Alright. Let us begin. Welcome, everybody. Really exciting today to have an awesome guest. Before we jump into the introductions, to make sure everyone’s in the right place, today, we’re talking about boots in the mud, eyes on clean data, twenty five years of cattle field studies. I’m very excited about this one. Many of you know livestock research is something that doing a lot of research into, and, it’s become a big priority for us in twenty twenty six. So I’m really excited to talk to my friend and someone who has, more experience than most people I know. Real quick, don’t forget to sign up for our newsletter where we share, the latest news. We we aggregate lots of data from the web, but, also, we’re gonna be starting to produce a lot more original content as well. Housekeeping items. Many of you have been been through this before, but if you haven’t, if you have any questions, I would strongly encourage you to write them in the chat, and we will make sure to, address all of them. 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We’re really excited about this. We’re putting a lot of energy into it. We wanna make sure that the data is high quality and that, it really gives the industry a good perspective of the state of affairs. Alright. Without further ado, allow me to introduce my friend, Jonalee Meyer-Watkins. Jonalee has spent twenty five years in animal health field studies beginning at Pfizer Animal Health and later spending fifteen years with Midwest Veterinary Services where she led clinical monitoring and helped ensure the quality of data collected in the field. She’s worked across both food and companion animal studies from cattle and swine to companion animals. And what makes Jonalee especially interesting for today’s conversation is that she also lives this industry from the producer side. She markets cattle through superior livestock and ranches with her family in Southwest Montana. She holds a master’s in reproductive physiology from Texas A and M. With that, welcome, Jonalee. Thank you. It’s great to be here. It’s great to have you. Alright, Jonalee. We’re gonna get this one out of the way because I know everyone came here for this question. But please tell us, is living on a ranch anything like the TV show Yellowstone? No. And as I tell, several vet clinics, if if I owned a helicopter, I wouldn’t be here. But you could stay there and then just helicopter places and then come back. Right? That’s true. That’s true. It would make, you know, some of the aviation and and TSA lines a lot easier to stomach. Yeah. So so people aren’t coming to steal your land on a weekly basis? No. No, sir. They’re not. You don’t have any bulls or, like, rip running around beating everybody up? Nope. Nope. Alright. We’re pretty civilized yet. Alright. I wouldn’t be surprised if we see a bunch of these participants drop now that we got that out of the way. Alright. Well, tell us tell us about yourself, Jonalee. Tell us, you know, where you grew up and how you got to where you are today. K. Grew up in an agricultural community north of Sheridan, Wyoming, and we always had cattle and horses. My dad, actually raised and trained running quarter horses in New Mexico and during my growing up years, made leather tack for race horses. And then we had a small cattle herd that would kinda grow and and expand and then come back down depending on our leases for the year. So so I grew up in horses and cattle. I’ve been I think I started wrestling calves at Branding’s when I was seven years old. I think that’s when I wrestled my first calf on my own. It was a baby. I think. Still still involved in, you know, helping with vaccine programs and, you know, deciding, you know, herd health management and also breeding programs. I got my masters at Texas a and m in reproductive physiology, and I was I was very blessed to do all my master’s research in the CIDR insert. So I actually had a hand in some of the synchronization programs that that we use today throughout our industry for both artificial insemination and embryo transfer and things like that. Way back when before it became Zoetis, Pfizer, we were Pfizer Animal Health, and they grabbed me up coming out of Texas a and m out of my master’s program. And I didn’t realize it at the time, but a lot of my background that I grew up in, I was able to apply even then to to the protocols and working with feedlots and dairies and things like that. Because a producer is a producer, and you do have to come at things with their perspective in mind. Even if it’s a research based organization, they still have to procure cattle and things like that from you know, whether it be local sale barns or wherever they’re they’re getting them from. So so there’s a mix in there. Okay. And tell us about, you know, your first real job after graduation. What was that like? What was the day to day like? And did you have sort of a, like, welcome to the industry moment? They always ask these professional athletes, you know, if you had, like, a welcome to the league moment where they got kinda humbled in some way or some crazy thing happened to them. Yes. So in in industry, we work through VICH, which is veterinary international harmonization for the EU, the US, and Japan. And so to get products on the market, we have to run studies. At that point in time, they’re called clinical efficacy studies to those standards. In addition, there’s a whole package that goes into CVM that looks at environmental conditions, manufacturing, and several other