In the next episode of Clinical Trials Spotlight, Andrew Pucker, OD, PhD, FAAO, sits down with Joanna Williams and Nicole Derthick, both of Mintra Health, to discuss their unique experience building contract research organizations (CROs) from the ground up. The conversation highlights what is required individually and organizationally to ensure success for a CRO in the midst of an evolving biotech space.
Andrew Pucker, OD, PhD, FAAO:
Welcome to Clinical Trials Spotlight, the podcast where innovation, research, and patient care comes into focus. I’m Andrew Pucker, Chief Development Officer at Mintra Health, and your host for this series exploring the latest developments in optometry and ophthalmology clinical trials. Each episode, we’ll sit down with leading clinicians, researchers, industry experts, and innovators shaping the future of eyecare. From emerging innovations in study design, patient outcomes, and regulatory insights, we’ll take you behind the scenes of the clinical research transforming optometry and ophthalmology.
Whether you’re a clinician, researcher, industry professional, or simply passionate about advancing vision science, this podcast is designed to bring you thoughtful conversations and practical insights from across the ophthalmology and optometry community. Clinical Trials Spotlight is co-produced by Mintra Health and Ophthalmology 360 and Optometry 360. Thank you for joining us. Let’s get started.
In this episode, we’ll discuss the strategies, challenges, and innovations shaping the future of ophthalmology-focused CROs and what separates good organizations from truly exceptional partners in clinical research.
Today’s guests, Nicole Derthick and Joanna Williams, have something rare in common. They both built CROs from the ground up. From early strategy to scaling operations, each of them has firsthand experience turning a vision into a successful CRO. We’re diving into what it really takes to build, grow, and lead a CRO in today’s biotech landscape. Nicole, could you please give a little intro about yourself?
Nicole Derthick:
Absolutely. Thanks for that, Andrew. I’m Nicole Derthick, the CEO at Mintra Health. I’ve been in clinical research for over 20 years now, always on the CRO side and in operations. I moved over to ophthalmology at the beginning of 2019, and I’ve been there ever since. Started at Mintra about two and a half years ago.
Andrew Pucker, OD, PhD, FAAO:
Thanks for that, Nicole. Joanna, could you please give a little intro for yourself as well, please?
Joanna Williams:
Thanks, Andrew. I’m Joanna Williams. I am the chief operating officer at Mintra Health. I have been in clinical research for over 25 years, always also on the CRO side of things. Spent a lot of time at larger CROs in technology, was one of the co-founders and chief operating officer of a small ophthalmology CRO that started in 2011, and I’ve been in ophthalmology ever since.
Andrew Pucker, OD, PhD, FAAO:
For those of you who don’t really know, a CRO is a contract research organization, and what they do often is research for other companies. If you think of your big drug company, they don’t always have the resources in-house to do everything they need, or maybe they just don’t want to. They hire an organization like Mintra or a CRO to fill in the gaps, and maybe it’s for the whole study or maybe it’s for just a small part of that. Pretty complicated. When I first got into the space, I don’t know if I want to say confused, but I was pretty impressed by how many different things happen in this CRO space.
Nicole Derthick:
That’s a great point, Andrew. There’s a lot that goes on behind the scenes that anyone outside of the CRO is completely unaware of.
Andrew Pucker, OD, PhD, FAAO:
Yeah. That’s what we want to talk about today. We want to learn about what happens behind the scenes and how do you make a great CRO. Kind of to start, what is a CRO and then how is a CRO different in the ophthalmology space? Joanna, what do you think makes ophthalmology such a different animal in the clinical research space compared to maybe heart or cancer, one of those things?
Joanna Williams:
Yeah, it’s a really good question. I’ve been thinking about when I first started in ophthalmology coming from sort of a general… I was at a big CRO. We worked in all indications and I hadn’t worked in ophthalmology before. I remember thinking, how can a CRO just do ophthalmology? It’s just 1 tiny thing, but it’s so highly complex and highly specialized, even within the eye, you have specialists within pieces and parts of that. It took a while for me to understand. Being in it, I can see how when I joined ophthalmology, everyone’s like, it’s just different. It’s just different. We need a specialized CRO to understand what these assessments are, what the language is, what are these disease areas. I think to explain it to someone not in ophthalmology, it’s really difficult to do, but once you’re in it, you can really see how highly specialized it is, very different than a general medicine therapeutic area.
