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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

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

The Latest Advancements in Single Sign-On Technology

Strategies for ensuring that innovation with PROs remains parallel with advancements in disease detection and progression.

Modernizing Patient-Reported Outcomes:  Bridging the Gap Between Legacy Measures and Contemporary Healthcare

With close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.

Clinical Strategies to Optimize Software as a Medical Device to Treat Mental Health

The challenges, opportunities, and strategic outlook for oncology research centers. 

Scaling eSource-Enabled Clinical Trials: Hospital Perspectives

Leveraging artificial intelligence-powered stochastic methods for clinical data review represents a significant leap beyond traditional approaches.

Revolutionizing Clinical Data Management: The Leap from Deterministic to AI-Powered Stochastic Methods

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, talks AI and how change is needed for the clinical trials industry to fully understand its potential with automation.

A Roadmap for the Use of Artificial Intelligence in Managing Trial Master Files

, Rob Jones, product manager, TMF practice area, Pharmalex, discussed challenges in the trial master file (TMF) space, highlighting outdated regulations such as ICH E6(R3). When it comes to innovation and compliance in the space, he stressed the importance of a risk-based approach, focusing on critical records and leveraging artificial intelligence for big data analysis. Moving forward, Jones believes the TMF community's collaborative nature can be viewed as a strength in navigating regulatory changes and technological advancements.

ACT: How are recent regulatory changes allowing for more advances with technology and AI?

The short answer: they haven't. That's the short answer of it is they haven't really embraced this idea of AI. They're talking about it now. They're talking about these new technologies, but we're still in a world where we don't want to commit to this idea of with a TMF, you have to manage it electronically. You can run an entire trial today in paper and the regulations for that, the requirements for that, are down here, whereas if you say, “Oh, I'm doing it electronically,” they're up here. The simple answer is they haven't, but that doesn't mean that they've also said we can't use them. What they've started to do is tease with that idea of AI coming in, tease with that idea of new ways of working, and I think our industry is ripe for opportunity. Within our TMF service group alone, we're managing thousands, tens of thousands documents a day. You scale that up by weeks, months, years, we're talking millions of data points. That's ripe for AI, that's ripe for all these things that we've seen and I think the thing we need to look at, really, is just sensible ways of how to use it. On one side, we can really look at having a look and saying, “Okay, what about automation? What about processes and new solutions.” Electronic TMFs were an interesting new technology in that the fear mongering of the 90s was computers were going to steal all of our jobs. I actually feel there's probably more jobs in TMF today because of the electronic TMFs than there were when it was paper. We've already brought in different ways that we're using AI to help identify records as they're uploaded, and give suggestions to people of: “We think you should file it here, or this looks similar to these documents you've filed over here.” Using it in that way has those benefits for us, and again, there's nothing that says we can't utilize these.

The second biggest area is big data. Again, millions of data points here, that's before we even start coming into metadata and all the other stuff that we collect, so these things that are coming up now in in a lot of other industries, of AI agents, being able to ask, “How's this going in this country? What am I missing over here?” and having something that has that holistic view that can guide you, it's not going to replace anybody, by any stretch, but it's definitely going to help us. I think really, there's a real opportunity here for someone who's willing to push that boundary, someone who's really willing to be a first mover. AI isn't scary, the current trend going around that I've seen on LinkedIn is everyone's turning themselves into action figures. That's not scary. There's fun to be had, and there's interesting ways we can use it. I think the thing that we're going to have to bring in, which is the scary part, is a lot more logical thinking. A lot of the time we've been used to old ways of computerized system validation, which is: “I've got requirement, I have got an expectation of when I push this button. This happens.” Can't test AI in those ways. Some things you can, but there's a lot of things we can’t, so it's going to be coming up with new ways to test it, new ways to utilize it, obviously, thinking about the security and the privacy and those things are going to be paramount for us in this industry and clinical trials, but there's real opportunity here. Again, although the recent regulations don't suddenly open flood gates and don't give us a step by step on how to use it, they also don't say we shouldn't use it, and they also don't prohibit it, and I think it really is waiting for that person to take that step forwards and say, “No, this could make a difference,” and go for it.

Videos

In this video interview, Rob Jones product manager, TMF practice area, Pharmalex, discusses challenges the TMF space is currently facing and how it can utilize collaboration in making advancements. 

Battling Outdated Regulations in the Trial Master File Space

ACT: What are some challenges the TMF space is currently facing? How do you think they can be addressed?