items. So I was literally just a small chunk in that clinical efficacy package. And so so the breadth of the programs and why it takes five to ten years to actually get a molecule or a product on the market makes a lot more sense once you’re, like, entrenched in that. So So the the nimbleness of day to day ranching is not present in clinical research. Okay. What what, so let let’s talk about the contrast between companion animal and and livestock animal research. Like, what obviously, different environment, etcetera. But when for the folks that maybe haven’t been quite as involved in the livestock side, paint us a picture. How do those differ? What are the major kind of unique challenges to livestock? How would you kind of characterize those two? So and coming at it from a monitoring perspective, which is which is the where I’ve been the majority of my career, companion animals are very good about eight to five Monday through Friday, and they can fit the dog or the cat in within those time parameters. If they’re an ER clinic, obviously, they will bring the dog in, say, if if something tragic happens and they need, you know, immediate medical attention, or else the owner of that animal will take it to an ER clinic. And then we later come in and gather those records and things and get what we need put into whatever data system we’re working in. With with cattle and and horses, one of the best things to know is, one, they don’t read the protocol. Two, they don’t read a calendar. And three, they really don’t care what time it is. So if you’re running a BRD study, you can you can have animals get sick all at once depending on how high of risk a calf it is that you’re pulling into that study, and you can get into a randomization very deeply, very quickly on on any given day. There there was a joke with within us monitors that there are times that animals just refuse. And so when you’re trying to pull calves out of pens, it may take longer than what because you don’t wanna stress an already sick animal, and they may or may not wanna come out of the pen. You can have calves arrive at one AM into your feed yard, and that’s you know, all of that all of those items have to get processed or, you know, there’s somebody on call at one AM receiving those animals and making sure they get off the truck and into and into the pens. So so, like, the cattle, you can get calls at one PM on a Sunday. You can wake up to a string of text messages at six AM on Tuesday. That that would be one of the main the main differences between the two. The unpredictability of timing, of enrollment, of data collection. Oh, I will say, you mentioned that sometimes a sick horse or a sick animal, it’s hard to get them in. But I’ve tried to take my cat to the vet once, and I imagine it was somewhat similar to that experience. I made the mistake of not bringing it in one of those little carriers, and so I was literally holding it. And as soon as we got in there, it just started crushing me with these nails. They people came rushed over. We’re like, here. Put the what are you doing? Put the animal on this thing. Yes. Yes. I can imagine. It was something like that. Okay. So they’re they’re kinda key milestones in in a animal health study. You know? Recruitment’s a big deal. On the companion side, you don’t I mean, I guess if you’re in a lab and you have lab, you know, companion animals, fine. But if it’s a field study, you you have to go find them, and you find them through sites. You have to find the site who then helps you find the animals that pertain to their site. How does that experience exist on the livestock side? Because these are all kind of owned by the site itself. So how how does patient how does recruitment look on a on a livestock study? So there are specific contract research organizations that have, like, contract feedlots that they do specific research at those at those lots, and they and they limit it to those lots. And and those names are are known throughout the industry. There’s there’s a group up in Canada that does a lot of work. Obviously, MVS does a lot of work. There’s a gentleman out in California that’s just known for for the work that they put together. When we go into into dairy trials, if you’re brand new into dairies, there’s something called the Freedom of Information Act. And if you go to an INAD of, say, an already approved product and you’re looking specifically for dairies, you can go pull up that INAD off of the government, the CVM website, and it gives you the list of who did those trials in the dairy industry and in the horse industry. So a lot of times, freshly new sponsors will go to those those lists and poll and then recontact the same investigators to see if they’re interested in continuing to do studies or if they have the time to do them. And do most people use the same locations, or are there ever how how would a do news new feedlots or new folks get into the CRO business often and, or do most, yeah, if if you were gonna go try and convince, you know, your local feedlot down the street, does that ever happen, or you’d always just kind of say, alright. We’re we’re we’re just going straight to people that have done this before? It it goes both ways. If we do need more sites, they’ll they’ll come to to folks like me and say, okay. Who do you know in the industry? Do you have anybody local? I have done equine studies out of my area, and I pulled on all local producers for that. And in that case, like, you sit down with the local veterinarian, the