new award and talking about this person. I'm sitting there thinking. Man, I've done a lot of that stuff. I've done a lot of this stuff, man, this would be a cool award to win. and then of course that happened. But you know, the namesake obviously, of Christine Pierre being the founder of SCRS, I knew Christine when we were on the board of directors for A CRP together, and she had left to form the Site Solutions Summit and SCRS and invited me to be part of leadership of it. And I told her, Christine, good gosh, there's so many initiatives that are trying to do the same thing that you're trying to do. You know my time's valuable, how do I know that you're gonna do this? and if anybody knows Christine Pierre, you about know how that conversation went, right? I walked away with my tail between my legs. so I did join and, truly the honor of that CKP award, is, you know, I still see it as a job and not a trophy. it's a great award, but it still is a job. I still have my professional tithing on that. I'm not resting on my laurels on this and inspires me all the time to embody that passion and that vision that Christine had and Mohammad about doing things. So we need to keep accomplishing things. My passion, what I'm trying to bring to the organization is obviously make sure the sites operate as a business. Mohammad said it, well, it's great to do a study, but if it's not a sustainable business, you're gonna be a one and done. And it's an injury to the site, injury to the site industry, and it's an injury to medical progress and getting. Products to patients and their families so that they can live longer, happier, and healthier lives.

Jimmy Bechtel: 6:52

Excellent, David, thank you as well. And, extending my congratulations to you Mohammed. it is really empowering and I hope inspirational for those that are listening continuing to play their part and contribute to the community.'cause it is our voice and our community. That's been the motto of SCRS since its inception. And every single site that contributes to that and stands it up and their own unique ways really are part of that. And you. Serve now as leaders in that space to help amplify and bring that voice together. So, thank you to both of you. And of course again, congratulations to Mohammed. I wanna shift gears a little bit and continue this, thread on that theme of inspiration and drive and passion. So, David, maybe you can start us off sharing a little bit about maybe a conversation or an interaction. A collision if you will, that might've inspired you or something that you've taken back and you really haven't been able to let go of since the summit, that's really kind of driven you these past few weeks.

David Vulcano: 7:49

Jimmy, I think it was the overall vibe of the event that a few conversations or comments that came to me. I was asking a lot of new sites. We had, a great percentage of the new sites that have come to the summit as they do every year. And I asked a number of them, well, how did you hear about it? I'm starting to hear things from a couple of sites that say, Hey, the CRO told me about it and told me to come, which is like, wow, that's fantastic that CROs or sponsors are now talking to sites and saying, Hey, you should go to this event. It really spoke to me about our global impact partners that are there to make sure that the sites are successful in running their studies are now seeing the value of the sites. I mean, they may have before at various levels, but they see the value of this organization and what we're trying to accomplish and saying, this is a meeting that you should go to in order for you to do your very best for me. So I thought that that was fantastic that I've heard more than before about how, hey, the CRO told me to come, or, or a sponsor told me about it. Some of'em have heard from other sites. Great things like, man, this is a great meeting I'm coming to. Every year. Right? Or this is the one conference I go to, this is the best one. we do it like nobody else. but it really was true to me that, that you know, filled my tank about that comment. They had a gentleman that was there that also filled my tank as, as the saying goes. That said that he attended one of our sessions last year on workforce initiatives, It was a costume thing. I dressed up as a UPS worker and he had said that session really stuck with him about trying to find new translatable skills, and finding people outside of the research industry and bringing them in. He went out, hired somebody. They're killing it. This person is doing fantastic and he just wanted to come up and thank me. He says, that session that you have really inspired me to go out and do this. They actually got a grant from ACRO to help support this individuals do some work in some diverse communities to help community building and things like that. so I see not only the vibe and the excitement that create, but the longer term dividends that our conversations and our initiatives are bringing.

Jimmy Bechtel: 9:56

Yeah. Several excellent points there, David. It is really inspiring and interesting to see that unique aspect of our community and our event around the fact that the sponsors want to use this as an opportunity to engage with the sites and learn from them and converse with them. It is, very rare. In the industry it, seems to be something that passively happens, at a lot of other spaces, but for the fact that there are sponsors and CROs saying, you are our partner sites and we want you here to have the conversations and we have great things to share with you, is really, really cool. and again, not. Something that we see in the industry very much. But Mohammed, I wanna shift gears to you now as well and ask the same question from your perspective, that conversation, that collision that you might have had or that opportunity that's continued to reinvigorate or derive you forward, maybe even double down on something that you've always believed in.

