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Articles

Compliance with state telemedicine requirements is imperative, as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.

Telemedicine Considerations When Conducting Decentralized Clinical Trials 

In this Q&A, Megan Bailey, EVP and president of central laboratories and international, Labcorp, discusses how central labs are evolving beyond testing to become strategic partners in clinical trial success.

How Central Labs Are Powering Decentralized and Hybrid Clinical Trials

Addressing data integrity and compliance concerns.

Collaborative Strategies for Technology Integration in Clinical Studies

Progress made in measuring decentralized clinical trial use in patient recruitment and retention.

Replacing Anecdotal With Empirical Evidence On Impact of DCTs

Research from the Tufts Center for the Study of Drug Development’s PACT Consortium shows DCTs encourage higher participation across multiple demographic groups.

New Data Links Decentralized Clinical Trial Approaches to Improved Diversity in Patient Populations

Use of decentralized approach in a Phase 1 pharmacokinetic trial shows the ability to enable remote data collection and monitoring, which could improve patient access and enhance the efficiency of clinical research.

Decentralized Phase I Trial Highlights Promise of Remote Data Collection to Improve Clinical Research

In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), explores how emerging technologies such as wearable devices, real-world data analysis, and decentralized trial designs can improve the identification and engagement of potential cancer clinical trial participants.

Leveraging Technology to Enhance Cancer Clinical Trial Recruitment

, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discussed the current state and challenges of cancer patient participation in clinical trials. Barriers to participation can include lack of understanding, economic burdens, and implicit biases. Robinson highlighted solutions such as increased education, legislation like the Clinical Trials Modernization Act, and engaging patients early in trial design. He also touched on the use of technology, such as biomarker testing and wearable devices, which can also enhance recruitment and reduce burdens.

ACT: In what ways can technology be utilized to identify and engage potential cancer trial participants more effectively?

This is actually a really exciting topic to me, because I think we are in an era where we can truly engage technology to help answer these kinds of questions. As I mentioned earlier, trials are becoming more and more complex because of the targeted therapies that we're testing in them, so using the kinds of modalities and technology that is available now for biomarker testing, real-world evidence, so large dataset analysis to really understand what patients have an opportunity to respond to these targeted therapies, etc. and you can sort of hone in on them, on those patients for trying to recruit them, is important. I think technology can also be used to address these economic and time burdens as well. When you think about smart watches, cell phone apps, wearable devices, a lot of the time and economic burden comes from patients having to travel back for extra scans, extra lab tests, those sorts of things. You can envision ways in which that technology can be used to supplement or take the place of those tests. Similarly, you can use in home testing to reduce travel time, to decentralize the trial designs. I think you could even take advantage of technology for developing better educational materials as well, so lots of opportunity, and I think it's an area of active research.

Videos

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, discusses the alliance’s latest step in evaluating the sustainability of digital versus traditional clinical trial approaches.

Sustainability in Clinical Trials: The Pistoia Alliance’s Initiative to Assess Carbon Footprint

, Theirry Escudier, Portfolio Lead, Pistoia Alliance, discussed the alliance’s newest initiative to assess the carbon footprint of clinical trials. The initiative aims to answer whether decentralized clinical trials positively or negatively impact carbon footprints. Escudier also discussed how clinical research stakeholders are slowly beginning to adopt more sustainability practices, focusing on reducing waste and costs.

ACT: Could you tell our audience a bit about the Pistoia Alliance’s newest initiative to assess the sustainability of different clinical trial models?

