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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

A pragmatic approach to streamlining technology and innovating processes will help advance clinical data management.

Less is More in Clinical Data: The Road to Simpler and Better Trials

Improving access while maintaining a high level of research.

Advancing Patient Engagement in Community-Based Oncology Research

How today’s SSO reduces site burden and spearheads clinical system interoperability.

The Latest Advancements in Single Sign-On Technology

Survey from the Site Council gathered insights from its members on the quality of site coordinator work.

Understanding Study Coordinator Work Quality

This year’s conference highlighted a number of critical areas in clinical R&D including financial management, representation, and eCOA. 

Notable Discussions from SCOPE 2025: Aiming to Calculate, Accommodate, and Innovate for Enhanced Drug Development 

In this video interview, Krinx Kong, chief commercial officer, Cognivia, discusses how clinical operations professionals should be focusing on flexibility, behavioral visibility, and communication in the current landscape of managing vaccine trials.

Current Areas of Focus for Clinical Operations Professionals in Vaccine Trials

, Krinx Kong, chief commercial officer, Cognivia, discussed the potential impacts of policy shifts on vaccine trial design and patient perceptions. Stricter regulations could increase trial complexity, affecting recruitment and retention. Kong emphasized behavioral insights as crucial to understanding patient motivation and mitigating dropouts. Looking forward with the potential for policy changes in vaccine trials, clinical operations professionals must focus on flexibility, behavioral visibility, and effective communication to ensure success.

ACT: Looking forward with the potential for policy changes, what should clinical operations professionals involved in vaccine trials be keeping top of mind?

Clinical operations professionals are the backbone. They're the unsung heroes of successful trials, and they're also the first to feel the effects of regulatory change. If vaccine policy continues evolving, clinical ops leaders must focus on three key areas. First, flexibility. Build trial designs that can adapt to new data, new regs, or even public sentiment, that includes modular protocols and contingency plans for recruitment or site engagement. Second, behavioral visibility, it's not enough to track visits, check a box, or lab results. Ops teams must understand the psychological journey of participants, when they're likely to disengage, how they interpret study expectations, and what motivates them to stay. Third, communication. Clear, trust building messaging is essential, not just the participants, but also the site staff, to regulators, and the public. Clinical teams must be equipped with predictive tools to monitor adherence, risk, dropout likelihood, and placebo response all in real time. I know that's asking for a lot, but in summary, to my fellow ops family, be agile, be human centered, and be proactive. Vaccine trials are not just scientific, they're social, and the teams that understand both sides will be the ones who thrive in the next phase of clinical research.

Videos

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses numerous themes that clin ops can focus on to keep its trials running efficiently and effectively.  

Areas of Focus for Clinical Operations Leaders in the Current Research Climate

, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the impact of recent regulatory decisions on clinical research. Funding cuts by the NIH will affect intramural research and shared infrastructure. Additionally, the politicization of diversity initiatives will affect the enforcement of action plans. Lipset also highlighted the industry’s response to these actions and what it can expect moving forward.

ACT: From a clinical operations point of view, what does the industry need to focus on to ensure trials remain efficient and effective in light of some of the recent government actions affecting it?

One theme I would say is we do need to save our sites, but in the year 2025 our attention has to be on US academic research. We can't abandon them now. We have to be a little patient with them right now, so we shouldn't start reallocating our research portfolios away from academic sites and shifting studies, in earnest, more towards private, free-standing sites, which are great ways to mix a study, for sure, but our academic sites are going to face a resourcing challenge. Many of them have hiring freezes. They're having to reshuffle a lot of their own budgets right now. It's a challenging time for them, and not a time for industry to turn away. We need them to be sustainable, and we are going to have to be an important part of that sustainability, so be patient and stay by the side of America's academic research infrastructure.

Diversity and representation investments; hopefully we've learned enough and we can continue to share enough in this space that we can be efficient in realizing representation. It still will take extra effort in planning, but hopefully we can sustain our work there, because we could do it in smarter and more efficient ways.