Mohammad Millwala: 10:46

So something Jimmy that I that I got out of this is, sites have a greater voice and there's a lot of opportunities for sites to do more things. But that's my takeaway and my learning from what I need to do in my organization. But another thing that have really humbled me, similar to what David mentioned. Is that, there were individual site owners, or maybe they had two, three sites that came up to me, you know, when we were by the booth or just in the hallway and said, we had attended your session in the past and this is what we, and now he's running a site, little small night site network of$2.5 million, where he was once a coordinator and he attended a session and he said, you know I never knew what I'm gonna do. And now he's a business owner and that is the impact we make, right, as a collective group, as a forum. It's just phenomenal. It is absolutely life changing. that guy that was brought in, David at the other side that you're mentioning, I mean, he's gonna have a very amazing career. Research is a great career for a lot of folks. You never know if there'll be entrepreneurs and this gentleman came up to me and I'd forgotten about my conversation probably a couple years ago with him. But now he's running a$2.5 million business and majority of that is oncology. I was completely floored and i think remaining positive with the site owners is a key, right? There's always challenges in life, in business. There's all, but there are a lot of opportunities and we just look to focus on those opportunities. I think one of the biggest things that I've taken away from SCRS personally, Jimmy, is. Transparency and sharing and collaboration. The whole positive vibe since day one of the conference,, over several years. If we just continue doing that and then also continue the message saying, even if you're a single site, that's okay. You know, every good site has a place in this universe. You just have to be a good site. You do good work, meet the goals, good quality data, good pi, oversight, all the fundamentals, and you'll always be in business.

David Vulcano: 12:39

Mohammed, that that said a lot about that sharing says, it just never amazes me how generous sites are with each other because, sure we, we compete a little bit, but the macro stuff, we very much focus on the rising tie that lifts all the boats. You know, our enemy is cancer. Our enemy is technology congestion. Our enemy is greater than us. and yes, we may have some things where we might compete with each other but we see more in collaboration in working with our common enemy of cancer or common friction of. Budgeting processes and technology congestion and things along those lines There was one other thing, Jimmy, that occurred that really jazzed me. And that was one of our sponsors did a session one of the opening, preliminary sessions on it.

Mohammad Millwala: 13:25

Symposium.

David Vulcano: 13:26

Yeah, the symposiums. Thank you. Thank you, Mohammed. And you know, they came there and they did one last year and they came there this year and it says, Hey, sites. We talked about site payments last year on this. We heard loud and clear from you guys that we need to pay you guys monthly. We need to not do holdbacks. And, and we took that. Here's what we did. We eliminated quarterly payments. We switched to monthly. We eliminated holdbacks, we addressed our screen failure. You know, we, we've eliminated screen failure ratios. Thank you. That's what we've done based on your feedback last year. This topic and we'll come back to you next year and show you what we did. it just showed the sites. We are listening to you and we're not only, we just listening to you, but we're taking this information back and taking action on it.

Mohammad Millwala: 14:07

And, and David, you're absolutely right. I was completely surprised with the directness of the actions they'd taken. You know, it wasn't fluffy at all. They had done it already. They didn't say we're working on it or, you know, it's gonna Right. They changed the systems, they did everything and they just made it happen. I was just phenomenal.

