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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

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

Understanding Study Coordinator Work Quality

Addressing data integrity and compliance concerns.

Collaborative Strategies for Technology Integration in Clinical Studies

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, shares his key takeaways from Cencora’s recent TMF Leadership Summit and touches on the importance of oversight when working with outside stakeholders. 

The Importance of Clinical Trial Oversight when Outsourcing

, 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product manager, TMF practice area, Pharmalex, discussed challenges in the trial master file (TMF) space, highlighting outdated regulations such as ICH E6(R3).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: Cencora’s TMF Leadership Summit was just a few weeks ago. What were some key discussion points or trends that emerged from conversations there?

It was really good. Again, this is going back to my point about everyone being open and sharing, this was the nice thing. It was a group of us just being brutally honest about the struggles that we all face. There was one word that came up time and time again, and that word is oversight. It's something that has been in our industry for a long time. It's something that the regulation is now putting more pressure on, and it's also a word that I love, because, like many words in the English language, it has two meanings. One meaning is to oversee something, make sure it goes well, and the other is you miss something, and something bad happens. It produces this fantastic sentence that, again, in a lot of my talks, I like to bring it up on the screen, which is, “Without oversight, you risk an oversight.” It really says a lot that, again, in the past, oversight was just this idea of it's a tick-boxing exercise, but we're outsourcing more and more now. We're outsourcing to vendors, to partners, to just third-party groups in general. It's not always cost effective to do everything yourself in-house, and you don't always have the experience in-house, you can't have an A-team for everything you do. This idea of outsourcing is becoming bigger and bigger now the current regulations have really set that up as to what they expect, and in essence, what they're saying is just because you're not behind the wheel of the car at that moment doesn't mean that you should not be in control. You should be in control. You should be ready to correct when things go wrong. What we're having to do is really look at that support, really looking at making sure that it doesn't matter if it is, and this was part of what came up. It doesn't matter if it's a live trial that you're running today, and you're halfway through it, you've got loads of metrics, you still need oversight. It doesn't matter if you are getting to the end of the trial and you're about to receive it from a CRO partner. It doesn't matter if it's a trial that you never did, but your company has acquired that trial and that product, you need to prove oversight, and it's a real delicate balance, going too far one way, you're basically just doing the job that you outsourced, you're checking on everything, you're chasing people up, you're making sure that everything goes exactly as you think it should, and there was no point in outsourcing it, you've overstepped it. On the other side, what you don't want to do is just ignore it, and then when disaster does strike, if you're lucky, you know about it, but a lot of the time you don't even know that disaster struck you. You're oblivious to it, and unfortunately, regulators won't accept innocence. They will accuse you of ignorance at that point, so getting that balance and what we say a lot, is that idea of trust but verify, so when you're thinking about oversight, really think about what sort of checks you're doing. You don't want to do all of them, but how about a sample? You want to set your vendors up for success. You want to share ideas with them, and if you see something going wrong, don't wait for them to tell you, go to them, so have that two-way communication. There is no us in them, everybody's working towards the same goal, and yeah, that ultimately, over those two days that we had at our leadership summit, every talk, at some point, touched on oversight, and again, didn't matter what it was, oversight was still the thing that came in, and I think that's an area that again, as we move forward, as we think about what's happening and what's changing, it's going to become pivotal, especially when you're sat in front of that inspector and they say, “So, what did you do to make sure that this went well?”

Videos

Vendor Strategy & Collaboration

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, Dominique Demolle, CEO of Cognivia, discusses challenges that sponsors are currently facing with adherence and some strategies that can help address them. 

Improving Patient Adherence

, Dominique Demolle, CEO of Cognivia, discussed challenges in improving patient adherence in clinical trials. She highlighted the reliability of adherence tracking methods, such as pill counts and ingestible sensors, and the need for tailored patient engagement strategies. Some potential solutions to these challenges include the use of artificial intelligence and designing more patient-centric studies.

ACT: What are some challenges that you are currently seeing with sponsors trying to improve adherence? How do you think they can be addressed?