one that that is contracted for the work on the local feedlot, and, you know, we’ll go through his clientele list or her clientele list. And, you know, there’s usually a certain parameters that we go by. So, like, for the equine studies, they needed to have a minimum of, I believe, twenty head. So we’ve got dude ranches in this area, so we approached the dude ranches. There were there are several working ranches in my area that are quite large that still run a band of horses. So we knew who they were, and we approached them to to do the study as well. So it’s it’s the parameters of the study. You know? Do you need a pregnant mare? Do you need a calf that’s susceptible to BRD? And then you you go through your list from there and approach them after that. Okay. And is it typically what’s the success rate of of when you talk to one of these new researchers that are that you’re trying to convince? Do they often balk at the idea of being involved in these studies, or do a lot of them most of them say, yes. We’ll do it. How does, you know, how does that typically play out? I’m gonna say my success rate has been about seventy five, twenty five. Oh, wow. So That’s probably higher than companion, I imagine. I mean, there are people that have booths for the sole purpose of recruiting clinical sites and veterinarians to be involved in the companion side. Yes. But at the same time, like like, we have to go in and, you know, you have to be very forthright with the time commitment. You have to know that they either already have the employees and they can pull an employee to come in and do this work. Even in a swine study, you know, like like a junior office manager or somebody, and they can say, okay. You know, I can dedicate said person to these tasks. So so you do have to be forthright with the time commitment. You need to make sure that they already have the employee staff to do it, or else they’re willing to find the employee staff. And and then also, like, when when I’ve sourced animals for studies, like, we have to be very forthright about the final disposition of those animals. Some of them go on to be fed and and and slaughtered. Some some stay in programs. But, you know, if it’s a terminal study that sometimes happen, you know, for for, like, the target animal safety, you have to be very forthright. So and probably the main thing on the employee side is if somebody doesn’t have the staff, but they’re willing to hire, we’ve been able to pull sites in because the sponsor is willing to help pay part of that employees or that new employee’s salary. So it makes it more palatable and easier for the newer sites and the newer producers to do this. I think probably one of the most important key things for any sponsor to understand and whether that’s the person cold calling them or not is that these guys aren’t necessarily looking for more work. Our job is to go in and put that study into their daily life, but to also make sure that their current way of doing things will allow the study to come in and work in daily life. I hope my team’s listening to that because you just basically articulated the the the real challenge of even technology adoption. Just gotta fit right into what they’re doing. And if it’s a major new workflow, forget it. Okay. Talk to me about monitoring. What does monitoring look like in a livestock study? How what’s the day to day there? So, it was actually one of my more favorite parts in the beginning of my of my career because, I got to leave the home office and actually go to the feedlot, go to the dairies. I got to to to love on animals again or at least see them. So as a monitor in an FDA study, you’re actually not allowed to to handle the animals. You’re you’re not allowed to enter data. You’re there to observe to make sure that everybody is doing things per the protocol. And so this this comes back to the does this work into your daily life? Now if it’s an actual CRO who they’re used to doing the BRD or the feedlot studies, they know what to do. If it’s, say, one of the newer producers or newer feedlot, you’re there to help coach and mentor them as they work through the animals and the protocol itself. So I’m gonna say, let’s just take a BRD study as an example. On when they pull them from the pen because they’re exhibiting signs of lethargy, their their head is down. If it happens to be slightly snowing that day and you can see a calf that the snow is just melting on its back whereas other calves have snow on their back, you’re probably gonna pull that calf. There’s a chance that calf has a fever. And so you’re gonna walk through things with the pen riders. Like like, you’ll stay up on the fence with them. And if they have questions about how they’re filling something out, you’ll help answer those questions. You’ll follow the animals through to the pen and then chute side. You’re looking at the veterinarian as they perform the physical exam, taking the body temperature, who’s entering that data, and just ensuring that, like, not only the flow, but but that GCP standards and protocol standards are being maintained. And are you mainly doing that, like, the first week until they get the hang of things, or do you have to be there for the whole study? Usually, the first few days, and then they and then they get the hang of it. And then how do ensure that they that that training’s stuck and they’re actually staying compliant? I guess you get the paper forms back, and you can see, like Yes. Oh, hey. This this data looks weird. Yes. And