Jimmy Bechtel: 14:23

Yeah. Great points gentlemen, and really. Mohammed, honing in on the opportunities that the community can help you with, should you be able to embrace them, because it's twofold from what I heard from you, it's not only the skills and learning, bridging the gap in how to run a business, how to run effective site budget and contracting training, et cetera. Right. Numerous opportunities for that educational component there, but also learning from other individuals. That mentorship aspect that happens at the summit to hear. I can do this. Other people have done this. I'm not alone in my opportunity to make these things happen and make this change or take that step and advance this and that to can be, David, you gave examples too that can also be applied to the, I'm not alone. The sense of community is probably a better way to phrase that in what we're asking for and what the challenges are and really unifying around those. some great messages there from the both of you on what the value you can get from the summit and what you bring back to your organizations. So moving now to talk a little bit about the challenges and the solutions we're very solution oriented as we've mentioned here at SCRS The touchstones that we have at the summit that helps us understand some of those tactical challenges and potential solutions for them is the site landscape. And we had the opportunity to deliver that data this year with Ken Getz from the Tufts center for drug disease drug development. Ken Getz, we all know him. We all love him. He does an excellent job, he and his organization with data, and we were able to co-present that this year and took away a few really, really important data points. Some of them are, I would say unfortunately, consistent year over year, and I wanna talk about a little bit of those. But other ones were very insightful and sort of new data that maybe we hadn't seen in previous years before, but one of those to kind of warm us up and get us into this space here. Is that idea of communication pathways. We see that over 60% of the sites through our data report that the communication pathway, that channel of communication feedback loops, having one point of contact. The examples here are numerous really is a key pain point for the sites and effective communication. And one could make the argument very easily that if we solve some of these communication pathways challenges, some of these other. Issues that we see in the industry would probably solve themselves or be less of a burden and be able to be anticipatory, the solution outcome of this is numerous, which is where, I'll go to the two of you, Mohammed, maybe start with you in this area as well. Hearing those numbers, hearing that communication continues to be a challenge, maybe contextualize that in terms of your organization and talk to us about. Some things that you've done right? I'll get up on stage any day of the week and say and attest to the wonderful productive site that DM clinical research is. So maybe give some examples of where DM has either been able to solve that or where you hope to see solutions be implemented. Again, along that concept of communication.

Mohammad Millwala: 17:24

So Jimmy, very valid point. And I think navigating the sponsor world or the Pathways, multiple pathways, communication pathways that they have, and figuring out what pathways to, to go on is certainly a challenge. However, what they've done for the networks or the group of sites or however you call it they have, most sponsors have now put in some put in place. A representative, if you will. So that's, and CROs as well. So I think they're making the moves. But individual sites may be still struggling with this, so we need to still figure that out. the ROI is what we need to explain to the sponsors. what we do is we say, look, if we can get one connect, this is what the value we're gonna offer to you. Because if they're investing in resources, we should be able to also justify why should we get that resource right? So what we do is we do case studies, we update, we are very transparent in what our planning needs to be for their project. So they get a lot of value from us that they would typically not get. The challenge is these representatives are not the ops team. The ops team is still different. So it's very hard before a study or program starts to disseminate this information to the program team or the project team, but it's still a beginning. the project team still sits in a different vertical. this site relationship partner sits in a very different vertical, but it's still a pathway. I think the best scenario would be if we get a wholesome approach of talking to the project team or the ops team, because that's really where the study's conducted. from a pipeline standpoint or the work and the communication, the relationship standpoint, I think sponsors and CROs have made changes and are improving. and it's going the right direction, Jimmy, but there's still a lot of work to be done.

Jimmy Bechtel: 19:08

Yeah, excellent point, Mohammed and I really resonate with the example that you gave around not only having a singular point of contact, but that concept of a KPI, if you will, around that space, right. We know it's never a good idea to make demands of our sponsors and CROs for the sake of a demand or an ask to put it a little lighter maybe. But without being able to help them understand as to why that's important and what value that brings to not only the clinical trial execution process for that particular instance, but anytime we can draw, make those lines clear to our sponsor and CRO partners, the easier it is that those asks can come through. But shift to you now as well, David, when we talk about communication pathways, and again what maybe you're seeing or hearing from our constituency that you're very involved in and what's maybe solutions exist or should exist.

David Vulcano: 19:56

Communications is, it's, it's a chronic issue. I remember 25 years ago I heard a gentleman give a presentation on communications, and he said, 10 years ago I gave a profession on communications. And I predict 10 years from now that I'll still be giving a talk on communications. But nevertheless. the communications is key obviously for study success at the site level. yes, we need to communicate information to the sponsors and CROs and our solution providers that, may have challenges or troubleshooting or things along the lines with their solutions, et cetera. But the key thing on communications is, is that the sites need answers when the sites need the answers, because we need the information when we need it. When we need information is when we have the participants sitting with us saying, my e diary isn't working. How do I do this? So we need to be able to get that information in near real time. And technology, I believe is a good play in this, in that we're communicating something out. So we see institutionalizing knowledge through technology both within ourselves at the sites as well as our preferred sponsor and CRO colleagues whose studies we prefer to do and excel at. In more institutionalizing and or embracing technology to institutionalize knowledge that needs to be shared across a variety of things. But AI is Also helping a lot with trying to improve those communications, whether it's triaging, communications, chat bots that can answer simple questions or working things that, prioritize communications or summarize or things along those lines.

