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DE&I

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1rem

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

As clinical trials become more complex, success depends on early collaboration, thoughtful protocol design, and practical strategies to manage risk, reduce delays, and support patients.

Navigating Complexity: Strategies to Accelerate Modern Clinical Trials

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors

A new global report finds that clinical research teams are making progress but still lack the skills and tools needed to keep pace with growing trial complexity and emerging technologies.

 Empowering the Workforce of the Future: The Trends and Training That Will Drive the Future of Drug Development

Outdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with modern, compliant marketing tools could turn the tide.

Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment 

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

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

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, shares key strategies for maintaining operational alignment and compliance in decentralized trials including unified data platforms, aligned SOPs, and clear governance and escalation pathways between sponsors and supply chain partners.

Best Practices for Operational Alignment in Decentralized Trials

, Luke Wilson, senior director, biotech, pharma services, Thermo Fisher Scientific, discussed the role of data visibility in clinical trials, emphasizing the need for actionable data to meet aggressive timelines and budgets. Remote monitoring is crucial for quick decision-making and patient safety, reducing site burdens and leveraging advanced technology. Integrated systems help study sponsors meet evolving regulatory expectations by removing data silos and streamlining inspection processes. Barriers to real-time trial oversight include data silos and the need for integrated systems. Best practices for decentralized trials include unified data management, clear SOPs, and governance pathways to ensure operational alignment and regulatory compliance.

ACT: As trials become more decentralized and data sources multiply, what best practices can ensure operational alignment and regulatory compliance throughout the trial lifecycle?

Yeah, so I think again, unified data management platforms, that's probably number one, establishing clear SOPs and training, again, between sponsor and supply chain companies, making sure that the teams are highly aligned. Another thing that may seem tactical, but it's super important, is creating clear governance and escalation pathways. I think, again, this is something that I really want to double click on, that as an important component of a collaboration between again, sponsor and supply chain partner.

Videos

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how integrated systems and data transparency enable sponsors to meet evolving regulatory expectations and streamline FDA inspections through enhanced operational readiness.

How Integrated Systems Help Biotechs Stay Inspection-Ready

ACT: What role do integrated systems play in helping sponsors stay inspection-ready and meet evolving regulatory expectations?

 You mentioned regulatory. I think the market is changing rapidly in front of us. If you think about how data is captured, how data is managed within certain regions and even therapeutic areas, it’s really important that we remove some of those silos to enable data to be captured and logged in an appropriate way that then can be provided to the sponsor. We actually had a recent example with a customer, they were a small biotech, and they were about to have an FDA inspection, and they commented on how some of our teams at Thermo Fisher Scientific captured the data, how we provided it to them. It really helped streamline the process of that FDA inspection, and resulted in a very successful inspection for them, which is critical. You imagine biotechs, they've got to have partners who can enable them to be inspection ready to your question, and it's really important that we support them on that journey with our expertise within Thermo Fisher Scientific.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how real-time data access is helping biotechs accelerate trial timelines, ensure patient safety, and gain greater oversight—especially through integrated CDMO and CRO partnerships.

Why Real-Time Data Visibility Is Essential for Biotech Clinical Trials

ACT: Why has data visibility become such a critical driver of efficiency and oversight in modern clinical trials, especially for biotechs?

I think for biotechs, typically what we're seeing now—and probably now, more than ever—is they have fantastic products that they've developed. They have very aggressive timelines, and they have budgets that they need to adhere to. The way that we think about data and how it enables biotech and enables the industry is, if you think about partnerships and multiple suppliers in the supply chain, the more data they can provide to the biotech, the more actionable data. It means that they can, live, make decisions that will help them accelerate their timelines, and conduct a successful clinical trial, but also keep the patient safe within the trial as well. At Thermo Fisher Scientific, the way we're addressing this is with our Accelerator Drug Development program, where we're combining CDMO and CRO services. That means you have consistency across the supply chain, and single data sources that we can provide to our biotech partners.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research organizations to assess their portfolios, diversify funding sources, and strengthen industry-academic partnerships to maintain compliance and continuity amid shifting federal priorities.

How Research Institutions Can Future-Proof Compliance Programs

, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders and federal funding policies. She highlighted the confusion and increased scrutiny on research projects, particularly those involving diverse populations. Practical risks include potential legal scrutiny and funding agency actions. Heffernan also emphasized the importance of accurate reporting and careful documentation to avoid false claims. Future-proofing compliance involves thorough portfolio assessments, diversifying funding sources, and strengthening partnerships between academia and industry to support early-stage research and innovation.

ACT: What is your top piece of advice for clinical research organizations that want to future-proof their compliance programs in an increasingly politicized funding environment?