then, of course, with EDC, you can you can log in the next day and make sure that things are still are still getting getting put in as you would expect them to. That real time monitoring. Yes. Okay. We have our first question from an audience member. By the way, I misspoke. I said chat. It’s just the q and a button that you would use to ask a question. So first question from the audience. Is your experience that livestock animal providers are often unaware of just how much of a time commitment the research trial is? They may agree and be on board initially, but aren’t fully immersed in just how much of a commitment it is. Then you get partial protocol compliance, for example. Yes. So that’s a very fair question. And it’s something that that, like, you really, really have to drive home with them. Where I have been successful is the or I don’t know if I should even say successful. Where it has worked for me is I worked very closely with my veterinarian that is over that that site or or that farm, and and they are very aware of the time commitments. And so I’ll set up things from them upfront. Like, if it’s if it’s a day where we’re gonna go and do physical exams and determine eligibility for the study, like, let’s just take a horse vaccine study as an example, I tell them to block off six hours. We’ve got we’ve got the travel time. You’ve got the time with the animals. You need to take the time with those that are that are pulling the horses in and doing things for you. And so, like like, I lay out timelines for them beforehand. And a lot of times, timelines are tied to compensation. So when they understand that, you know, every time we go out to do observations or perform injections or whatever the topic of, you know, the the study schedule lays out and they know that it’s gonna be a six hours out of their time, they lay out their budget because they know what they need to be compensated for. Because when they’re out on that farm and along with the owners and and the help, when they know that they’ve got six hours of their day already being taken up by something else, They know what they need to be compensated for that time period, and that’s how I’ve worked around that. Are there common challenges let’s say I’m I’m trying to get in the game. I’m trying to get in the business. I got a new product. I’m gonna run my first livestock study. Are there common challenges that you see in these livestock studies? Like, the what are the biggest common challenges that you you think? Is it training these folks? Is it ensuring compliance? Is it data management? Something else. I would say one of the one of the bigger challenges looking at it from a new producer standpoint is to ensure that they give you the right kind of animal. So if it’s a BRD study, you need to ensure that they’re sourcing high risk calves, calves that are gonna get sick. If it’s if it’s a horse study, the say, an equine respiratory disease study, are you going to a CRO or a veterinary clinic that that sees a lot of equine respiratory disease, that sort of a thing? As long as I haven’t really had issues with compliance except for maybe, like like, the techs that don’t quite understand or if a tech has been forced into doing something by their veterinarian, that’s where I’ve had compliance issues. I’ve never had a veterinarian look at me and say, never mind. I don’t wanna do it. So I’m very thankful for that. Talk to me about that vet tech dynamic. Like, how do you know if the techs are onboard or not? When you’ve been in it for a while, you can usually tell when your first time on-site whether or not a a technician really wants to do it. They give you, like, mean looks or something or, like, their heads are down while you’re while the boss is telling them they’re gonna do it. Yeah. They’re they’re just not engaged. And when they’re not engaged, I mean, I’ll I’ll not only I’ve called those techs out and been like, hey. Are we okay? Hey, you. I know you’re not feeling this. Tell me. Why aren’t you feeling this? You you have to because that that data ultimately affects the entire course of the study. And then I’ve also visited with the veterinarians that have you know, and have said, okay. Are you are you sure this is who you want on the study? Or if this is your person, what can we do to help ensure them that that we’re not just gonna work them into the ground. And Yeah. And at that point in time, it becomes a veterinarian, you know, technician relationship. And and sometimes you do have to hope for the best because sometimes it does not go well. Do you have any sort of, like, strategy for getting techs on board? Like, what it what what messaging or how how do you get the techs to to wanna be involved or to not push back? So so compensation always helps. Right. And then and then also, like, an acknowledgment, whether you’re in a companion animal clinic or or mainly food animal clinic, an acknowledgment of what they do every day. Like, there’s no they’re not sitting at the desks with their feet up eating bonbons. Right? Like Yeah. They’re they’re they’re taking temperatures. They’re inventorying vaccine and other and, you know, other supplies. They’re they’re getting yelled at because they’re not moving fast enough potentially. So a general gratefulness and thankfulness and respect of who they are and what they do on a daily basis is is a tremendous help. And I would also say that for your veterinarians. Like like, since twenty twenty, the the suicide rate of veterinarians has has