It's a nice, broad question. I think really the biggest challenge is keeping up. I think right now we've got new regulations coming in, things like ICH E6(R3) have finally come in this year, after being delayed for a little bit because of other things that were going on in the early 2020s. We've got new proposed standards from the reference model with V4 and all of this while trying to balance that desire for innovation, cost effective solutions, just an ever-changing landscape. I think one of the things that we have to look at and admit is regulations have been a little out of step for a while. We were expecting ICH E6(R3) months, if not years ago, but again, due to things that got delayed. That's fine, but a lot of things have already passed it by. The EMA has already put in new guidelines around their perception of the TMF. They had a brilliant new guideline around computerized system validation, which included things like the electronic TMF. The MHRA have been giving us more and more feedback on their current public forums and Q&As and things like that. It's kind of a little too late in some ways, ICH E6(R2) came out in 2016, and even then it was only a small look there in the grand scheme of things, realistically, it was written back in 1996. I don't need to tell you how much has changed since 1996. My marker for a lot of these things when I talk with people, is the first iPhone came out in 2007, so anything post-2007, you have had constant satellite communication world in your pocket. We're an industry that's built on stability, order, organization, we're managing clinical trial documents, but this new world hasn't been that for a long time, it's messy in a lot of ways.

The challenge really is, what do we do when the regulations are a little bit too old and outdated? How do we manage when other industries, especially outside of clinical trials, are just flying by, and what can we do to keep up without jeopardizing people's comfort, without jeopardizing all of the hard work that's gone into it? I think the nice thing really, with the TMF, and this shows every single time I go to a conference. It is one of the very few parts of clinical trials where it's an open book. There is a real community behind everything. Everyone's talking to each other. You go and talk with people, and they will tell you that TMF stands for “too much fun.” They'll tell you that TMF stands for “too many friends.” There is really this idea of everyone's in it together. I think the nice thing with that is that's been built from the beginning. The reference model when it came up was sponsors, CROs, vendors, consultants, all working together, sharing what they were doing. Nothing was secret. Nothing was hidden behind closed doors. I think, really, that is the biggest strength, and that's how we can address this ever-changing landscape, if we all come to get together and make a bit of a collective decision and say, “We as a group are going to make an interpretation of this, and this is how we're going to take it forwards.” There's a little bit where perception becomes reality, and if we're all pushing in that same direction, that really helps with how we can address all of this. I think, again, just for the TMF world, that's really how we're going to get by with these things changing at such a rate. It's one of the biggest strengths of our little, niche part of the industry.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, discusses challenges the TMF space is currently facing and how it can utilize collaboration in making advancements. 

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discusses how artificial intelligence can aid in bringing therapies to rare disease patients faster. 

Leading the Technology and Innovation Front Through Rare Disease Research

, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discussed the unique challenges in rare disease R&D, including competing priorities among researchers, difficulty in diagnosing and treating patients, and defining endpoints due to varying symptoms. Ansel also touched on the potential of technology and artificial intelligence to address some of these challenges and improve rare disease research.

ACT: Looking forward, what advancements or changes would you like to see in the rare disease space to make research more efficient and effective?

I think fixing all of the items that I've already mentioned would be of utmost importance. Again, increasing greater global collaboration across the various stakeholders, I think, will always be critical. Rare is challenging. Rare is difficult because of, in essence, what a rare disease is, but I think if we can lay the framework around that global collaboration and working together really helps the next disease community pick up where other leaders have laid the ground there. I'm really encouraged by the use of technology and of AI (artificial intelligence), I'm very much of a skeptic when it comes to that type of technology for various reasons, if you’re interested, happy to discuss more, but I think for a community largely that's been built by technology in its very essence, parents and caregivers have created drugs because of the challenges we see in rare disease, communities have been born because of the internet and the ability to connect directly with other patients as a necessity, because those communities otherwise wouldn't exist. Rare disease, I feel, really leads the technology and innovation front in rare disease research, so I'm really excited to see how they are going to be using AI, whether that's helping diagnose patients faster by looking at pictures of children with dysmorphic features to help get a diagnosis earlier in life, or by using AI, there are various companies out there that are linking the various approved drugs out there. Could they be used to support and treat and increase quality of life in patients who otherwise wouldn't have access to those drugs, and that's really being leveraged by AI, instead of having humans mine through those various datasets themselves in a very manual way, can leverage those technologies to connect to researchers and connect patients to drugs faster.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, highlights the need for maintaining data privacy in a highly regulated clinical research industry.

Maintaining Regulatory Adherence with Clinical Technology

, 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: What would you say to stakeholders who are still unsure of implementing more clinical technology?