Andrew Pucker, OD, PhD, FAAO:
Yeah. I think that 1 thing I think is interesting is that there’s also kind of camps within ophthalmology and optometry, right? There’s front of the eye and back of the eye and maybe they meet but maybe they don’t.
Joanna Williams:
They don’t. Yeah.
Andrew Pucker, OD, PhD, FAAO:
Awesome. Nicole, we’re building this specialized CRO. What do you think are the most important points of that? What do you want in this specialty area for your CRO?
Nicole Derthick:
Sure. I can go back a little bit and Joanna referenced just general therapeutic areas and general CROs and I’ve done that too. I did that for a long time. There are a lot of therapeutic areas that are very, very easy to learn. You don’t need a background. You can pick it up for the first time and successfully run a trial and completely understand everything involved. Ophthalmology is not that. It takes many, many years to understand the nuances and the complexity that goes into an ophthalmology clinical trial.
All of our team here at Mintra are specialized. They’ve been doing it for a long time and that’s really important to the sites, which means it’s important to the patients and it’s important to the sponsors. When you send out someone to a site that doesn’t know the language, that doesn’t understand what they’re looking at, it creates big problems in accuracy and efficiency across the board. It causes issues in reporting data and understanding when there’s an issue. If you don’t understand really well what you’re looking at, it’s very easy to miss a trending concern or issue that’s happening. Perhaps there’s an issue with the trial design or a particular site or one of the inclusion-exclusion criteria. If you’re not trained very, very well and with many years of experience, you’re not going to recognize those things.
Andrew Pucker, OD, PhD, FAAO:
Yeah. I like to think about it as a credibility standpoint as I think you’re kind of alluding to. Like a CRO is the arm of the company that’s sponsoring the trial, right? If you have a person going to a site on the sponsor’s behalf saying myopia instead of myopia, which is the most common eye condition in the world, you look bad, right?
Nicole Derthick:
Yes, exactly. Exactly. We’ve heard that a lot over the years. Like I said, everyone that works with us, they all have many, many years of ophthalmology experience under their belt. That’s definitely a plus, but it’s not something that you can just send out a generalist to review or look for trending concerns.
Andrew Pucker, OD, PhD, FAAO:
That’s kind of one gap. Nicole, are there other gaps in ophthalmology space that maybe not every company can fill that a specialized ophthalmology CRO can?
Nicole Derthick:
I also think in the specialized ophthalmology CRO, not just with the ophthalmology training but training in general. At a generalist CRO or even with a different therapeutic area, it’s easy to take someone new to the field, train them on the ground, train them at the site and launch them out there to do their own thing within a couple months. That’s just not the case with us. You can, they need to have a partner with them for a long time while they’re learning all the complexities. There are quite many steps more in monitoring and managing a clinical trial. We’re talking about the site, which one would assume we’re referencing monitoring, but this also applies to the project manager’s role. It’s really critical that your project manager also knows what they’re doing often for lessons learned as well. They’re going to draw a lot from things that have happened with supplies or assessments or inclusion-exclusion criteria, just overall study management that really helps to go into navigating the management of future trials.
Andrew Pucker, OD, PhD, FAAO:
That’s awesome. I think there’s been a lot of change in this space over the last 10-plus years, especially around the COVID times. Joanna, you started a CRO pre-COVID. Can you walk us through how you think things have changed on the ground?
Joanna Williams:
Oh gosh. Well, I think COVID did change a lot of things and it required us to pivot very quickly to a more distributed workforce, a home-based workforce, which everyone had to do. I think from our perspective in ophthalmology world, I have seen a big shift just in funding, and how sponsors are getting funding, what is being funded. When I first started in this space, it was lots of money being spent on front of the eye, dry eye, corneal diseases, and that has really shifted to more gene therapy, retina diseases, and rare diseases. That has kind of shifted the landscape and the focus of ophthalmology-specific CROs. If you weren’t prepared for being able to handle both sides of the eye, you might’ve been left behind. I think, too, the focus on the sites, the landscape at the sites have changed as well with just consolidation, selling to private equity, or whatever is happening in the site landscape has changed what’s available, who’s available for research. That’s required us to have to think outside the box a bit.