gone up significantly. The the social media has been both good and bad as far as, like, how it can exploit what may look like a veterinarian being hard on an animal when actually the veterinarian was just protecting him or herself. And so I think a general acknowledgment within our industry that says, you guys do not have an easy job. You’ve chosen to stick with it, and now we’re asking you to bring another thing onto your plate. That acknowledgment and working with them within that generates a mutual respect between Yeah. Between sponsor and veterinarian, and you you normally get better results. Yeah. Gotcha. Another one from the audience. Do you think that EDC and I didn’t plant this. Do you think that EDC on tablets to collect data makes monitoring more efficient, or might it also bring new challenges such as problems with network connection and data access? Okay. So speaking strictly from a food animal standpoint. So whether I’m in a vaccine study out on a horse farm, whether I’m at a feedlot in the middle of a pen, a dairy barn, which oftentimes doesn’t have great reception, or in the middle of a swine barn, which has zero cell reception, offline data capture is key, period, the end. You have to be able to have forms load, succinctly, especially when you’re working a bunch of animals at once. So the other side of this, you know, especially on the tablets, is they need to be multi animal forms. So not a single form per animal, but something that says animal ID and then whatever you’re observing at that time and be able to have those forms load as they’re working animals so they’re not working, you know, or waiting on the tablet. And then when that tablet goes back into the main office or, you know, to the home, wherever vet clinic, and it gets hooked up to Wi Fi, you can just zoom that data straight up to the cloud. So if you’ve got a good offline data capture system, actually, tablets, I think, make life easier. The main thing would be ensuring they’re charged and ensuring your study personnel plugs them in at night. Yep. I have both of the last two questions. I was visiting a a poultry farm. Okay. And they do a lot of research. And I was doing a walk through, a tour, and a vet a technician was in the room. And as we walked in, the lady whispers to me and says, that guy over there really doesn’t wanna use EDC at all. And, so we’re walking through, and, you know, I could tell he wasn’t super excited to see me. And I asked him, hey. So I hear, you know, how’s it going? I hear, you know, might have some struggles with the EDC. And I think I think it was very brief. And he said, I don’t want anything to do with that technology, and then, like, walked away. That was it. I was like, okay. Well so so both your story on the on the technician experience and the EDC adoption kind of applied there. Yep. How do you let’s talk about technology. How do you make the case to these folks who especially the technicians who basically are in sort of a I mean, time to data entry is so critical. These these people are efficient, running through with paper, just going up and down either aisles or getting animals in and out and collecting that data really, really fast. Sometimes it is hard for, you know, a tablet to beat a piece of paper. Yes. You can get certain repeated data, automatically populating across forms, but some people push back on that data entry piece. Have you found that to be a challenge when when trying to introduce technology to a study? And what other challenges have you seen? And then how how, you know, how would you speak to that, and how would you convince them that it’s still worth it? So depending on the study, and I’m thinking of, like, a large scale swine study, the amount of paper that they have to carry with them, especially if you’re especially if you’re working piglets. So, like, in a farrowing barn and minimum eight piglets per sow. And and you’re taking body weights and maybe giving, you know, that that first iodine injection injection and potentially what whatever else the farm SOPs require to do that all on paper and to keep track of that paper without a sow eating it, which I have had. I actually had a colt one time, horse horse baby eat some data. I I I wasn’t paying attention. He was like, oh, look. Look at this clipboard. But but, anyways, keeping track of that data can can be difficult. And so it’s a lot easier to just have a tablet in front of you and then have the data have the paper data as a backup. The the the key to that is they have to understand that, like, if they do fill out a paper form, it does have to be transcribed back into EDC. Yeah. Ultimately, it causes them more work. Yep. Yep. The whole picture, you’ll save time, but maybe not just in that isolated data entry piece. Yes. And and the flip side of that also with the paperwork is that, like, to maintain GCP standards, it has to be attributable. It needs to be legible. It it needs to be accurate, contemporaneous, the original collection. So what that means on a piece of paper is dating it uniformly across every single sheet of paper, initialing or signing and dating it, and doing it as real time as possible. Whereas when you’re in EDC, the date, the time, the the accuracy, most of the time, is is taken care of in the background automatically. So you’re not signing your name twenty times in one day. It’s the the audit trail automatically takes care of that for you. So it it ultimately saves you time because of what’s already logged in on the backside of that