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Liz Beatty, co-founder and chief strategy officer, Inato, discusses:

The role of technology in improving site/sponsor relationships

How increased operational costs are impacting the industry

Podcasts

In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more. 

Improving Relationships and Diversifying the Site Selection Process

AI as an accelerator for data-centric, process-centric, and human-centric clinical research.

Rewiring Clinical Research: AI-Augmented Data, Processes, and People

Navigating a complex drug development landscape, sponsors must rethink their approach to risk in study design and execution.

Clinical Trials as a Competitive Edge: Strategic Considerations 

As stakeholders debate fair market value in clinical trial budgeting, a new task force works to align sponsors, CROs, and sites on transparency, sustainability, and efficiency.

Exploring Perspectives of Fair Market Value in Clinical Trial Budgeting

A blend of FSO and FSP models in the landscape of artificial intelligence can ensure CROs stay up to date with the unique demands of industry. 

Future Proofing Your Outsourcing Strategy: How to Stay Agile in a Fast-Moving Clinical Trial Ecosystem

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

Clinical Trial Monitoring: Should Randomization Be Included?

In this video interview, Kyle McAllister, co-founder, CEO, Trially, shares real-world examples of AI transforming clinical trial recruitment.

AI Levels the Playing Field in Trial Recruitment

, Kyle McAllister, co-founder, CEO, Trially, discussed the impact of funding cuts on underrepresented populations in medical research, emphasizing the importance of diversity-focused research. He highlighted the challenges created by budget cuts, particularly in patient recruitment and retention, due to reduced support staff. McAllister noted that artificial intelligence (AI) and new technologies like telemedicine are crucial for addressing these challenges by automating tasks and improving efficiency. He provided examples of AI's success in reducing chart review time and increasing patient enrollment in studies.

ACT: Are there examples you've seen where AI or digital tools have already made an impact on trial recruitment efficiency or targeting?

Absolutely, we're watching it every day. Like I said, the patient screening capability that we're rolling out to sites, we've seen sites decrease their chart review time by 90%. We also stack rank patients, so we can say, “Hey, these are the patients that fit,” and stack rank them based on their fit. That alone cuts 60-70% of the screen fail rate, because we're not spending time talking to patients that won't be a good fit for the study. Those are two really quick hit outcomes we've seen.

One really interesting, specific example that I love talking about, because I think it's just such a perfect example of how AI can be helpful in this space, is we have a, I would say, mid-size cardiology clinic that we work with. They have this really complex heart failure study that they've been recruiting for years. They've been on the study for—before we got connected—a year and a half, they had one patient recruited. The study was really struggling. The sponsor is breathing down their necks trying to get more patients into the study. After we got connected, it's been four months, they've now got seven enrollees in the trial, and now the sponsor is coming back like, “How did you do this? How could you possibly make this happen?” The really cool part, the part that gets me really excited, having spent time in the site world myself, is that was one research coordinator at one mid-sized site, and the second-best recruiting site on the study after her, is a giant academic institution with 20 CRCs coming through a huge database of people. It just really shows the power of really leveraging these tools can up-level a single individual to cover a lot of ground. Back to all the talk we've had about resourcing, it does take some lift off and make it so one person can achieve more. That’s just a handful of examples we've seen on the ground.

Videos

In this video interview, Daniel McAllister, Kyle McAllister, co-founder, CEO, Trially, discusses how clinical trial sites and sponsors are responding to funding constraints by turning to telemedicine, cost-containment strategies, and increased reliance on industry-sponsored research.

How Sites and Sponsors Are Adapting to Clinical Trial Budget Cuts

ACT: How are clinical trial sites and sponsors adapting to these constraints?

Ultimately, they're doing more with less, like I said before, they're resource constrained, and they're doing more with less, which looks like a lot of things, but it's leveraging new technologies like telemedicine or other tools that could decrease the cost of the actual care being provided, so cost containment measures, using remote monitoring tools, using teams that didn't previously work together across multiple types of studies or departments. We've seen sites turning more towards industry sponsored trials to drive more revenue and ultimately cover some of the research they're doing that was NIH and other government funded research, essentially using pharma money to keep the lights on and keep things moving forward. Not all that's terrible, like the idea of moving towards more efficiency and finding ways to drive more revenue to keep things more sustainable, there's some positive things in that, but I think the one of the big potential conflicts is it creates is a lot of the shift towards more industry sponsored research means the institutional priorities being shifted away from public interest focused research. Like I said, there's some pro in that, but there's also some real conflict and concern.

I think the brutal reality for a lot of sites is they're being forced to adapt in ways that aren't great, like they're having to cut staff, they're having to close departments, they're having to close research programs. I think there is a lot of, I'll say, research capacity that disappears with that, that it's going to take time to grow back. There's just research capacity that can't be covered, and we're in an age where it's easier and easier to find new molecules, find new things to do research on, and this infrastructure that was there to actually run that research is being whittled back. Sites are doing heroic work out there, but I worry that heroism isn't a sustainable staffing model.