I think the main advice that I would give people is, is a pretty obvious one, which is what people, I think, have been doing since January: do a thorough assessment of your research portfolio, look at the areas that your organization really wants to focus on. What are the areas that align most with your mission, your patient population, the potential for IP development and commercialization for your organization, the ultimate financial impact ways in which your organization can supplement funding for certain efforts and maybe not others. I think ultimately, diversification of funding sources is going to really be key for all parties involved going forward, and a point that I think is sometimes overlooked, but really important to note is that these cuts to federal funds are not only impacting the academic sector, so the pharmaceutical industry and a lot of the other industry players have been and continue to be in strong partnership with academic hospitals, medical centers, universities, with respect to that early-stage investment time, so the cuts to this early-stage funding that we're seeing are also going to have downstream impact on the ability of pharmaceutical companies to have access to important early-stage ideas that they can then evaluate and decide whether to license and how to possibly partner with respect to the commercialization. I think we're going to have to see a new commitment by both industry and academia to a renewed partnership around how we go from bench to bedside with these new early-stage concepts and innovations because that missing bridge funding that we get, normally, from the federal government to help determine what's worth bringing to market is something we're going to see, obviously, severely reduced. I think for our academic and institutional and other research clients, using your innovation offices, your clinical trial offices, for increased outreach to the private sector for these types of early-stage collaboration agreements and collaboration arrangements to try and supplement that bench science research funding, I think, is something that we're going to have to see our clients focusing on in the near future.

Vendor Strategy & Collaboration

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research teams to closely scrutinize federal fund certifications and document good-faith compliance efforts, even when policies stem from nonbinding executive orders.

Performing Risk Assessments Amid Shifting Federal Guidelines

ACT: How can research teams perform meaningful risk assessments to ensure feasibility before applying for or drawing down federal funds?

Like the reporting on past aims and progress reports on diversity aims, this has been another area where we've had clients really struggling, in part because everyone right now is obviously doing what they can to ensure that they remain eligible for as much of their federal funding as possible. The motivation is to make the certification in order to be able to draw down the funds. However, it is really important that organizations are looking at those certifications really carefully, that they are taking whatever reasonable, good faith effort steps they can to make sure that they are accurately representing that certification. We've seen a lot of different scopes of certification, so sometimes it's limited to the funds that are actually being drawn down in that no particular moment, and it relates to whether or not the funds themselves are being used to further aims that are not aligned with the government's priorities. That's an easier diligence thing, obviously, because you're looking at just whether or not that project itself has any elements that might cause concern with respect to the stated policies of the funding agency and the administration. I think the harder ones are the ones that ask you to represent what you've sort of done, everything you can to make sure that your entire program at the organization is in line with the executive orders, which again, begs the question, they're not laws. Essentially you're getting a backdoor certification to compliance with something that's not a binding law. I think that's deeply troubling to me as a lawyer in terms of a process for implementing that type of requirement, but what we've said as a practical measure for clients is do your best to make sure you're documenting all the efforts that your organization is taking across the board to evaluate its programs and to make sure that it is compliant with the law, and make sure that those efforts have been undertaken and fairly documented, so that you have something to stand on if it's challenged.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how clinical research teams can accurately report on diversity-related grant work while minimizing exposure to False Claims Act scrutiny, by focusing on precise language and framing.

Balancing DEI Reporting With Legal Risk

ACT: There’s growing concern around including DEI-related language in reporting. How can research teams acknowledge diversity-focused efforts without inadvertently increasing their exposure to legal scrutiny, such as False Claims Act risk?

This is a great question, and an area that I think we've seen some of the most concern expressed by clients. Many of our clients are in a really challenging position when they have to currently report on the completion of aims within a grant or within a trial project that were previously approved and designed at a time when there was both acceptance of and even really a mandate for diversity centered aspects of federally funded research. One thing that I think is important for organizations to remember, is that it's really fundamentally important for them to be accurate in how they report out the work that they've done. You can really put yourself in a False Claims bind by misrepresenting in any way the work that was done on a grant in a way that's inaccurate, that said, the way you frame that, the way you phrase it, the way in which organizations can accomplish that type of progress reporting on previously defined scopes that involved diversity efforts and mandates and avoid hot button trigger words. Those are the important considerations that we're helping clients to navigate.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, outlines how even unenforced executive orders can influence federal funding decisions, prompting sponsors and sites to alter public trial messaging to avoid informal scrutiny.

The Quiet Risks of Ignoring Executive Orders in Research

ACT: What are some practical risks that sites or sponsors might face if they fail to align with an executive order that hasn’t yet been codified into law?

Right and that is exactly the limbo that I was describing. I think what we're seeing is concern about just increased scrutiny on their projects by the funding agencies, increased scrutiny to the institution. For example, one thing I've seen a lot of clients grappling with is what trials are they publicizing on their websites? Many times, institutions, for good reason, will put forward the available clinical trial opportunities on a public facing website, so that the public is aware of opportunities to participate in research, and they really had to rethink, whether or not the names of these trials, which, again, were all approved and ongoing before the administration took office, and before any of these new policies were articulated, but whether or not putting that out to the public is really going to bring additional scrutiny to their organization that might even go beyond the scope of the name of the trial, and obviously what I'm referring to is trials that by their name, talk about involving or participation by underserved populations, ethnic minorities, or the LGBTQ+ communities, other things that the organization may be aware have become the target of certain executive orders. Again, these are ongoing trials that have IRB approval and that are actively enrolling. I think it's been a real it's been a real conundrum, I think, for organizations as to whether or not they remove reference to those types of trials on their website, simply by virtue of the executive orders.