EDC that that the technicians don’t see or, you know, or even that the veterinarians don’t see until you point it out to them. Yeah. Alright. We got three in a row from the audience. First, how do you address issues that are really challenging but don’t appear or sound like they should be? For instance, stakeholder leadership may be somewhat surprised to discover that smaller livestock production, like swine and and smaller, is really hard to count correctly, and this has major implications for clean data from the study. So you are correct. Especially piglets, they multiply without knowing, or they slip between and and they and they cheer mamas sometimes. That also happens. So what I did on on a recent equine study that with brand new it was a brand new clinic, brand new clients, the whole nine yards. There were several times that I just looked at them, and I said, I know this does not make sense. I know that this does not make sense in real life what I’m asking you to do. But at this moment, we’re not in real life. We’re in FDA land. We’re in CVM land, and this is why we have to do it this way. Because if I can’t reconcile these numbers or I can’t reconcile this this page of data to that page of data, you just did all this work and nullified this entire case. I I have yet to have a veterinarian push back on me or a technician pick push back on me when I’ve explained it in that manner. They have rolled their eyes and said, are you kidding me? And I’m like, I’m sorry. You know, this is how CVM works, and this is this is what you as a clinic signed up for. But once you can tie it back to what we’re tied to, it does help them understand the tidiness of of some of the things we’re asking them to do. Yep. Okay. Next one. What are the best practices for monitoring a long duration livestock study with numerous follow-up visits and assessments over time? Consistency, and that means writing down decisions from the beginning. So if it’s I’ll I’ll choose a Fidom and William study as an example or something. There’s a problem that you encounter at a site at the beginning of the study, say say an implant doesn’t go in quite right, however you choose to handle it on that very first animal needs to be implemented across all your sites. So so you have to keep the FAQ list going. Spreadsheets and tracking are obviously very, very helpful. And then this is where I would say, internally, knowing that the the project manager is extremely well informed of things that are happening at the site as quickly as possible, especially if there especially if there’s an issue. Also, when I was on a longer livestock study, we did prefill our our visits for a year. Like, we were like, we were out there every two months. It just it just was what it was. And we made sure that the sites knew that we would be out there so long. I does that does that help? Did I answer that thoroughly enough? Okay. Yep. Another one. Is it even possible to get contemporaneous data during offline data capture? So with the systems that I have used, which includes Prelude, and this is not an advertisement for Prelude for offline data capture. It is because the tablet is in front of you. And as the veterinarian is examining that animal, we’ll just take a physical exam as an example. And you’ve got the technician entering the data on behalf of the veterinarian. So he’s going down the systems, you know, integumentary, eyes, ears, that that sort of a thing. And they’re they’re hitting either normal, normal, normal, or abnormal, say you get to the respiratory system, and then they have to type in the comments of whatever that veterinarian is saying. So it is contemporaneous, and then this is where Tommy will have to jump in. If I remember correctly, the audit trail is still in working during that time. Yep. It tracks both the data entry time and the data sync time. Yes. So then when it goes back on to to your main office and hooks back up with the Wi Fi and everything uploads to the cloud, all of that data is there, and so, therefore, it still is contemporaneous. Yep. How do you overcome the language barrier with a tablet versus paper? Okay. So it’s probably speaking of of Spanish Spanish speaking individuals as their native language. We have had interpreters at sites before for swine studies. So, like, the lead the lead farm manager is usually is usual will leave bilingual, and they will help whoever is entering the data. A lot of times, even if Spanish is their first language speaking, they can normally read English, and we do keep the forms more simple there as well. Way back when gosh. This was a long time ago. We actually tried to translate paper data capture forms for Spanish speaking individuals for a dairy study, and it actually didn’t work because CVM said there was too much difference between the the different kind of oh, what’s the word? Within within the Spanish language, there’s there’s different offshoots, and so they didn’t want that to be confusing. And so CVM actually didn’t accept our bilingual forms, and we hadn’t started the study yet. But we had approached CVM about it, And they said they said no to bilingual forms. So most of the time, the Spanish speaking individuals can read English, and then we have an interpreter as far as, like, the the main farm manager, at least at swine farms we did, and sometimes in the feedlots with our pen riders. Well, that’s useful. Okay. One more from the audience. Can the study protocol contribute to the success of a livestock clinical study in terms