Andrew Pucker, OD, PhD, FAAO:
I think there was a lot of turnover at the sites too for a while, and I’m sure the CRO kind of had to fill in the gaps here and there.
Joanna Williams:
Yeah. I think if as a CRO and sponsor, but particularly as a CRO, if you aren’t focusing on your sites as customers and helping to make their lives easier and executing their trials, they have a choice too. Because that landscape is getting smaller as far as what sites are out there to do research, they have a little bit more leverage over which protocols they choose, who they work with, and making them feel like they’re part of the team, that you’re having consideration for their employees and what they have to do in a day. Is your protocol operational? Is it highly complex? All of those things tie into how well that site performs, how they recruit subjects, how motivated they are to work for that study.
Andrew Pucker, OD, PhD, FAAO:
It kind of sounds like the sites have also found more of their value, or at least they understand their value better.
Nicole Derthick:
I agree with that. The success of a trial depends on the sites. Every single one of them are important. To Joanna’s point, the sites are our customers too. Andrew, you brought up a good point about site turnover. As far as the lessons learned that I was referring back to, it’s critical that you set that study up operationally to ensure the sites are successful even if they do have turnover. What’s in place if your main study coordinator leaves or is out for an extended period of time, we can’t risk study success on those things. It’s critical that you’re thinking about that upfront before you even start.
Andrew Pucker, OD, PhD, FAAO:
Is that how you would say you’d optimize a CRO in ophthalmology? You’re making sure that the sites have backup study coordinators, that sort of thing? How would you define optimized?
Nicole Derthick:
Exactly. That is 1 key area. Yes. We’re natural problem solvers over here. You’re born that way or you’re not. A lot of us have that skill and one of the ways to do that is to set up the sites for success at the beginning. It’s important to us, technology is a big part of our platform. Never stop innovating. That’s how you maintain optimization. You can look to intentionally optimize at a certain point in time, but you’ve got to maintain that, and it has to be live at all points. We’re always actively looking at what’s out there, what’s best for ophthalmology sites. That’s another point too. We’re talking about the difference between ophthalmology versus general, and not every bit of AI technology or technology in general is right for an ophthalmology site or an ophthalmology trial. We’re constantly trying new things and researching what’s out there and always educating ourselves and our team for the best way to deliver every trial individually, what best suits that sponsor, that patient population and that trial design.
Andrew Pucker, OD, PhD, FAAO:
Nicole, do you think in general sites are open to new technology or is it kind of like a mix of people?
Nicole Derthick:
It’s been a mix for a long time. I don’t know if it’ll ever shift and maybe it’ll shift to 60/40 here and there. I don’t know if it’ll ever swing much more than that, but it is very, very much split. When Mintra first started, our mission, we really wanted to engage with the sites and see what they wanted and needed and what they thought and how things should go. That was very much the feedback on the ground from the sites in person is like a split between wanting to go towards the light in technology and wanting to not. We’re happy to figure out a way around it with both.
When you’re looking at trial design and enrollment and patient population, we know which sites can perform well in which area. It’s important that you’re engaging with them early on to see what they are capable of and what they want to do. If it’s a key site for you, you have to adjust your operational plan.
Andrew Pucker, OD, PhD, FAAO:
That makes total sense. Kind of going along with the idea of optimizing, you always have to strike this balance between scientific expertise and operational efficiency. As a scientist, I want to have the most pure study possible with the perfect inclusion-exclusion criteria, but you also have to balance that with operational efficiency. Joanna, how would you go about doing that?
Joanna Williams:
I think that is the most important element of, in particular a specialty CRO, in speaking to specifically in ophthalmology, is you have to have a balance of the science and be able to advise and guide a sponsor on the science element of running this study, but you have to be able to deliver and execute on that study. At the end of the day, we’re all in the data business. We’re trying to deliver data to be used for analysis for an approval for a therapy. Everything else we do is a means to that end.