 I would say that probably one of the most important challenges is to have some kind of reliable way to manage other events and fair to say that it's really a huge challenge. If you think about, of course, some small sample size, you may have tactics like assessing the drug or metabolites level in the blood and you know if the patient has taken the drug or having some kind of, let's say ingestible sensor, for example, but as soon as you move to a larger sample size, especially in patient population, you are depending, really, on having the recording of the adherence made by the patient themselves; PROs, you may have a pill count, you may have even a device where you know if the bottle has been opened or not, but at the end of the day, you never know exactly what the adherence has been and for most, this is the biggest issue, and of course, the consequences will definitely be on your true evaluation of the track, efficacy and safety. It's really an enormous challenge, the way to some tactics that implement to address that will definitely vary significantly from different sponsors, but there has been recently tactics like having a running phase to try to predict if a patient is going to have a more adherent behavior. There are some limitations about that, we may speak about that later on, and definitely patient engagement strategy. I think we are missing some very, let's say, tailored patient engagement strategy. It’s still very general, so maybe being more focused on the individual to address a specific concern, or having a way to improve that adherence because of the socioeconomic situation of the patient, for example, would definitely help.

In this video interview, Rachael Fones, director, government & public affairs, IQVIA, discusses some of the key ways that different trial sponsors may need support in meeting diversity expectations. 

Supporting Clinical Trial Sponsors in Achieving Greater Diversity

, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of diversity action plans in clinical trials. Fones emphasized the need for understanding the intent behind goal setting, the ability to stay updated with FDA guidelines, and the importance of a robust population assessment.

ACT: What are some of the key ways that you are seeing small-to-mid-size pharmas, biotechs, and medical device companies may need support to meet expectations and make tangible progress in improving diversity in their trial programs?

So much of the work that we do in advising sponsors on diversity action plans and how to meet the expectations of the FDA in context of their overall trial goals or overall program goals, is really helping them, the individuals within the team, who are all coming at it from different perspectives, really understand not just the why from a social justice standpoint and health equity standpoint, I think everybody understands that, but what the intent of the goal-setting and the process and that truly, this is not just about the numbers, it's not just about improvement. It's about learning and it's about showing the work, putting in the effort, exploring the populations and what the impact might be, so that you can then set those meaningful goals. I don't know that you could say that this is a difference between small, medium, and large because we're all talking to individuals within a sponsored company. It just might be the difference of where that sponsor is in their journey and where the individuals are and understanding this, but it's really important to help the operational people feel comfortable that what's being set is achievable. It's helping the regulatory team that may or may not have experience on this, fit this in with other regulatory documents. This is not something that's set in stone, it is evolving. It's really marrying that. Where did the policy intent for setting goals and doing the diversity action plan come from, and then how does that work within the context of your trial? Being able to answer those questions and help the sponsors proceed with that confidence, that what they're setting is meaningful to the efforts that's acceptable to regulators and achievable for their operational teams is really a key value add that we can provide.

What we're going to see is, with it becoming required, is the volume of diversity plans will, of course, match the volume of your trial. Some sponsors may have several trials launching at once and not be able and by several trials launching once, maybe one promising product that they're trying on different populations, which will necessitate different population assessments to get to those goals or they only do one every year. Being able to utilize and tap into others who do these on a regular basis, we're able to stay on top of what the FDA is saying and what they're doing, and again, marry it with what we already know and what we're seeing, and leverage those efficiencies. That said, doing the diversity plan efficiently is great if you don't have that cross-functional team and SOPs built up to do that, but really doing it right to get your trial on the right track and bring that value-add is where I think it's really, I found, it's really helpful for us, even working with large sponsors, everybody's approaching these differently. I think we're all learning from each other, but I can say, our approach to that population assessment is really robust.

Lastly, like I said, it's a moving target. It's going to continue to change. Different reviewers are going to have different feedback. It's really important to understand those nuances, and we at IQVIA have been in a position that if we work across different sponsors, we're able to leverage those insights and deliver plans, again, that are built specifically for the sponsor in that program, yet are acceptable to regulators and implementable on the outside. Hopefully, as this gains traction, what we will see is all sponsors and folks involved in drug development start to see that value, gain that comfort with diversity planning, and it just becomes business as usual.

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, touches on how therapeutic area can affect which labs a sponsor decides to work with.

Choosing Different Labs Based on the Therapeutic Area of a Study

ACT: How does the therapeutic area of focus for a trial and the related patient population steer decisions on when a sponsor should rely on central labs versus local labs?