of data quality and the reduction of missing data? To what extent does a well designed protocol improve data completeness, consistency, and overall study outcomes? I absolutely. One thousand and ten percent. Yes. You you need a study protocol that takes into account, and this is where I would say, go to, like, the MVSs of the world or the company in in Canada that they have not only managed feed yards, but they’ve also run studies in feed yards. And have them take a look at your protocol and give input because your your protocol and your forms drive your data. So it’s worth the time and the efforts and sometimes the absolute tediousness and pain of going back and redoing the protocol a couple of times in order to get what you need. A really good example, I ran a couple of foot rot studies, one with Draxin, another with a with another. And the difference between those two protocols, one of them and this is so cute. They wanted the veterinarian or the technician to measure the steers or the heifer’s foot in the chute and and enter that rather than doing, a a swelling or a heat and evaluating it that way. And we went back to the sponsor, and we said, so these animals are not tame. Chances of them holding still long enough to get an actual measurement of that foot circumference along with keeping their fingers from getting smashed is fairly low. So can you please look at evaluating the foot in this manner? And they did. So, like, those conversations with key opinion leaders are truly, truly worth having. Awesome. Okay. Tell me more about, so there’s a lot of technologies I found as I go to these livestock oriented conferences. RFID tags, feeding systems, a bunch more, how do what role do those play in, if at all, in running sort of regulated studies or nonregulated studies? And how how do you think about that in term versus sort of manual data entry and and the data in the EDC? So I think they can go hand in hand. And, like, I’ll take the RFID tags as an example and just kinda run with that. So there are feed lots currently that for those calves that come in and have the RFID tags in, and they’re coming in on the semi. They have a transponder as they’re coming into the the feedlot, and, obviously, the semi has to slow down. So as as that person slows down, that transponder is reading all the RFID tags and prepopulating a spreadsheet so that when they go to unload and process those calves, they can just cross reference the spreadsheet with the RFID tag and say, yes. This animal is truly here. So it saves you time and effort that way. That would be amazing for marketing studies. So for those studies for those products that are already on the market and and you’re you’re moving with them from there. As far as, like, how they would work with technologies, I think it would have to be a conversation between the sponsor and their EDC company of choice to see if you can get those spreadsheets integrated into the EDC for some sort of prepopulation. And then there would just have to be a record of where that data was transcribed from and how and why. Yeah. Are there when you think about just data management as a whole, are there sort of, you talked about the common issues of getting sites to get on board with the study. Are there common issues that you see in terms of data management for these livestock studies? And what would you say are is the biggest or or or second biggest? Or or in in other words, like, what are some big best practices to use for data management for these studies to overcome these big hurdles? One is the one is the time issue. So if you’re working with a CRO already that that they do research studies, they’ve got the research feedlot, that’s different because they’re that’s what they’re there for. Right? They they know what they’re getting into. If we’re going to to to a larger dairy farm and working with a veterinarian that is managing that dairy farm or the herd health of that dairy farm. And the same could be applied to to other feedlots, horse, etcetera. They have to understand what they’re getting themselves into, and that usually comes along with compensation and, again, a a predetermined time. So I’ll use this last horse study that I was on as an example. By about mid study, they were like, hey. Doing one of these cases and doing you know, answering your questions while the case is ongoing is adding about two hours to my day, and that was probably extreme. But and I and my answer to them was correct. It is. So now you know if you choose to continue in clinical studies, you need to plan for this extra two hours and also ensure that you’re being compensated for this additional two hours. And so when we’re allowed to have those conversations with the site up front, it is very, very helpful, especially if they’re new to clinical studies. It’s funny. As I do more and more learn more and more about how clinical studies are run, so much of it is just site management. Relationship site, communicating properly, getting aligned, just making sure your site management is in place. Yes. And it’s true for especially true for companion. Alright. I got three from the audience, and we’ve got a little less than ten minutes. First one, for clean data, do you have formal data flow specification steps that mark transitions from process to process, also among different professionals, that you you then use to identify specific datasets or steps in your process, perhaps such as raw data generation, data assimilation and calculation, dataset for stats