It starts with that protocol development. I’ve seen so many times where it’s a Christmas tree that just falls over. It’s too many things are added on and they want to explore all these different things or they have all these ideas and it’s scientifically beautiful, but we can’t execute it at the site with the patient. It’s either too hard on the patient, too many assessments, they’re there too long, a plethora of things. I think finding that partner who can help you strike that balance and listening to them.
That’s another thing is getting the sponsors to listen to the advice that we have from all the years of experience of what we’ve seen work and fail, so that we can help them strike that balance between the science and the actual project delivery and the data delivery at the end of the day, because we can do all of that and we don’t have the data they need at the end and then it’s for nothing.
Andrew Pucker, OD, PhD, FAAO:
I love that Christmas tree analogy. Growing up we had a cat and Christmas Eve, the cat jumped on the tree and pulled it down, like everything went everywhere and it was such a mess. Some ideas like sound great initially. Like the cat’s like, “I’m going to go sit on the tree. It sounds like a great idea.” Then it just comes crashing down. We at the CRO need to make sure that we prevent the cat by putting up like a little gate.
Joanna Williams:
Yeah. That’s the risk. I think if you have a highly specialized therapeutic area such as ophthalmology and you go to a generalist CRO, without bridging the gap of the therapeutic area knowledge, you can get something that seems sound on paper, but because you don’t have the experts who have been at the site, who have done the assessments, who understand how all these things are related, what you can do in order. If you’ve dilated the eyes, now you can’t do this, or all of these minor details that all add up to how this study is going to be executed. It’s not to say that big CROs aren’t the right answer. I think in a lot of cases they are. They need to be global, they need to be large, they need to have the scale, but you do need to bridge the gap between the lack of ophthalmology, deep ophthalmology expertise and find that sweet spot to bring both together.
Andrew Pucker, OD, PhD, FAAO:
Nicole, there’s several different ophthalmology CROs in the space and then there’s also bigger CROs that do everything. How would you place yourself in the market to be competitive?
Nicole Derthick:
I think CROs differentiate themselves in a couple ways. At Mintra with our team, we do that through customer service and quality and delivery. At any place I’ve ever been, those have always been key pillars of what my mission is on any given day. We are servant-minded over here. We are here to help those sponsors reach a successful outcome and that’s it. How we go about that, it all goes down into the detail, the quality in our delivery and that’s in each functional area. We are very particular about who we bring on board and that’s for a reason. We have a solid team here. We rely on each other in both the quality and delivery and the customer service area. We’re here, our leadership team is available at any hour, we’re here to support the sponsors and the sites. We’re here to do retraining to answer questions. We’re here for folks that maybe we’re not working with just yet, but just want to have a conversation on planning for next year. We love to do that.
I think those are the 2 main areas where Mintra really dedicates its passion is into the customer service and quality and delivery.
Andrew Pucker, OD, PhD, FAAO:
Customer service is key. Yeah, quality is key. What do you think are some pitfalls that ophthalmology trials run into? Where does quality fail? Maybe for example, some employees at some companies don’t understand the 2-eye issue; what do you think are pitfalls?
Nicole Derthick:
Yes, absolutely. I think the consistency in grading endpoints and reducing variability is a big one. We see that a lot across the board and we are here to stop it. We are here to train. We do have our eye on it and to prevent issues down the road. I can see that if that’s not something that you’re used to looking at or recognizing mistakes in, that that could easily slip past. That significantly changes how your stats analysis and number of patients and what that looks like and really overall success. I think that’s a big one for us. Any others you can think of, Joanna?
Joanna Williams:
I think that the imaging is a challenge just generally. The clinical trials for ophthalmology, especially back of the eye, but also front of the eye are very image heavy and ensuring that we’ve helped to reduce variability in those images and what’s being assessed, whether it’s the actual machine at site, the operator using the machine. Are we uploading? Are we using the same equipment? How is that image being assessed and read and measured? All of those things I think add a layer of complexity and challenge that have to be carefully addressed and to make sure that one; you’re balancing not having overkill because it can be very, very expensive to make sure every site has the exact same OCT machine, for example, and making sure that between that and what is really necessary from a cost perspective and what will affect the outcomes. That’s another area that I think is very susceptible to data quality issues and operational challenges.