In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how clinical trial sites and sponsors are responding to funding constraints by turning to telemedicine, cost-containment strategies, and increased reliance on industry-sponsored research.

In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, explores how CRO partnerships are shifting to deliver greater efficiency, cost-effectiveness, and regulatory insight in response to tightening budgets and an increasingly complex clinical research environment.

How CRO Partnerships Are Evolving to Meet Changing Industry Demands

In a recent video interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech discussed the company’s recent accomplishment of winning the Citeline CRO Partnership of the Year Award in recognition of its partnership with Tune Therapeutics. Ng-Cashin highlighted the importance of seamless, trusting relationships in clinical research, as well as the roles of cost efficiency, risk-based approaches, and leveraging CRO expertise to navigate partnerships in the evolving regulatory landscape.

ACT: Considering the evolving landscape of clinical research, how do you envision the role of CRO partnerships changing in the next few years?

I think we're already starting to see that. Depending on the type of sponsor and the type of CRO I'll start with what I'm living at the moment with being a mid-sized CRO servicing biotech. Funding is tight. People are looking for cost efficiencies. People are looking to their CRO partner to not just drive cost for our own enrichment, but to really get in the trenches and understand where—for instance, looking at a risk based approach—where can we spend a little less so that we can save our resources for the things that we think are going to be most complex, the endpoints we think are going to be the most valuable, whether it's to the regulators or whether it's to the investors for the next raise, etc. I think partnership around how to best deploy capital against these studies will be important.

For a different sort of situation where it's a bigger CRO and a bigger sponsor, I think pooling the resources. A lot of times, in my experience, there's duplication of function in the sponsor and the CRO when you're talking about larger organizations. I think coming to the table, being honest about who is going to do what. If you're on the sponsor side, how much double checking or oversight is appropriate? Not to say that we don't need oversight across partnerships like these, they're complex. However, don't confuse partnership with duplication and redundancy. I think that drives efficiency, not only in cost, but also in speed. I think that's really where people are focused, as well as where we've always been, data integrity. It's an evolving regulatory landscape. You're trying to understand what's acceptable now with this, that, or the other health authority, you're trying to anticipate what you think is going to be okay as health authorities evolve. I wish that weren't political, but it is, so trying to see ahead, I think where sponsors can leverage their CRO partners is, as a sponsor, maybe you're doing one Phase III trial in a particular indication per year to five years, your CRO partner might be doing three right now. What are the insights they're seeing about how the regulators are reacting to those designs, those data, etc. I think just the acknowledgement that the different sizes know different things, and we should bring all that knowledge to bear as we go forward in uncertain times.

Vendor Strategy & Collaboration

In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, emphasizes the importance of proactive communication, strategic alignment, and cross-functional collaboration in establishing strong, effective partnerships between CROs and pharmaceutical companies.

How CROs Can Build Trust and Alignment with Pharma Partners

ACT: What are some best practices that CROs should focus on for creating strong partnerships with pharma?

I think that what we can do on the CRO side is not make assumptions and ask. We might think that the study priority, the corporate strategy, strategic priority is one thing, but if we're wrong, then that sets us off on the wrong foot. I think on the sponsor side, sometimes we think the CRO knows something they don't know. Then we’re upset, surprised that something was missed or something didn't go well. It sounds very trite to say it's about communication, but it is about communication, and really pushing—from the CRO perspective—your sponsor colleagues. What's important? What are you concerned about? What are the top three risks you see coming up in this next phase of the study? How can we engage to look at that proactively and put a plan in place. It's about planning. It's about anticipating. But on the CRO side, we can't know what we don't know. We can't anticipate all the time what we need to know, so that's really where driving those conversations, driving the communication, and it's my experience on the CRO side, that the more you ask, the more you understand not just the tactics and the operations of what's going on, but what's the strategy, what are the priorities. Then you're driving that partnership relationship, and I think it needs to be done at all functions. I happen to be a physician, and I'm the chief medical officer here at Novotech, and I feel very strongly that that physician-to-physician communication, bond, relationship is critical to the success of a study, because “birds of a feather flock together,” driving those functional partnerships, I think is another way to drive those partnerships.

In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, shares insights on how sponsors and CROs can cultivate a “one team” mindset by setting the right leadership tone, encouraging collaboration, and leveraging team-building strategies to drive clinical trial success.

Fostering a Unified Team Culture in Sponsor and CRO Partnerships

ACT: How can sponsors and CROs establish a "one team" mindset to drive clinical trial success?