Certainly for clin ops friends, the regulatory environment will remain somewhat unpredictable. There are regular changes happening on websites, on nights and on weekends, and we don't have email communications or newsletters coming out that are summarizing those yet. There is a certain level of unpredictability, and that unpredictability will continue with turnover and leadership. Will turnover in leadership with the inspection community in FDA bring consequences in terms of what inspection readiness looks like? We just we just don't know yet. I would say a last call for folks will be being mindful of possible changes to Medicare and Medicaid coverage, and realizing that that has consequences for research participation. When we do coverage determinations in our protocols, and we have decided that certain procedures in the site's study budget are not going to be paid for by the sponsor, but are expected to be covered by the patient's insurance, we may have more patients who are being exposed to cost sharing or who may have coverage gaps as a result of some policy changes this year, so this is a very important year for us to make sure that we understand ways that we as sponsors can help to cover these costs, so that we are not neglecting uninsured or underinsured patients and preventing them from being able to participate in trials simply because we've done a coverage determination where we thought an expensive CT scan, MRI, or routine care chemo was supposed to be covered. We need to make sure that these patients are being kept whole, and there are some very smart and innovative folks out there that have been figuring out ways to do so.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), highlights how recent funding cuts are impacting critical research resources.

Resource Reallocation in Clinical Research

ACT: How are the recent regulatory decisions impacted by the federal government impacting the clinical research industry?

 I think when we think about how these decisions are impacting the clinical research industry today, I think we already see a number of companies that are reallocating resources away from vaccine and vaccine drug development. Some are reporting delays and review times with staffing implications at FDA. We're seeing that FDA leadership in domestic as well as international collaborations, is becoming absent because those leaders aren't able to go and participate, so some of those initiatives will have leadership voids filled by representatives from Europe, Japan, and China, bringing their perspectives to leadership and setting those future strategies. I think, though, there is this consequence for us around which of our research sites need saving, right? We see a lot of rhetoric on social media of saving sites, but very often, the sites that are most prominent in those conversations are private, standalone sites, I would argue, in 2025 the sites that need saving will be the academic research sites who are struggling the most as a consequence of some of the policies.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, talks traditional research methods in clinical trials and why industry leaders remain reliant on them.

Reliance on Traditional Research Methods

, Rachael Higgins, chief commercial officer, PicnicHealth, discussed the company’s recently released 

2025 Annual State of Observational Research Report

. She highlighted some of the key findings including the persistence of more traditional research methods as well as how patient retention and incomplete data are creating challenges for the industry.

ACT: Why do you think so many industry leaders are still reliant on more traditional research methods?

I think about this all the time. I think this is probably the number one thing that people in my space think about. I think it's just comfort. I think people are comfortable with what they know, right? While the industry has mounting pressures to do things differently, and they know this, it's kind of like the devil you know, right? Even though they find they're spending way more money than they need to, things are taking way too long, they're not retaining patients, they’re certainly not getting the data that they need, they're like, “Well, we know this. It's tried and true, so we're more comfortable doing that.” That being said, as we mentioned those stats before, 78% of the folks that we actually interviewed are definitely open to doing things in other ways. I think it's just going to have to be continually talking to them, educating them, explaining to them that while it is different, different doesn't necessarily mean scary, and it could certainly be advantageous for them in the end.

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, discusses how EDC and EHR data can be streamlined to increase efficiency at sites. 

2025 Trends: Streamlining Data at the Site Level

, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends in protocol development for clinical trials. She also highlighted technological advancements, such as data interoperability standards like ICH M11 and CDISC, and how they are expected to streamline protocol development and support generative AI in 2025.

ACT: What do you think should be top of mind for clinical operations executives going in 2025?

I also think we're seeing a lot with real-world evidence and real-world data. Overall, there's an opportunity for streamlining again, at the site. Eighty percent of the data that we collect in the EDC is also collected in the EHR, and we're seeing a lot of solutions from a tech perspective out there, where you actually can leverage the data that's being input into the EHR, leverage that into the EDC, and then there's only about 20% of the data that's very specific to clinical research that then has to be filled out. That's a huge benefit to the site, because we talk a lot about burden for the site, and removing that burden, making life easier for them, not asking them to dual data enter the same information is really a huge benefit.

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), highlights how DTRA is working with sites and sponsors to gauge the feasibility of site-validated technology use.

Using Site-Validated Technology 

, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized clinical trials (DCTs) including misconceptions and the rapid adoption of DCT elements. Myles also highlighted DTRA's initiatives on site adoption, operational planning, and the integration of digital health technologies.

ACT: What are some initiatives DTRA is currently working on? What excites you the most?