Andrew Pucker, OD, PhD, FAAO:
Yeah. You need to have true experts looking at those images too because your just general physician may not have even really had much ophthalmology training, so you want to have an expert in that field. One other thing I think that’s really important for optimizing a study is timelines. I didn’t realize how important timelines were till I came to the CRO space. One man I spoke to once said his payroll at his company was something like a million dollars a month and every month extra that the study takes, that’s an extra million dollars he has to build into his budget. Nicole, how do you try to optimize study startup timelines and timelines in general?
Nicole Derthick:
Absolutely. That is key. Since I first started in the clinical research space, I asked one of executive leadership, what are the most important things? She immediately said, “Time, cost, quality.” I’ve never stopped hearing her voice say that in every situation. I recognize that those are generally throughout the life of any of these trials going to be the primary motivators: time, cost, quality.
As far as study startup timelines go, I mean, our team is so experienced, so that’s great. But what happens if you have someone new? We’re always open to adding new folks in, and what if they don’t have the same experience? We set up our processes in the background just to alleviate any unnecessary administrative burden. We also utilize AI startup teammates so they can automate 30% to 40% of the administrative burden on our folks during the startup process.
I think having the longstanding relationships with the sites, knowing them personally and the coordinators who are working with us during startup, we already know what language they need to change in the contract, or we already have their CDA, or we already have their financial disclosure, things like that that we can just keep track of so we don’t have to ask for it so many times and they don’t have to waste time filling it out. Then working through a bolus of sites at a time, we’re able to do it pretty quickly because we’ve done it so much, but just keeping them all on pace together, it allows us to do startup pretty quickly.
I was at the bigger CROs, the timelines are the timelines. I say they roughly give around 3 months for startup, which is normal, that may have changed here in the last couple years. But when you move over to a smaller ophthalmology CRO, they can actually get started out much quicker. I think it’s because of all of the hands-on customer service that we’re doing with the sites. We can get quite a few sites started up in a month and that was unheard of to me before I moved over to the small ophthalmology space. I just think, in general, the way that we work together and partner with the sites allows us to optimize and streamline that study startup timeline.
Andrew Pucker, OD, PhD, FAAO:
It sounds like timelines are definitely a key metric in these trials. Joanna, what other kind of metrics would you use to judge performance of a CRO?
Joanna Williams:
Yeah, I think data quality is the key metric at the end of the day, is ensuring we have got clean data. I think also almost everything as a CRO comes down to those, like Nicole said, time, cost, and quality, those are the three main metrics that we are judged and held accountable to by our sponsors. I think I always like to also track and measure customer satisfaction and employee satisfaction, and making sure that we’ve got a culture that employees want to work and they’re happy and they’re taken care of and then they take care of their customers. I know that’s not necessarily a metric that sponsors are asking us for, but that is something that we really keep close eye on.
I would say too on the timeline topic, in addition to startup, recruitment is a huge driver of timelines and patient recruitment. Historically, we’ve seen, I kind of keep hammering this, but our tie to how the sites work with us, how we work with the sites as customers and trying to make things easy on them also helps in recruitment timelines and getting patients recruited on time and the recruitment strategies.
Andrew Pucker, OD, PhD, FAAO:
With that, we’ve kind of talked a little bit about AI today already. How do you think, Nicole, AI will play into timelines and efficiencies at the CRO level?
Nicole Derthick:
Absolutely. I mentioned it briefly earlier, but well, actually I’ve mentioned it a few times. It goes along with the innovation path as well, right? We have, since our inception, have been closely tied with a partner in the AI landscape and we’ve been able to test and pilot and build and develop together and we’ve developed these tools centered around the CRO model, and that has allowed us to build and utilize an AI teammate for the TMF. The AI teammate scans, files, reviews all documents and sends them over back to our team for review and finalization. That alleviates a ton of administrative burden on the TMF side.