In fact, to be very clear, we have started with this already three years ago, to dig into the issue of how can we assess the carbon footprint of clinical trials? Our aim with this three years ago was to try to assess the impact of DCT (decentralized clinical trials), but it was so tough to be able to evaluate or propose a standard framework to be able to do that that in fact, with the partner company we have been working with called Sustainable Healthcare Coalition (SHC), we have decided, in fact, along the journey in the last three years, first to focus, can we build a proper tool and framework to assess the carbon footprint of any type of trial? Let's start to do that. To do that, we had to collect data from both company members, the one from the Pistoia Alliance and the one from the Sustainable Healthcare Coalition. We have been collecting, let's say, operational data from in a way, protocol start until clinical summary report finalization, and we have identified what we call an activity based model, that is to say, looking at the clinical trial flow chart and looking for preparation, implementation, regulatory, IRB, monitoring, data collection, and among those bricks we have went to lower bricks, and we have been able to ask our members, we want to collect your operational data, such as monitoring visits, your monitors are going to visit one site, by car, by train, by foot, or whatever, for the patient, the same type of story for the investigator also at the site, we have tried to collect those data, not easy, because most of the people have never done that before, but so at least, we have been able to put in place the standard framework that is now available. In the next step of the journey, we are going really to come back to the early days of our question: do DCTs have a good or bad impact on the carbon footprint of clinical trials? We will be able to answer, hopefully in one year time, when we will have collected a lot of data, hopefully from our members.

Addressing Clinical Trial Challenges

ACT: What advancements do you foresee for Medable AI and Medable Studio, and how might these innovations change the way clinical trials are conducted in the coming years?

We designed Medable Studio to scale clinical trial approaches across an entire company, enterprise, portfolio of work, and development asset. That’s one of the key ways we see growth happening. Up until now, we’ve conducted many pilot studies—companies would run a single study to test the approach. We’ve done a lot of those, and we’re now seeing the value they bring. We understand that operating trials this way offers significant benefits but scaling it across multiple trials has been a challenge. However, we’re now seeing companies adopt this approach more broadly.

This isn’t something limited to one or two trials or reserved for Phase IV studies—it’s a model that can be applied across all trials. It enables us to scale in ways that weren’t possible before. Traditionally, scaling innovation required significant human resources, almost like a tax or capital investment. Medable Studio eliminates that burden, making innovation more efficient.

AI further enhances these capabilities. We’ve already integrated AI into some of our tools. For example, building eCOA instruments—a process that once took weeks—now takes minutes, sometimes even seconds. That’s a significant advancement, but it only scratches the surface. Once an instrument is in the library, it never needs to be built again.

We’re also tackling translation, which has been a major bottleneck in running global trials. Eliminating that barrier will bring enormous benefits. Leveraging AI-powered translation tools will further streamline the process.

Beyond these efficiencies, AI is reshaping how clinical trials are conducted. It’s not just about collecting data through eCOA—it’s about passive data collection via sensors and wearables, enabling remote, large-scale monitoring. Additionally, integrating with EHR systems and tokenization vendors allows us to gather richer patient data and answer research questions in new ways. These innovations are fundamentally changing the clinical trial landscape.

: Key factors contributing to success include a strong customer value team with expertise in clinical research, not just technology. The team addresses product adoption, therapeutic area strategies, and patient engagement. A critical element for success is designing trials with patients’ daily lives in mind, ensuring that tasks are non-burdensome and easy to integrate into their routines. For example, in a study with patients suffering from extreme fatigue, notifications were adjusted to be more accessible by changing the timing to align better with patient habits.

Additionally, Medable has gained Canal approval for operating in France, overcoming previous barriers like stricter data protection regulations. This approval enhances confidence in using electronic consent (e-consent) across global trials, improving data security and participant benefits. Furthermore, advancements in AI and tools like Medical Studio are transforming trial operations. AI speeds up tasks like building eco instruments, reducing weeks of work to minutes, and offers solutions to challenges like language translation for global trials. With digital platforms, the company enables broader, scalable approaches for clinical trials across various therapeutic areas. This shift from pilot studies to large-scale implementations aims to enhance trial efficiency and cost-effectiveness across entire portfolios, rather than focusing on individual trials.

Lastly, regulatory bodies are adapting to decentralized trials, with the EMA and FDA releasing new guidelines that support the integration of digital solutions. Despite some regulatory discrepancies, such as the stricter Canal regulations in France, the industry is moving toward broader acceptance of decentralized trials, ensuring that digital tools are compliant with data security and privacy standards. This approach promises to reshape clinical trial methodologies, making them more efficient and accessible globally.