analysis, stats analysis results, dataset used for inference, something like that? If so, what advantage might this approach confer? So the short answer is yes. And it starts at the monitor and the project management level. And we sit and we go through the protocol, and we’re like, here are the hang ups. You know? There’s there’s not a flag on body weight range, and we can’t have animals that weigh over whatever in this study. So so it starts on that level. It starts on the granular level. And then those of us that are monitoring, we know exactly what to look for and where to look for it. And then we’re flagging or querying those things that are out of range and writing deviations. And we’re also visiting with our project manager and the sites at the same time to say, hey. Please watch this in the future, or I need you to look at this again, you know, even if it’s a body temperature on on an animal. And so after you get from the project managers and and the monitoring level, they they have to come back into the sponsor to implement everything else that you just said. But it it starts on the granular level before the study even starts. Like, as we’re preparing for a study, we’re looking at all of those things because you essentially have to reverse engineer. Right? If you want your study file to look like x y z, what do you do from the bottom to get to where you wanna end? Okay. What does a good field site look like beyond the selection criteria listed in the protocol? So this is where we go in, and we need to look at I’ll take a horse study as an example. You know, are the are are the facilities in good working condition? Like, you’re not gonna get scraped up legs or there’s not wires sitting out for somebody to trip on. Do the people that are handling the animals, do they have the experience? And and that’s looking at CVs. That’s visiting with your veterinarian. That’s visiting with the farm owner of of where his where his or her people came from. And then, of course, lastly, you know, are you willing to let us come on and use your facilities and animals? Okay. What would be, like, a gotcha? You know? Like, if or a red flag if you were looking at somebody, you were considering somebody, and you saw this, you’re like, and then we’ll walk away. Or So if there are corrals that are, like, tumbling in on one another, if we’ve got if we’ve got down posts, if if you’ve got facilities that are that aren’t clean. I mean, they’re animals. But but, like, if if you walk in and it’s obvious they have not scraped the pens or scraped the alleyways in six weeks, thank you. A flag years ago that would have been and I don’t I doubt these clinics even still exist now in the companion animal world. But if you walk in and everything is on paper and their filing system has has cards going every which direction, then it’s just it’s not a good idea. Because if they can’t keep their own cards put together, they’re not gonna keep your data put together. Yep. Yep. It’s like hiring a a c or a d student. You know? They’re not gonna take care of the their own homework. What kinda how they’re gonna take care of the homework that you give them when they come work for you? Correct. Okay. What is the lesson you learned from a failed or difficult livestock study that you still apply today? K. I can’t break confidentiality, so I’ve gotta I’ve gotta figure out how to how to state this. Sometimes sponsors bring to you something that isn’t necessarily a need in the market. And you you can tell them that, okay. This this isn’t necessarily, you know, a a strong need or a strong market need. They may or may not believe you, but a lot of times, you won’t get investigators and sites to sign on because they look at it, and they’re like, this is not something that keeps me up at night. The the the flip side of that is if they still and this would be in a different species. If they still choose to proceed with that, the study itself will actually tell them, and that’s when you encourage them to put in an interim analysis so they can see that the product is not working. Makes sense. Alright. Last one, and we’ll get everybody out of here. If you could put anything on a billboard to tell the animal health community about livestock research, what’s the thing you would put on there? You’d want them to know. It’s it’s important to do, and it’s important to keep working, especially when you’re talking about, like, cattle, pigs, poultry, we’re still feeding you. And that’s coming from me as a rancher. Like, my calves ship on October thirteenth. They’re headed to Texas, I believe, to a feedlot. I’m still feeding you. What goes into my animals and how I manage herd health is important because it still affects the end user, and we need to keep eating. Like like, what? Oh, thank you. I don’t know who gave the reaction, but thank you. I that’s something I obviously feel very passionate about, that that what we do matters. Amen. You’re here. And and on both ends. The rancher matters. Animal health matters. Yep. Thank you. Look at all that. Alright, everybody. Please fill up the survey. Let us know how we did. Let us know, what other content you’d like to see. Thank you everybody for joining. A special thank you to Jonalee. I take it if people have follow-up questions or wanna, you know, get in touch, find you on LinkedIn. Thank you. Okay. And, do you have a website for your consulting? I don’t. You can find me on LinkedIn. Okay. Find her on LinkedIn. Alrighty. Thanks, everybody. Have a great week.