Then the third initiative on site adoption has been fascinating. The work will continue in 2025 and it has been focused on what would it take for sites to be able to use the technology they've already validated and qualified at their network or location, instead of using sponsor-defined technology for the same solution. I'm not talking about a CTMS for patient scheduling, or all of the regulatory documents. I am talking about things like eConsent. We might think in longer terms about eSource, but when I hear from sites that they have used their own version of eConsent for 800 or more studies, it is hard for me to understand why they would be asked to accept an external eConsent platform by the sponsor. Now, the sponsor wants to ensure the data congruity and integrity is there, and that's really what we're trying to define; what would sites need to be able to show to sponsors to help the sponsors feel that the risk of having multiple solutions has been mitigated? It's really brain bending, because it's truly flipping the whole decision-making framework upside down. That's what we've been working on. We're going to continue some of that work in 2025 including trying to set out what are the questions you would ask sites if you were trying to get their input on the operational plan, and when, also, is there a way to collect high-level insights on the experience from site on using these technologies, perhaps by therapeutic area or region? I don't know the answer to that question. We're just scoping that work, and then we're going to dive in a little different direction into the world of how would HCPs be integrated into clinical research without making them investigators, aligned again, to those guidance documents coming from FDA, both for DCT and for what I call point-of-care trials. First, what do they think about that? Has anyone asked them, “Is this even a viable possibility, given the metrics and the constraints of the healthcare system and how it works?” Then, if it's a yes, what do they need in order for this to work?

In this video interview, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discusses several initiatives DTRA is working on to keep sites in-the-know on DCT elements included in study protocols. 

Keeping Clinical Trial Sites Informed 

We have a lot of things happening, so we're just completing some work from 2024 on three big topics around site adoption and a fourth around digital health technologies (DHTs) and the concerns about using DHTs from site and sponsor perspectives. I'll start with the site adoption. We've had three initiatives this year. Some will continue, by the way. One was really trying to understand how we might ask sites for their input around the use of DCTs (decentralized clinical trials) as the protocol was developed, that's evolved a little bit, and now we're thinking more, how do you ask for input around the operational planning of the study, as opposed to the scientific endpoints? That work will continue this coming year, in 2025 and what's really exciting to me about that work is that it's really a set of collaborations across primarily TransCelerate and DTRA, but with connections to SCRS and ACRP. The reason I call that out is because we're expanding the ecosystem, so you really do get that perspective from all the different stakeholders.

The second initiative, and this is the last meeting I was in, actually. We just wrapped up the work to try to codify what do sites need to understand when they're being asked to use these methods in trials, and it is not in the form of training. We actually worked with a cross -stakeholder team and came up with the question set that needs to be asked both at feasibility to the sponsors and at the investigator meeting or site initiation meeting by the sites with clarity on not only what's going to happen, but who's actually going to do the work. I'll give you an example, and it's interesting that this is not clear, but a lot of times, some of that tech friction that you mentioned earlier is related to the fact that the site becomes, or feels they become the tech support desk, and because that's a little bit in the weeds, it doesn't always get clarified anywhere in the study operations documents. The question set that we put together, which is across nine capabilities is: what do you need to know? When do you need to know it? Who needs to take action on it? This is so that the sites can feel like they're better informed in what they are agreeing to use, and more clear on the expectations of their roles in actually using these methods.

One of the big surprises for me this year was that when we did interviews with sites from across the world, different sorts of sites, academic sites, standalone sites, sites built for virtual visits, and meta sites, a lot of them reported that they actually didn't find out that DCT methods were being used until the investigator meeting or the site initiation meeting. That is probably in part related to the fact that until the final guidance came out this September, it wasn't clearly stated that those DCT elements needed to be included in the protocol. I was guilty of this myself when I did this back in big pharma, I would offer those methods, but not codify them in the protocol, so if you were not asking the questions that we put in that initiative work stream, it might be clear to the sponsor and not yet clear to the site.

In this video interview, Mark Melton, vice president of biospecimen data and operations, Slope, talks challenges at the site-level with collection.

Ensuring Proper Standards for Biospecimen Collection and Sample Tracking

, Mark Melton, vice president of biospecimen data and operations, Slope, discussed navigating data challenges in clinical trials, emphasizing the need for understanding complex data sources and ensuring a proper chain of custody for samples. Melton highlighted the importance of data mapping to standardize reporting across different labs and the necessity of secure data transfer to protect patient privacy.

A transcript of Melton’s conversation with ACT can be found below.

ACT: What are some of the operational challenges with biospecimen collection and sample tracking? How can they be addressed?