I've been on both sides of the fence on that. I can speak to an example where I was at a biotech and I had multiple vendors and a very small internal team. Like I said, I think the leader of that team sets the tone right. We're not “things go wrong.” We're not going to be pointing fingers at, “It was this company's fault or that company's fault.” There's going to be collaboration in the good times and the bad times. I think setting that tone early on from top to bottom, as I mentioned. I also think there are ways to incentivize that behavior, whether it's team building up front, we're all in a cost constrained environment at the moment, but if you could make an investment in bringing the team together, we're doing all this virtually all the time, but if we could bring some people face to face, get some emotion, get some personality behind those relationships, I think that helps. I think there are incentives that you can make common. If the team achieves, set your metric, first patient in or 50% enrolled, whatever the leadership decides, together, there's some kind of shared reward. I think these are some things you can do to keep it positive, keep it collaborative.

In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, shares why clear communication, strong leadership, and cultural alignment are essential to building effective partnerships between CROs, sponsors, and other stakeholders in clinical research.

Bridging Communication Gaps to Strengthen CRO-Sponsor Collaboration

ACT: In your view, what challenges do stakeholders most commonly encounter when trying to form strong partnerships, whether it’s with sponsors, pharma, etc.? How can these be solved?

I think, especially in our current funding, our current regulatory environment, there's a lot of pressure to deliver data, to deliver a successful program. During those tight times, I think that's when some of these things that we just talked about, in terms of collaborative partnerships, being proactive, set the setting those things up a priori. That's when these things break down. My observation is a lot of times at the top, at the executive level, there's an agreement, there's collaboration, there's a holding of hands and a singing of kumbaya about how we're going to work together and be one team. What's the cliche? It doesn't matter what it says on your badge. We're all one team. I think, how that gets communicated, and how the team that are actually operationalizing the project on both sides, how that trickles down and gets interpreted and gets lived within the conduct of a study, that, to me, is a communication thing and a leadership thing. It behooves those of us who are at the executive level to make sure we're modeling the right behavior, to make sure we're putting in the right metrics and expectations about behavior, because a lot of this stuff is soft skill, right? It's like how you show up. Are you assuming positive intent from your counterparts in the other company? I can't emphasize enough, you can write all this stuff down in a playbook and in a process, but if you get on a video call and the expressions are like this. It's not going to work, right? That's not how the words are lived and I think that matters, and I think just spending some time on that in the kickoff and really showing that you have executive support to make this partnership work, I think goes a long way.

In this video interview, Judith Ng-Cashin, MD, chief operating officer, Novotech, explains why seamless collaboration between CROs and sponsors is critical to advancing clinical trials, and reflects on Novotech’s recognition as Citeline CRO Partnership of the Year.

Building Strong CRO-Sponsor Partnerships to Improve Clinical Trial Success

ACT: Novotech was recently awarded the Citeline CRO Partnership of the Year Award in recognition of its collaboration with Tune Therapeutics. Could you discuss the importance of this award to the clinical research industry? What does it mean to Novotech to win it this year?

I think the more that sponsors and their CROs can really develop a seamless, trusting, collaborative relationship as they go into a clinical development program, a study, whatever it is, the better off everyone is—the sponsor, the CRO, the investigator, but most importantly, the patient, because then the patient is well taken care of. I think what's challenging about that is everybody's coming at the execution of a particular study with a different perspective, with slightly different objectives, so the more that you can get aligned proactively before the beginning of a study, and really set common goals that everyone understands. I think you're setting yourself up for success. Of course, we're dealing with humans, we're dealing with science, we're dealing with biology, so there's always going to be something that's unexpected, something that throws a wrench in the process, but if you build that foundation, I think you're making it easier for yourself, and setting yourself up for success.

Why is it important for the industry? I've been in the industry both on the sponsor side and on the CRO side for over 20 years at this point. The whole ecosystem on how we get clinical trials done has evolved from when I started in big pharma, everything is in house to where I am with Novotech, where we largely service the biotech sector, so that might be five people in an office, and they really are counting on us to be their partners and extension of themselves. The more examples we have of how to do this successfully, the more everyone benefits, because it's very heterogeneous, and how people execute on this, so if we can point to success stories collectively, I think we all do better. Like I said in the beginning, for both ourselves, but also the patients that we serve.

What does this mean for Novotech? Listen, we are thrilled. It is our business model. It is our ethos that we should be a strategic partner, not just as we used to think of it, “I'm the head, you're the arms and legs.” That I think, is not a winning strategy for any kind of company on either side, so for us to really have external recognition that what we did with Tune was a step in the right direction in terms of partnership, and being an example of that, and being recognized for that, it just means the world to the company, so we're really, really proud of that.

In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, explains why seamless collaboration between CROs and sponsors is critical to advancing clinical trials, and reflects on Novotech’s recognition as Citeline CRO Partnership of the Year.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses how key stakeholders in clinical research are responding to uncertainty with budget cuts and administrative shifts.  