I think it's very much beyond, I would say, the technology itself because, as we can see we are able to speak to each other. I think we have, maybe the Atlantic Ocean between the two of us, and we are still able to interact as we were in the same room, so the technology is there. It's more the question of data privacy in particular, I would say, for patients in using those technologies, we have to ensure that the data privacy is respected. In particular, that for the pharmaceutical sponsor, they shouldn't know anything about the patient identity that should be disclosed and things like this, so there is some of the regulatory, ethics, also difference between, I would say, all countries. Even I would say we have the global ICH E6 that is defining the way clinical studies should be run, but each country may have this their own ethics, let's say mindset, as well as data privacy and therefore, of course, there is sometimes also that fear from the pharmaceutical sponsor side is that, if I'm doing something brand new, is it going to be accepted by the regulatory when I will submit my dossier? That's why, very often the technology is very much, I would say, on line, with the technology of daily life, like even you can look to your bank account, I would say, using the web and so on, and you can interact with friends, but then, as you know, clinical trials are so regulated for the sake of protecting the patient and also the quality of data, that sometimes pharma, I think, is a little bit anxious to move towards those technologies until there is maybe some new guidance. As everyone had to deal with the pandemic crisis, with COVID, of course, there was an increasing speed of trying to adopt some technology, because no one was able to travel anymore, even the patients, they were, I would say, less accepting to travel to the to the sites. The monitors were not able to go anymore to the to the sites to review the source documents, so there was some attempt to try to look to the source documents, but depending on the countries, it might be very difficult. Now that we are back in what I would call a normal situation, after, indeed the very high increase of using technology during the pandemic, there was almost not a shift, but okay, let's come back to what we know, what we master, and let's see how the regulatory will help us, so that's why some of the recent guidance, the one from the EMA and the FDA regarding decentralized components is helping very much the pharmaceutical industry, as well as the CRO service provider and the tech provider to be a little bit more comfortable in the way they can think on implementing those new technologies, but yes, clinical research is a specific word, with a lot of concern for protecting patient data and making sure that you have no deviation, that you have a harmony between standardization across all sides, and of course, depending on the country, it might be very different.

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

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses industry’s next steps in being able to maximize the benefits of virtual models.

Executing with Clinical Technology

, 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: Looking forward, what do you think are the next steps for industry in closing the gap between the need for technology innovation and actually being able to execute with it?

I think it all is going to come down to education and getting our customers comfortable with how new models actually work. It is embracing new technologies that are out there, perhaps it's doing a pilot or doing a softer launch of it, but that way to be able to see that. Number one, it's really not that scary. Number one, it's going to solve your data depth issue, it's going to solve your patient retention issue, it's going to solve your budget issues, just giving it a test trial, if you will. I think that that really is the only way that we're going to be able to do it. When I looked at the results of this report, I saw that 61% of them are already using some type of virtual model in AI, and to me, that's a huge opportunity, because, there's 40 something percent of them that haven't, but I think it's because they truly don't understand what they are, but being open to that, really understanding that there isn't just one way to do things, there are so many other ways to do that, to do what it is to get to your final outcome. Then also, I think, working with regulators, so that regulators become more and more comfortable with the ability to leverage AI and some of the other technologies to get to those endpoints as quickly as possible, to again bring medicines to patients, which is what we're looking to do.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, highlights how addressing these challenges can aid industry in moving more towards the future.

Addressing Data and Patient Retention Challenges

ACT: How can industry address some of the challenges holding it back from moving towards the future such as incomplete data and patient retention?

I think for companies, the life science partners that we do have, I think they truly need to not only say that they're open to things like virtual trials, but actually to be able to embrace them and actually take that leap to be able to do more of that, because that really is the only way to truly do things like getting access to the universal patient record by having patients consent directly, allowing you to get access to their medical record. It is a way that's no burden, or less burden to the patient, and then also give something back to the patient. Things like allowing patients to get access to their medical records and to be able to share their medical records, to be involved in the research, things like that are really going to certainly help them be able to scale up in the ways that they need to be able to do. When you think about all of our customers who are out there and the challenges that they have, I think they're all solvable. I think it's just getting them comfortable in the fact that the old way doesn't have to be the only way, right? There are certainly many ways to skin a cat, and I think these new ways certainly have proven to be effective. I think, again, it's just taking that leap. And then certainly, when you think about where the future is actually going to, the R&D costs are rising tremendously year over year. You see it in the news constantly with our life science partners having to make very significant cuts with not only their staff, thinking about their pipeline, what it is they're going to do, so they have to do more with less, and again, leveraging some of these types of models, virtual opportunities, leveraging direct connection to the patients, leveraging AI, that's going to be able to address their problems, which is going to allow them to scale in the future, which is really what everybody wants, which, again, at the end of the day, is going to be able to bring medicines to patients, which is really what we all want.