Mohammad Millwala: 21:28

So the idea is operational execution, right? And we need communication. And I think we do a lot of work on study startup, the milestones, but I think there needs to be very defined operational execution things by sponsor and maybe create an ecosystem for a study or a program. And there's a wholesome communication module. Not a portal, but maybe chat bot or you know, some solution You, David, absolutely right. When a coordinator needs someone and they don't get'em, and then the patient is a screen fail. Not only did we lose revenue, but we now. kept this person away from a research study where it is his or her right to be in that because they did qualify. So, we're actually breaking ICH rules. So I think there's a greater, look from a altruistic macro level, if you will.

Jimmy Bechtel: 22:18

It's an excellent point. Mohammad and David and what? I hear from that. Just to kind of summarize that point that you both made is we need to move from an era of technology being a hindrance because David, you gave the example of a piece of technology that was a hindrance to an era of where technology can enhance and enable. And build that communication. But I think what's really important for sites, Is when they're being asked to use a piece of technology, is ask themselves the question, how is this technology going to improve the communication and the interaction that I have with the patient, or what needs to change about it for me to be able to do that? It's what do I need to work with the sponsor and or CRO and or service provider to be able to enable that, but also then what internally do I need to do to be able to facilitate that implementation that, that, that integration in mind, because again. The core question is how will that support communication, whether it be, again, with a sponsor, CRO service provider or industry side, or with the patient, it should enable that process and not hinder it. Moving to trial complexity here I think we could easily make the argument that trial complexity can be less burdensome. I wouldn't say it's not gonna solve it, but it would be less burdensome should we have those effective communication channels open. Ken's data really honed in on this. We're seeing more endpoints in clinical trials. We're seeing stricter and more eligibility criteria. We're seeing more procedures, you name it, there's just more, the pages of the protocols continue to get longer and more numerous. Bottom line results in more frequent protocol deviations as a result of this. there is no arguing at that point, regardless of how you wanna spin it. There's a lot more that goes into that, of course. But it is very easily to correlate the trends of the data with more complex protocols to more deviations. Despite our best efforts there. And this year we saw it was the number one concern for the landscape. Survey takers, protocol complexity. In the past, we've seen, training has been the number one concern, and workforce has been the number one concern, especially coming out of the COVID pandemic, This year, the concerned du Jour was protocol complexity and what we're seeing at the site level. So, I'll start, I'll go to you first, David here. Again, share with us protocol complexity, but then, you know, contextualize that again around solutions as well.

David Vulcano: 24:34

Sure. Yes, the trials are complex. The four corners of the protocols are becoming more complex, but also the execution of the protocols. It's not just the four corners of the protocols that are getting longer, more endpoints and things like that. It's everything else. In executing it, it's the technology add-ons, the five or six e thingies that are added onto it. how is it gonna be done in a healthcare environment if it involves blending routine care? Is the routine care available to us to do this, how do we get the genetic testing on that? I mean, down to, oh my gosh, I have to plug this in and send in the EKG. But my hospital has blocked international numbers from being dialed out So just everything in that complexity, our good friend Vivian Vanderwal says it's like an escape room that the sites have to do to get a visit done nowadays. As far as the solutions, a wide variety of things are key. If you look at the four corners of the protocol, we're hearing a lot about site and participant input into those protocols. The revision three of the gcps clearly safe that sponsors should be getting more input from other stakeholders about the realities of the do abilities of these protocols. So yes, let's not start with the old protocol and add to it. Let's start with zero and see what we can eliminate from the old protocol rather than the copy paste and add type methods of the four corners of the protocol. We're starting to see a little bit more interoperability with the tech. We're not quite there yet for full interoperability, but we are starting to see some of the technology solution providers cooperate with each other, open up so that data can be shared across each other, single sign-on systems, all of this other kind of stuff that will definitely help with some of that complexity

Jimmy Bechtel: 26:24

Great points. The reality is. that protocols are becoming more complex. Now, it is driven in large part from, what our data's showing us and what we're seeing by the nature of the conditions that we're treating, the diseases have become more complex. Their mechanism of treatment has become more complex. Therefore, the protocols themselves have become more complex. So, to your point, David, it's not necessarily making the protocols less complex. It's managing that complexity is really where we need to put our focus around and how we. Not only budget for that complexity appropriately and not continue to assume that our protocols are not complex and throwing these misaligned budgets over the fence to the sites, assuming that everything's gonna be just as easy as it was 10 years ago because it's not, your protocols are longer. How could you possibly believe that that's gonna be the case? So not only from a budgetary, so the sites can. Finance and capitalize on that complexity and manage it appropriately, but also all the other things that go with that, like you said, the technology and, appropriate fit for use execution of those protocols. So David, thank you and I'll shift to you, Mohammad, for your perspective on complexity here.