Even going a little bit further when a restriction might not be overtly applicable yet, it might just be in the executive order, it hasn't yet been codified into law, or an agency has taken action that has been enjoined by the courts, which we've seen a lot of as well, we've nonetheless seen some not so subtle messaging from the funding agencies that's off the record to our clients, where, basically, even though the stated law right now is proceed as usual, we have had off the record messaging of, 'You really better revise this application for funding to remove all references to diversity, or you're not going to get considered.'

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, offers practical insights for sponsors and CROs exploring partnerships with retail research sites, emphasizing collaboration, innovation, and shared accountability.

Advice for CROs and Sponsors Partnering With Retail Trial Sites

, Ramita Tandon, chief biopharma officer, Walgreens, discussed the company’s three-year milestone of leading clinical trials. Tandon highlighted several of Walgreens’ initiatives in the space, including how its 8,000+ pharmacy locations are bringing research directly into communities. She emphasized the need for community-based partnerships, cultural competence, and education to empower patients. Looking forward, strategic partnerships will be key in enhancing inclusivity and accessibility, with the ultimate goal of bridging gaps in clinical research and public health.

ACT: Walgreens has partnered with over two dozen life sciences companies. What advice would you offer clinical operations leaders on structuring productive, patient-centric collaborations with new types of trial partners like retail clinics or mobile units?

We are trying to build the right highway and bringing trials closer to where the patients are, recognizing that the barriers exist and making sure that we're building an ecosystem to remove those barriers and make it easier for participation, and then also leveraging insights, whether, again, it's qualitative insights, quantitative insights, because you understand who the patient population is, and that will start to allow us to better engage patients and drive smarter, in recruitment, and redefine that patient experience.

From our perspective, what we're seeing, and I think what we're seeing in the industry, a shift towards community-based clinical research, and I think that represents a significant paradigm change in the overall clinical research ecosystem. I think historically, many potential participants have been hindered by geographic or logistical challenges, limiting the applicability of trial results, so for us, it is really around building that model that brings trials within the communities.

I think just hosting trials in retail settings. Where Walgreens pharmacies are located, our goal is to make sure we're reducing those barriers. We're facilitating more of those collisions, more of those interactions with patients, getting patients comfortable. It's really around educating and making patients aware that clinical trials is a key part of one's care journey. Those conversations are not happening at all the provider settings. We're doing our part from a pharmacy perspective, and we're hoping those conversations are happening more consistently across all provider ecosystems, and that's really to ensure that the outcomes of these trials when they are finished, are applicable to a broader segment of the population, and then ultimately, when a drug does get approved, it improves the utility and the impact of medical research. For us, the integration of retail pharmacies into clinical research really affords a very unique opportunity to bridge the gap between research and then real-world data collection. For example, pharmacy-based clinical trials brings research opportunities directly into communities, expanding access to capturing real-world data, things that are happening in real time. As a result, pharmacy-based community trials, we have the ability to reach participants who may never have considered enrolling in traditional clinical trial settings, and just broadening that scope and inclusivity in clinical research.

In this video interview, Heather Horville, solutions consultant at Greenphire, emphasizes the growing need for clinical operations to embed patient-centric services—from consent through final visit—to improve retention and overall trial success.

Designing Trials Around the Full Patient Journey

, Heather Horville, solutions consultant, Greenphire, discussed the challenges of retention and trial timelines due to increasing financial and logistical burdens on patients. Horville highlighted strategies to address these issues, such as early planning, patient advocacy, and site selection based on local needs. For complex trials, engagement through diary entries and stipends, and human interaction via concierge services will be critical. Future improvements will emphasize a comprehensive patient journey, incorporating services like travel prepayment to enhance trial success.

ACT: Looking ahead, how might clinical operations as a function evolve to better support the patient experience and, by extension, trial success?

I think that it's going to be more and more important to consider the entire patient journey from start to finish, really focusing on their experience and designing engagement throughout the life of the trial, from the initial consent and what that experience is, all the way through to the final visit and that final data collection. I think that's really going to be key. A lot of in line of what we've already been speaking about, but I think it's also important for the folks, the sponsors, really conducting these trials, to plan for these services to be in play, to engage patients, incorporating what used to be known as nice to have services like reimbursement, stipends, and travel, as really a way to ensure that we retain our patients throughout the trial. We know that we should be speaking to advocacy groups, reimbursing patients, and prepaying for travel. We know this, but all of these things cost money, and the data shows that they are more and more crucial in successive trials, so streamlining these services, ensuring that we're considering the site's experience, like we mentioned before, and planning to have these services involved can really help shape trial success in the future. I think it's just going to be more and more important to do so.

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.

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