Redefining Collaboration in Clinical Trials: How Sponsors, CROs, and Sites Can Align

, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discussed the Trump Administration's ‘Most Favored Nation’ pricing policy for pharmaceuticals, which aims to match the lowest global prices to reduce costs in the US. Based on his past experience at Eli Lilly, Kremidas expressed concerns about the policy’s impact on pharma companies' clinical development and NIH funding, which could lead to reduced investment in new therapies. Kremidas also highlighted the potential of multisite clinical research corporations (MCRCs) and how they can streamline clinical operations by consolidating contracts and improving efficiency.

ACT: Looking forward in this landscape of uncertainty with budget cuts and administrative shifts, how can key stakeholders in clinical research better collaborate to support both innovation and affordability?

I think first and foremost, one of the most important things is communication and transparency. If you think about MCRCs or just sites in general, they're sort of at the end of the line, if you will, so you have the sponsor developing the protocol. In many, many cases, the CRO executing that protocol from a management perspective, and then, of course, the sites executing the protocol in terms of dealing with the patients and collecting the data. Often, again, in the past, what has happened is the protocol gets developed, it’s thrown over the fence to the CRO, the CRO then throws it over the fence to the sites, and there's not an ongoing communication during the development and execution of that protocol. That's not to say there aren't examples where it happens. I don't want to imply that, but I think there are plenty of opportunities to be more engaged from the beginning of the design of the protocol, both with the CRO and with the sites, as well as through the execution of how that then gets put into place from an operational perspective, so that's one area.

Along with that—still with transparency, communication—as things are ongoing, getting information back from sites about what are the experiences with collecting the data and engaging the patients, etc. The other thing I think that is important is the whole idea of training. If you look again at the traditional site training model, each site is trained differently, and it might be by different CRA, so you're going to get inconsistency. One of the things I learned when I was deeply involved with Six Sigma is the more variance you have, the higher the probability that you're going to have errors or inconsistencies, so the idea is, the more you can be consistent, and the fewer people involved in doing the training, and the more standardized the training is, the better quality you're going to get from an execution standpoint, so that's an area.

Finally, there's a whole idea of shared risk models. I think over time, we're going to see the MCRCs partnering with pharma companies and with CROs. In fact, with CROs, as you're probably aware, some CROs already own their own MCRCs, so they're seeing the vertical integration as an opportunity. We see it the same way. We think that the vertical integration of the sponsor, to the CRO, to the sites, or from the sponsor directly to the sites, is a huge opportunity. There may be ways to share the risk of the development of a particular product or the execution of a particular protocol.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses how key stakeholders in clinical research are responding to uncertainty with budget cuts and administrative shifts.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses the need for more data and education on multisite clinical research corporations before adoption can become more widespread. 

Educating the Industry: Unlocking the Full Potential of MCRCs in Clinical Development

ACT: How are sponsors and CROs responding to this shifting landscape? Are they actively seeking out MCRCs, or is more education still needed?

In general, there's more education needed on the concept. There are a handful of sponsors and CROs that indeed, yes, they're going to the MCRCs, but generally speaking, this is a slow to change industry that we are in here. What I described earlier about going to the MCRCs first is not the standard approach, so therefore we definitely need more education and more data showing the value that MCRCs can bring to the industry and to bringing products to market faster.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), highlights opportunities to improve upon inefficiencies that currently exist in clinical workflows. 

Rethinking Clinical Trial Efficiency Amidst Cost Pressures on Pharma

ACT: We’re seeing increased financial pressure on pharmaceutical sponsors. Where do you think they'll look first to find cost efficiencies, and how do clinical trials fit into that equation?

There's two major areas, if you will, that a pharma company can look at. One would be in their sales and marketing or the commercialization of the products that they currently have available. I'm sure there are ways to cut costs there. I'm not going to go into that, because I think this audience is really more interested on the research and development side of the equation. As I mentioned earlier, it's going to have an impact in terms of the approach that pharma companies take to developing new drugs. Again, the area of the research side, so pre-clinical there's probably opportunities there to cut costs. I don't know if that's good or bad, probably bad, but on the clinical development side, we think that there are opportunities to reduce the costs of development. Now, a lot of effort these days is going into using new technologies in order to do that, for example, artificial intelligence and some of these other tools. One of the things that that we feel is important is to understand that the development of these of products, as you get through Phase I, II, and III for submission, technology helps, but at the end of the day, it's people who administer these studies. There are people that manage the studies, the site staff, the pharma company staff, the CRO staff, so there's going to be an awful lot—we believe—of opportunity to improve on the inefficiencies that currently exist from the way things are currently structured, in the way that we develop drugs, Phase I-III at this point in time.

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