Mohammad Millwala: 27:33

So David, great points. The industry is really trying to figure out the recruitment part of things, right? And have new vendors, new avenues to have access to patients. We're making progress there, but it still remains an issue. And this is a new issue that's come up, this protocol we've been talking about for several years now. But I think clinical trial execution is a new chapter that we need to voice about. the protocol complexity leads to poor clinical trial execution, right? So clinical trial execution should have some KPIs. So what we do at DM, Jimmy is we don't call it protocol complexity, but we assign every protocol we take on a risk score. So I have a fear of failure. We wanna be successful, right? the opposite of success is failure. So we avoid failure, we'll be successful. So we have a risk score that we assign every single protocol and the risk score of protocol could depend on every site we operate that protocol in. Because the PI may be more experienced, the staff may be more experienced. So all of that combined has a risk score for that program, for execution basis. Protocol complexity is certainly a clinical execution risk. And so now we have two compounded problems. We have slow recruitment, right? And we have protocol complexity. and one of my other solutions I would say is every sponsor project management team should have a experienced site guy as part of their team. So they know this complexity is gonna ruin any good site. Then why are we creating such a problem?

David Vulcano: 28:55

and Mohammad, you are a very experienced and sophisticated sites and if organizations like yourselves are saying This protocol is getting too complex to run, can you imagine the impact on us grooming the next generation of investigators? Yeah. Who are coming in and doing their first protocol and trying to get something very sophisticated sites are challenged to do. where you get scale is where you reduce variance, right. Reducing variance leads to higher quality and more scale. If I have 20 different things that have to be in concordance, you know, if the protocol is amended. Well, did the lab manual get amended to, did this instruction manual, two? Did this other written instructions in the clinical trial agreement get amended in this concordance?'cause, so oftentimes we hear from sites that, well, the protocol amended, but now it's inconsistent with the lab manual. Or it's, this technology thing doesn't embrace what the protocol is trying to do, so we need to do a workaround on this. So the complexity is leading to more deviations as well as problems when you're trying to fix those deviations. Our good friends and colleague Dan Oap says, Hey, we need to slow it down to speed it up.

Jimmy Bechtel: 30:16

Exactly. Excellent. David and Mohammed, thank you for that. I there should be no reason why when we don't get that protocol, that we don't conduct our effective risk assessment and really understand what type of commitment that that clinical trial is going to require of us, and then how that ultimately will affect patient recruitment, which is where I'd like the last topic I'd like us to focus on today and where I'll shift our direction here to conclude our conversation is that concept of patient community access and our data here really does continue to show that this is a major focus at the site level for the purposes of recruitment. And 36% of our community says that this is something that they're really wanting guidance, help insight on how to do this because we know. the data that Ken was able to show through his portion of the data here, he spent some time on patient community access. Is that when we employ technology on our clinical trials, Ken's number was something around 160% enrollment improvement when we are able to successfully implement technology on our clinical trials and enable that patient community access. Mohammed, I'll start with you. I, you've been a long time supporter and really insightful into the work around patient community access. I know that is a core value and functionality of the success and what drives DM is putting yourselves into communities that value and, can. Take advantage of and benefit from clinical trials and clinical research, so talk a little bit about, that challenge and, the solutions in the space that you've seen successful.

Mohammad Millwala: 31:49

So Jimmy, when I started 20 years ago, I think the number of clinical trial participants were 3% in, in the nation, and I don't think we really moved the needle. It's probably around the same, I haven't checked the numbers, but it's not more than 5%, I'm pretty sure. So how do you scale this, right? Jimmy, we have to figure out how to scale this and we've gotta use our machinery that we already have in healthcare sponsors already using it. I mean, yes, sites can do a lot of stuff. We can do engagement in the communities, but we are only doing engagement in the communities we are existing in, right? Even if you look at 10,000 or 20,000 sites that are probably in this country and globally there's more sites, but you'll only impact in your local region, that's still great. But sites maybe the 10 or 15 networks, they'll have more resources, but the others don't. Right. The majority don't have resources and the sponsors have the machinery. For example, I was talking to a sponsor. I said, can we just give your pharma sales guys, the commercial side? Just t-shirts to the physicians saying, help research refer patients. That's all you have to do. They don't have to say anything. I mean, we have a whole machinery and I don't think we're using that machinery successfully to promote research. I think the physicians is where the trust lies and, yeah, you've got news, Facebook and all the social media advertising. But when you go to complex therapeutics, you need the physician trust. If my rheumatoid arthritis or my PI doesn't say This guy needs, biologics, that's, an a CS study, they're gonna work only with their cardiologist unless their cardiologist says, Hey, down the street there's a research center. That I know does a good job. That trust factor is key and we need to get the HCP involvement throughout the nation to make a change and to make, that's my take on this.