Andrew Mackinnon, Executive GM, Medable, discusses how AI-driven innovations are streamlining clinical trials through enabling scalable operations. 

Video Series

Addressing Clinical Trial Challenges Through AI and Scalable Solutions

Medable Europe Digital Trials

ACT: Medable has played a pivotal role in decentralized and digital clinical trials globally. How do you see the company expanding its presence further in Europe, specifically with this new approval?

This is an interesting one because the new approval is highly relevant for global companies conducting work in France. That’s where most CNIL applications come into play.

This approval stemmed from our interaction with Servier. Companies like Servier consider CNIL regulations applicable to all their global operations, which is why we sought approval to operate in additional countries. To me, this approval unlocks significant potential.

We work with many companies looking to implement e-consent across their entire portfolio, believing it to be superior to paper. However, France has historically been a challenge due to CNIL regulations. As I mentioned, email is a core communication tool between medical staff and study participants. While we also use push notifications via a mobile app, I firmly believe email is the better pathway. Until now, CNIL regulations have been a barrier to this approach in French studies.

This approval doesn’t grant blanket authorization for all studies—each will still require individual approval. However, we now have confidence that CNIL has validated our medical processes. They’ve assessed our data security practices, GDPR compliance, and adherence to data minimization principles—ensuring we collect only the necessary personal information for each task. We met all these criteria. They also evaluated whether collecting this data benefits participants and determined our approach has a clear purpose.

On all three points, we met the standard and secured CNIL approval. This gives us greater confidence in operating within France, and we’re already in discussions with clients on how to replicate this approach. More broadly, this approval reinforces our commitment to data protection—a critical priority for pharma companies—and provides global validation of our processes.

 Key factors contributing to success include a strong customer value team with expertise in clinical research, not just technology. The team addresses product adoption, therapeutic area strategies, and patient engagement. A critical element for success is designing trials with patients’ daily lives in mind, ensuring that tasks are non-burdensome and easy to integrate into their routines. For example, in a study with patients suffering from extreme fatigue, notifications were adjusted to be more accessible by changing the timing to align better with patient habits.

Andrew Mackinnon, Executive GM, Medable, explains how the company’s recent approval in France could support the expansion of digital and decentralized clinical trials across Europe, particularly through enhanced e-consent practices.

Medable Eyes Expanded Presence in Europe with New Approval for Digital Trials

In this video interview, Cameron Breze, product manager, Inovalon, highlights current trends with decentralization and how a dual approach can ensure flexibility across different therapeutic areas.

Determining the Effectiveness of Decentralization Across Different Trials 

, Cameron Breze, product manager, Inovalon, discussed challenges in patient recruitment for clinical trials. Traditional recruitment methods, such as manual outreach, are now less efficient due to accessibility issues. Breze highlighted technology as a way to address recruitment challenges, which can be leveraged to automate and streamline processes, reducing labor intensity and errors.

ACT: Is the incorporation of decentralized elements and more remote trials helping with enrollment? Why or why not?

The efforts towards decentralized trials and remote patient recruitment are something that has been birthed out of recent changes in technology, but also socially and culturally, with the COVID 19 pandemic in 2019 to 2020, we really reframed, okay, how can we move research forward within particular constraints? I think it's always going to be a matter of what's the best fit. There are certain trials where that remote or decentralized approach might be best suited. You can think of, say, cream or an ointment for a skin condition where you could take a picture of it with your cell phone. There's no risk to your health in the long term. It's just something that might be visually disturbing you or affecting you mentally. Same thing with a lot of mental health conditions, where you could have therapy that's conducted remotely, or some cognitive behavioral combination of the two, plus an intervention. With that said, there are still trials that will essentially never be remote. There are a lot of more complex biologics that are being released on the market, where they're required to be administered through an IV or some other complex administration method where you have to be at a physical research site. It's not as simple as just taking a pill and then they'll monitor you and maintain that clinical connection as you move through the trial. I think it's something that people have in mind, and I think the most forward thinking organizations have a dual minded approach, where there will always be trials that are optimized for that decentralized approach, and then there are trials that will be better suited for powerhouse academic research centers and everything in the middle, because it will be quite a spectrum, and that will continue to evolve as we get new disease indications that are now accessible to treat. I'm very excited with a lot of the computational chemistry and computational biology methods that are coming out, where we can match, more specifically, to a lot of mild to moderate, genetically inspired disease and treat that through something like a biologic. All of that to say, that dual approach is what I think most organizations will take going forward, and it will continue to bear fruit, and we'll pivot and adapt as the industry moves along with us.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Pamela Tenaerts, chief scientific officer, Medable, discusses the need for more data around the implementation of clinical technology.  