 This is really the big key, from my perspective, on what is driving the use of central versus local labs. As we talked about in the first question, the driver, a lot of times for local labs, is that quick turnaround of testing. If you have an oncology study where those patients’ safety values have to be monitored on a regular basis, the results of those tests are going to drive and impact their patient treatment and inform patient treatment decisions from that investigator. We see a lot of local lab use in oncology trials. Those patients are very, very sick. They need those test results turned around quickly, and therapeutic areas like that, where we have a sick population of patients that are more fragile, I would say, then some of the other therapeutic areas, but that's a big driver that we see from a central lab perspective, that would drive the use of local labs for that patient care.

In this video interview, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, highlights best practices for data standardization and consistency.

Ensuring Consistency with Lab Testing

ACT: Depending on the complexities of the clinical trial, especially if it’s a global study, how do central labs help ensure data standardization and consistency across lab testing needed for a trial?

 As stated, the globally harmonized and broad test menu is really where our focus is. We have the ability to harmonize across all of our labs. IQVIA Labs has labs around the world. We are a global company. We have testing labs in many of the countries that we work in, and so having a test menu that is the same, the sponsor is going to get the same test no matter which of our labs that that test is being performed at. All of our tests follow globally harmonized standard operating procedures, and we ensure that we are harmonized to the requirements of the protocol. That's really the focus, and also the broadness of our test menu, we have the ability to perform testing across the spectrum of what could be needed in a clinical trial.

In this video interview, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discusses the different types of labs in clinical research and what they offer.

The Roles of Central and Local Labs in Clinical Trials

ACT: What are some of the key aspects of each type of lab that are important for clinical trials, sites, and sponsors?

 In looking at clinical trials from a central lab perspective, the key benefits are really around the globally harmonized test menu, so the reference ranges are aligned, any flagging that is necessary, the data collection, the data provision to the sponsor—all of that is aligned and harmonized across all of our various labs. The central lab kit supplies, so anything that a site is going to need to be able to collect a sample is all provided, hopefully in a nice little package, depending on the central lab I guess you're working with. Really, the benefits, a focus of sponsors, and making sure that we're providing everything that the site would need and primarily focusing on everything that is needed to provide patient care, start to finish, in a collection or in a visit.

From a local lab perspective, a lot of these labs are close to the investigator sites. The investigators are familiar with them. Sometimes they are physically at the investigator site, if it's like a large hospital or a large facility. They provide fast turnaround time. The lab is within your facility, you're able to get those results quickly and inform patient care. Sometimes, in some scenarios, that can be really critical for the patients, to get those results back quickly, and just making sure that the investigator has everything that they need in a timely manner. The investigator sites also often are very familiar with these local labs. They work with them on a regular basis, a lot of times in their non-clinical trials, if they have just routine testing that they're doing, they're working with these same labs that are providing this testing for them.

In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, discusses the importance of communication between CROs, sponsors, and sites. 

Building Relationships in Clinical Research

ACT: Another topic we’ve heard a lot about recently is relationship building between CROs, sponsors, and sites. Why is this so important and what are some best practices for building these relationships?

 Absolutely, it's a good question, and one we talk about a lot actually with SCRS and our partners, because it's kind of foundational in a way that's critical to the successful execution of clinical trials long-term and building relationships. There's so many benefits that can come out of appropriately-built relationships, and so many of the issues that we see, even the one that I just spoke about with technology, can be at least moved in the right direction, if not solved by building effective relationships and communication. Even examples of your personal life and failing at relationships in your personal life, a lot of it can be traced back to poor communication, so asking and having that discussion early on in that relationship, checking in with each other on how to communicate, and developing and sticking to a communication plan is a really great way to build a relationship, and I think there's a couple of important components to that. It doesn't really help to create a communication plan, or establish that understanding if you don't use it or stick to it, so that's a really important part. Coupled with that is reapproaching that communication plan, because you're going to probably work with a completely different team at a given organization, so just because a communication plan worked on one trial doesn't mean that it's going to work on the next trial, or it might need some modifications, or again, just revisiting it is healthy for any relationship that you're trying to build. Part of that, I would say also, is being as transparent and honest as possible. If we can start to break down some of those barriers and stop treating the relationship as ‘us and them’ and more of ‘we,’ it sounds cliche, but it's still happening. We're still kind of holding our cards pretty tight to our chests and not helping each other understand, “Yeah, I am struggling as a site. Yeah, this isn't easy. This screen failure is a challenge for me. I'm not going to be able to meet those enrollment numbers” or from a sponsor, “Yeah, if you ask for that, we probably can approve it or, no, we're not going to be able to improve it for these reasons or maybe if you asked it in a different way, we might be able to approach that or consider it, or get approval for it.” So stop treating it like this hidden relationship and again, as you heard from my examples, it goes both ways. There's work to be done there by the site—just like any relationship, professionally or personally—the sites have to come to the table as well as the sponsors and CROs have to come to the table to build those effective relationships and they take work. It's not just something that you can establish at the beginning and expect it to—over the course of a couple of years—as many clinical trials go, work without a hitch.