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

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, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the identification of current challenges being faced by the industry.

Implementing Virtual Models in Clinical Trials: Results from PicnicHealth’s Annual State of Observational Research Report

ACT: Could you tell our audience a bit about the 

 and highlight some of its most noteworthy findings?

The research report that PicnicHealth ran basically shows that the industry is definitely at a turning point. The stats show that 80% of the leaders that we interviewed are either using or they're open to virtual models. I think the exact number was 78% and I think this is happening because they are number one, getting pressures from the regulators, payers, and patients for number one, real-world data. They also are leveraging AI and tech-enabled solutions to be able to deliver this in a more systematic, efficient way. If I look at all the stats that were out there, I think one of the major stats that came out is data completeness, and this is the industry's biggest hurdle, 64% of them said that incomplete data is their top challenge and if you think about traditional methods, like a site-based study or a traditional chart review, it just isn't able to deliver that data completeness or capture the entire patient record, if you will, which is why they're actually looking for other options for that. Another area, which again, is no surprise, is patient retention, the loss to follow up with any trial, is one of the biggest issues for life science partners, and they are looking for ways to actually solve that, so having a direct connection to the patient is one of the ways that can increase keeping patients engaged, which then, in turn, would, obviously, enhance the retention. Another thing that we highlighted was 60% of leaders actually flagged that long-term follow up studies was a top priority for 2025 and we know that there are so many pressures and demands on life sciences with all of the cost-cutting measures that are happening, so they're looking for innovative ways to do that. Then last, but certainly not least is AI. If you think about some of the releases from JP Morgan, if you think about some of the questions that folks had answers with our survey, they are having a lot of pressure to leverage AI, not because it's the fun thing to do, but really because it is an innovative, efficient way to really be able to hone in on what it is that you're looking for and then get those answers really quickly. I think 61% of them are either using it or open to actually being able to do that.

In this video interview, Rachael Higgins, chief commercial officer, PicnicHealth, discusses findings from the report and the industry's willingness to adopt technology.

Enhancing Patient Engagement

ACT: Medable has achieved impressive results, such as 90% eCOA adherence. How do you ensure such high levels of participant engagement and data accuracy in decentralized trials?

On the customer value team that I run, there are three key pillars. I mention this because all three are crucial to delivering these kinds of results. My team has extensive clinical research experience. While we may not be the technology experts in the company, we deeply understand clinical research.

One of our groups focuses on product adoption, ensuring that our customers can effectively use the technology. Another pillar is therapeutic area strategy, which examines how our platform performs in different types of studies—whether in oncology, vaccines, or respiratory diseases. We consider the unique nuances of each indication and ensure that study designs align with the needs of specific patient populations.

The third pillar is our site and patient engagement team. We operate under the belief that successful studies require both supported sites and engaged patients. If either element fails, issues arise—often in the form of poor patient adherence and retention. Our site engagement team plays an integral role in all our product development efforts.

Recently, we’ve been re-envisioning how sites interact with our platform. This team has spent extensive time consulting with site staff, nurses, and research coordinators to understand their workflows and challenges. By doing so, we design solutions that genuinely work for them. Even though sites aren’t the buyers, they’re a core user group, and we must ensure our tools are intuitive and effective for their needs.

We apply the same level of engagement when working with patients. For each study, we consult members of our advisory council who have the relevant condition or a similar experience. We ask targeted questions: Would this study design present challenges? How does your condition affect daily life? What obstacles might arise in this workflow?

For example, we recently worked on a study for Sjögren’s syndrome, where fatigue is a primary symptom. Our initial design included compliance notifications prompting patients to complete tasks. However, patient feedback revealed that many wouldn’t be awake to see the alerts. Based on this insight, we adjusted the system—sending one notification earlier in the day and another mid-window when patients were more likely to be awake. This change significantly improved engagement.

We take a patient-centered approach, considering how they live, how their condition affects them, and how we can design studies that fit into their daily lives. Additionally, we ensure that notifications are delivered in the most effective format. A quick push notification might be dismissed immediately, whereas an email can be bookmarked and revisited later.

Our goal is to create a seamless, consumer-grade experience that makes participation easy and intuitive. When you combine clear communication with a frictionless user experience, that’s where the magic happens—it’s our "secret sauce." Many dropouts don’t occur because patients don’t want to comply; they drop out because the process is too burdensome. By reducing that burden, we ensure higher adherence and engagement.

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 ensures high patient participation and data accuracy in decentralized trials.

Technology

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