SCOPE Summit 2025: Implementing Decentralized Elements

ACT: What are some barriers that stakeholders struggle to overcome when they want to implement more DCT approaches?

What I think, and why I think it's important to support groups and consortia that collect data is that we've had a lot of hype and hopes for using technology and modern clinical trial elements, but we don't have a lot of evidence of what it actually does, so this effort really gets us at that evidence where we start learning, how does it change protocol, performance, what should we use, where? Because as we get more data, we also know really well what the trials are that we're studying those elements, so we'll know what it's cardiology, in oncology, exactly what modules they use and exactly what outcomes they have so that when we start getting more data, I think people will know that it can get them what they want, and that I think there's hesitancy around is it really going to get me what I want? I think this is one of the elements. The other barriers that people might have had was regulatory acceptance, but I think in the last couple of years, we've gotten a lot of guidances indicating that, yes, the regulators are in favor of this, if you do it right. I think we've also gotten to better workflows and better products over time.

ACT: What are some other projects or initiatives the PACT Consortium is working on that excite you most?

What we've learned with PACT is that we had an initial set of metrics that we were calculating, and what we're finding is now that we're getting evidence of some of those elements, people are drilling down on those elements, so there's another layer of metrics that we will be exploring. I think that's the interesting part, is this is really like an onion, like in the first year, we started asking about the more obvious data elements of protocol performance and reaching the right populations and now we're getting deeper and deeper and it's really going to be fascinating to see what we're going to learn about what using technology in clinical trials does for us, just as much as how we use technology in the real world, right?

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Pamela Tenaerts, chief scientific officer, Medable, discusses the need for more data around the implementation of clinical technology.

Latest Conference Coverage

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Tenaerts, chief scientific officer, Medable, highlights the recent findings and how decentralized elements can improve access to underrepresented populations. 

SCOPE Summit 2025: Pamela Tenaerts of Medable Discusses Research From PACT Consortium Linking DCTs and Increased Diversity

ACT: Could you share your thoughts on the recent 

 from Tufts CSDD’s PACT Consortium linking the use of decentralized elements to increased diversity?

 I'm really proud of Medable’s support of the PACT Consortium. What we set out to do is to collect data on what using technology and decentralized elements in clinical trials would do and after analyzing about 70 trials, 20 of which do not have a database locket, so we don't have full data, we learned that there are some changes in the representation of the trials that use decentralized elements, and what we're finding is that we might have better access to certain groups of people that we know need to participate in trials, because the rule of clinical trials is that you should study the medical product in the people that live with the condition. Historically, we haven't been that great at it, and this is the way where we've learned that Asian populations are increased when using decentralized elements by about 50% from 14 to about 20% and that Alaska Natives and American Indians were actually almost four times as represented in clinical trials when using DCT elements. What we're learning is that we probably need to tailor the DCT element to the different populations we want to reach because, for example, African American participation was increased when you look to use local labs, so it's not going to be every element getting you better representation of everything, but what we're finding is that—and that was the goal too—is learning what the best fit-for-purpose solution is to get you what you want. The good news is it's not a binary decision you have to make, you don't have to choose for reaching the right populations. We also learned that when you deploy technology, actual timelines actually beat planned timelines, so there's an incentive for speed as well.

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