In a fireside chat with ACT editor Andy Studna, Bowdish, from a clinical research cancer center, shares her experience with these relationships and how to streamline clinical operations. 

2024 Veeva R&D and Quality Summit: Tina Bowdish Highlights the Importance of Site-Sponsor Relationships

ACT: You’ve been in the clinical research industry for more than 25 years. Can you please tell us a little about your experience?

 Yeah, I've been in research for more than 25 years, and I have held just about every role you can in clinical research that doesn't require a license. I'm not a nurse, I'm not a physician, but I have worked at three academic medical centers now, a couple of pharma companies, and a CRO, so I have seen it from all three sides of the table over the last 25 years.

ACT: Having worked on the execution of trials and partnered with other sites and sponsors, what opportunities do you see to improve the way sites and sponsors work together?

 Communication and relationships are really the biggest area, and I think as a society, sometimes we forget that relationships are really important, especially in this work from home era where everything is done via Zoom, so conferences like this are great to be able to make those connections. It’s kind of the press the flesh, but it's reminding you that we're all serving a common goal, and we're all human, and we're all working together. One of the areas, specific into the communication, is just making sure that that communication is streamlined, it's getting to the intended audience, and then it's truly understood. That goes both ways from sponsor to site and from site to sponsor.

ACT: If there is one piece of advice you would give to sponsors to make life easier for sites, what would it be?

 The one single piece of information I could give is to truly be ready when you are approaching your sites to launch a study. It's great to go to sites before you're ready to launch that study and get their feedback, but when you're trying to initiate a trial and get that trial started, when the sponsor or the CRO doesn't have all of their individual vendors and all of their documents completed, it makes it really difficult on sites, and it only lengthens the process of our startup. If we could make sure that we are truly ready before we are approached about a study and to get started on that, I think we could significantly cut down on the long timelines for startup that exist in our industry.

ACT: In your experience in research, how have you seen the enablement of site-sponsor collaboration, and could you share any examples?

 Yeah, so it's really at these conferences. It's having these roundtable discussions and tackling issues that have been around for 25 years. They've only become more challenging with technology and trials becoming more complex, so it's really tackling how can we do this for the patient? Everything that we do has a patient or a subject at the end of the day and that is why we all got into this industry in one way, shape, or form. We had a session this morning where we talked about how can systems across different sponsors and all the multiple systems that are used in any given trial be streamlined to make it easier for sites so that we can spend more time with those subjects?

ACT: What are some aspects of a clinical trial that you can prioritize to streamline operations?

 This is a difficult question, because every study is different. As I just said, trials are becoming more and more complex. Science is exponentially getting better, but that makes it harder and harder to find patients because your populations are narrowing down. If we can ensure that we keep a patient-centric approach to designing these trials when we're in protocol development, and thinking about what are the patients or the subjects going to be doing at a given visit at a particular time, and then taking into consideration what that population is, is it a rural population that doesn't have access or stable access to internet to be able to do e-questionnaires from home, or something like that? Is it a population that has to drive for 500 miles to get to the next site because they have a rare disease? What can we do in a remote basis? What can they do locally? How do we tackle that as an industry, because who's responsible? Is it the site that's responsible? Is it the sponsor that's responsible? I think the ultimate answer is we all have to come together and we both probably need to take a little bit more responsibility in that and work towards that goal.

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