Similarly, we have the AI startup teammate that I mentioned and that teammate will help our team support through the startup process, freeing up more of our time to focus on the hands-on work with the sites and the questions and issues and challenging situations that arise versus the very common usual fill-in-the-document startup packet. We’re able to automate a lot of that.
It saves time and it also is an extra quality check. Humans miss things, that’s a fact. The AI teammates also run a quality check on all of the documents that we place in there and review with the site to ensure that we haven’t missed a signature, misdated, mistitled or anything like that, so we can feel confident in everything being audit ready at all times.
Andrew Pucker, OD, PhD, FAAO:
I think one of the hot topics right now is new endpoints in ophthalmology and I’m sure other indications too. Joanna, I think you’ve had some past experience at a previous job developing endpoints with AI technology.
Joanna Williams:
Yeah, I think this is a huge opportunity where AI can make a huge impact and particularly in ophthalmology. Historically, the FDA has been relying heavily on visual acuity as an endpoint and it is a direct measure of patient’s function, but we’re trying to prevent the loss of visual acuity, and oftentimes there’s structural changes in the eye that happen years before the visual acuity starts to decline. AI has the capability of trying to help us find the relationships between those structural changes and the loss of function well before it happens. That’s our goal here is to prevent blindness ultimately. I think AI can review millions of images and help us to find those correlations so that we can link that structural change to that clinical outcomes and get the FDA on board as using those as endpoints. I think ultimately, we can cure some of these reasons for blindness and prevent blindness. That’s what we’re all here to do.
I mean, that is what is exciting about being in this space is seeing real life changing therapies happening. We’re working on studies that we’re seeing people that could not see, be able to see. It’s just amazing and it’s motivating and it’s why when I started in ophthalmology in 2011 and I haven’t wanted to leave. I’m most excited about that application for AI. I know there are a lot of people working on this and I’m excited to see where it goes and hopefully we can see some quick progress in that area and start to see those new endpoints being part of studies.
Andrew Pucker, OD, PhD, FAAO:
I think ophthalmology’s really well positioned to be innovative. Joanna, you kind of alluded to gene therapy. When I was a professor at the University of Alabama at Birmingham, I taught gene therapy, a very small part of a course on that. When I first started teaching it, there were no approved therapies at all in gene therapy. Then an eye condition got the first approval for gene therapy and it’s just kind of exploded from there. Now people can go from basically no vision to not normal life, but a much more rich life probably than they had. We’re starting to run out of time here, so I just got a couple of quick last questions. Nicole, if you had some advice for other CROs, your competitors, what would you think makes a true strategic partner in the ophthalmology CRO space?
Nicole Derthick:
Sure. Well, I will say that at Mintra and any team that I’ve ever led, we walk into the situation with a partner mindset and we never step out of that. We are here, as I mentioned, to serve, we’re here to help and guide and be there.
For the sponsor side, I think it’s critical that they inform us of what’s most important to them and keep us along on that journey with them. We want to help, we want to support, we want to set you up for success. We want to give you whatever presentation or data that you need for whatever meeting that you’re walking into. We want to highlight What’s important to you in that delivery of information. It’s important that we know what your main goals are and what your board is looking for and when you need to report things up and out.
I think that’s it, just communication and transparency on your goals and what’s most important.
Andrew Pucker, OD, PhD, FAAO:
Joanna, what excites you most about clinical research right now?
Joanna Williams:
Okay. I think I’m most excited, I’ve already mentioned, through the potential for moving these therapies to market much faster, utilizing AI, really being able to cure and prevent life altering blindness and other diseases in ophthalmology by optimizing technology. I think that’s the most exciting piece right now for me.
Andrew Pucker, OD, PhD, FAAO:
Awesome. With that, I’d like to thank our guests, Nicole and Joanna, for joining us on the podcast today.
Nicole Derthick:
Thank you so much, Andrew, for having us.
Joanna Williams:
Thank you, Andrew.
Andrew Pucker, OD, PhD, FAAO:
Awesome. I’d also like to thank you for joining us today on Clinical Trials Spotlight. If you enjoyed today’s episode, be sure to subscribe and share the podcast with colleagues and others passionate about advancing ophthalmology research and patient care. Thanks again for listening. We’ll see you next time.
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