 I think the biggest part is, again, understanding the multiple stakeholders. For me, I always try to go back to 30,000 feet of if I was someone in a clinical trial, I want to understand, hey, I'm coming in, I'm giving my blood or my tissue or whatever it may be, depending on the therapeutic area. I think there's often an assumption when we all go to the physician, but particularly in clinical trials, I don't think it's really well understood by the public how those are handled. The biggest part is everyone understanding that, hey, we have a location, clinical sites that collect those and again, they send them out. How do we ensure that it's interconnected, regardless of the fact that we have multiple different companies facilitating one process, so you can imagine, even in one company, it's difficult to align on process and ensuring that we're hitting that.

The biggest thing is understanding what happens at sites. If we were to break this down, there's only a certain number of facilities that will test samples, while there may be a few hundred, it’s nothing in comparison to the sites, which are in the thousands, tens of thousands even globally. All of those sites are networks, sometimes they're independent entities, but understanding what their process is. They're the point of origin, so how can we ensure that they're collecting those properly? That starts with down to the inventory, so we send out all this inventory. If you can imagine, if you're a large cancer site, for example, I'm running 600 trials. I'm just making up a number, but I'm running hundreds of trials, and all of those trials are sending me, essentially material to collect those samples. How do we manage that material and then turn that material into blood or tissue or whatever sample type, and get it out? Then how do we track that through the life cycle? What we've done is kind of crazy. The science has gotten so specific, so the concept of precision-based medicine, meaning we're going to target a specific gene or protein, the science has gotten very specific and has advanced tremendously. It's outgrown the logistics of a trial which is kind of crazy to think about, that the science, and in my opinion, the hardest part, has somehow gotten to the point where we're getting very specific in what we're targeting. Yet the process of just tracking a sample from one location to the four or five other it touches is extremely difficult. It's interesting at the end of the day, if you look, regulators are coming in and now stepping in on how you test those samples, but the gap we have right now is they're not stepping in on how those samples are tracked and reported on. I think that that's the biggest thing we have to focus on, collectively as an industry, is, how do we step in and ensure proper standards to ensure a proper chain of custody?

In this video interview, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, highlights how stakeholders can best support sites throughout complex studies.

Supporting Sites from a Lab Perspective

, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed the benefits of central and local labs for clinical trials. Central labs offer harmonized test menus, standardized data collection, and global reach, ensuring consistent results across labs. Local labs, often co-located with investigator sites, provide quick turnaround times crucial for urgent patient care. In a world of complex clinical trials, stakeholders should support sites by focusing on planning, training, and incorporating feedback to streamline processes and reduce manual work.

A transcript of Aufderheide’s conversation with ACT can be found below.

ACT: Given the complexity of today’s trials and site staff being overloaded, what can trial sponsors and CRO partners do to ensure sites are supported in their work?

 I think the two key perspectives or pieces for me are planning and training. If we are planning for incorporating the voice of the customer, which in this case is the site, I know as a central lab, we do collect the site voice of customer a lot to ensure that, with all of the technologies that they're using and all of the various aspects of a clinical trial, that we're doing everything we can to make their life as easy as possible, and then just ensuring that the trial design and the way that we are designing all of the supplies that the sites are using, is as easy and straightforward as possible for them. The complexity of clinical trials doesn't really lend itself to that in some cases, so we have to get creative, but making sure that in the cases where it is a little bit more complex that where we are doing that training, and providing all of the documentation upfront that the sites need to know what is expected of them in collecting those samples and treating their patients.

In this video interview, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discusses the differences between working with local labs and central labs.

How Sites Work with Different Types of Labs

ACT: As it is important to take in the site perspective on their work with central labs or local labs, is there a noticeable difference in how they work with each?

 Yes, absolutely. There are complexities from a site perspective, and working with central labs, we're not the only central lab out there, and I think it would be safe to say that every central lab does things a little bit differently. If you have investigator sites that are working with multiple central labs, they are having to know from each lab perspective what is expected of them. The kits may be designed a little bit different, the way that they manage their supplies and manage their data and everything might be done a little bit different from each of the central labs’ perspectives, so that adds complexity to the site model.

Another aspect is a lot of times we see that the investigator sites have a preference for local labs because they are familiar with them. They know they're going to get their results quicker than sending it to a central lab. One of the key features of a site perspective is if they're using a local lab, a lot of times that data still has to get into the central lab database or the sponsor’s data set. How does that happen? That may be a manual data entry by the site. It may require some kind of data uptake by the central lab or even by the CRO or the sponsor, so it adds a little bit of complexity to managing the data on the back end, and then it also will tend to add some manual work on the site's side.

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