Jimmy Bechtel: 33:35

Exactly, Mohammad and you're right. A site is a relatively isolated voice. When we talk about the global awareness of clinical trials, they're in certain communities, they're reaching them through their local health fairs and maybe local TV ads, right? We don't have any large scale awareness campaign. I mean, call it what you will. And, you know, the COVID Pandemic was a heightened awareness around clinical trials and vaccine development specifically for us. Right. And that was a global, a global incident. We did see a little bit of awareness around the clinical trial process. And unfortunately, most of the media presence and the news that we get around medicine and clinical trials is oftentimes unfortunately negative. Right? And it, It's hard to dispel those myths and those inconsistencies or the half-truths or the frank lies But to your point, Mohammad, how do we solve, right? This is a question for us as an industry, how do we solve raising positive awareness? Yes, at a large scale for the clinical research enterprise, so that, again, we raise all boats david, your thoughts on this concept of community engagement as well?

David Vulcano: 34:42

I'm not sure I have much more to add other than just reinforce the fact that this is a long-term investment. this is not one where we just walk into a community and everybody turns on a dime and then, everything happens. That's long-term investment that sites and sponsors and other stakeholders have to make in these communities. Sites that are doing this successfully will tell you this is a multi-year event. We have to go in, not with a study, but we have to go in and be the education about diabetes. We have to give the free blood checks, we have to do all that kind of stuff. These are challenging things to do for a variety of legitimate and not legitimate reasons, but for some legitimate reasons on a study by study basis, or a sponsor by sponsor basis on doing this. So I think this is a issue that is meta.

Jimmy Bechtel: 35:29

Mm-hmm.

David Vulcano: 35:29

and not gonna be focused on in the micro worlds. The other thing too is that we have to start giving chances to these physicians and other non-physicians in these areas that can be investigators that already have the beginning of the trust. You know, Stephen Covey Jr. Wrote the book, the Speed of Trust, right? You have trust first. Speed comes second. Yeah, we have speed and we're trying to build trust. We routinely hear from sites, network sites that are very sophisticated, that have done 10, 50, a hundred studies with A CRO and says, we can build the infrastructure around this naive physician group or this naive research naive clinic. It's the same coordinators, the same people. We can help them. And yet they seem to think that, well, that AA haven't done a, research study before, so we're not gonna select them. I think we need to challenge that model more and more to say that we can build an infrastructure around research naive physicians and clinics so that we can make them successful in their communities. Embrace more some of these non-traditional concepts of having a single investigator for a network so that the network sites can participate as alternate locations rather than trying to make each individual site their own standalone site. So these are new models that site networks are embracing and are able to do that. Hopefully we'll get to see some success in those types of models.

Mohammad Millwala: 37:01

This is how Christine did it from what I remember. we ought to ask why are they doing this. we've voiced several years right, about naive investigators, David. But we make a panel and say, look, what do you guys think about naive? What is your hesitation? Maybe we can solve that hesitation. I think if there's a pain point for our, sponsors we should just ask them, Hey, what is your hesitation? And then if there's a hesitation, then That's our response to solve it. let's be definitive, let's define those problems or the pain points and let's attack those pain points, right? And if we can figure out the solution, then we've got a win-win situation.

Jimmy Bechtel: 37:35

Excellent points and I think that's a really great place for us to leave, the conversation today. Thank you Mohammed. Thank you David, for sharing your insights and your thoughts around some of these obviously tremendously complex issues. And, most importantly, not only your perspectives as trusted and longtime experts in this interview, but also. I hope that our audience is able to gain some solutions that they can bring back to their organizations, whether it be our industry level partners, but also our site level partners as well. And, maybe some things that they can think about as they approach the next calendar year until they get to come to the summit and talk about how successful they were with some of these concepts. So thank you both. Thank you everyone for tuning in and for listening. Again, Jimmy, the Chief Site Success Officer with SCRS signing off. Thank you for your attention and have a great rest of the week.