How to Partner with Your CRA for Best Trial Outcomes

Jen Stacy, Director of Clinical Operations at Novotech, shares how building trust and alignment with your CRA from the outset leads to smoother study execution and better results.

With a background as a nurse and site coordinator, Jen brings a site-centric perspective to common challenges like delayed payments, protocol deviations, and data quality concerns. Learn actionable best practices that CROs and sites can implement to strengthen collaboration and ensure compliance across the full trial lifecycle.

Transcript

Jimmy Bechtel: 0:01

Welcome to SCRS talks provided by the Society for Clinical Research Sites. Thank you for joining us as we explore the latest insights, trends, and innovations shaping clinical research today. I'm Jimmy Bechtel, the Chief Site Success Officer with SCRS, and I'm joined by Jen Stacy, the Director of Clinical Operations with Novotech CRO, here to share a little bit of how Novotech approaches their relationships with sites, builds stronger collaboration, and assures that everything we're doing is on behalf of patients. Jen, it's great to have you here with us today. Really excited to jump into this topic and talk in some some general areas about how Novotech approaches your work with the sites. But before we jump into that, I'd love to start us off with a little bit more of an introduction from you.

Jen Stacy: 0:48

Thank you for having me here today, Jimmy. My name is Jen Stacy, Director of Clinical Operations here for Novotech in the US. A little bit about my background. I am a cardiac critical care nurse by training and that was the pathway through which I ended up working in clinical research, am a very strong advocate for patients, and a very strong advocate for those of us working within the research arena. I joined Novotech about a year ago. Novotech has been around for 27 years, had a very strong presence in Asia Pacific, and about 10 years ago decided to become a global CRO with a world class operating structure and presence. And the way they did that was by partnering with existing smaller CROs that they purchased and one of those was here in the US. Since that happened a couple years ago, we have had an incredible amount of growth here in the US and we've seen an incredible amount of growth with Novotech. In my previous job I was director of clinical operations for a partner CRO, and I got to know Novotech and was so impressed with their dedication to quality, and that's what made me want to join the organization. In my background, I have certainly worked with small biotechs and at one point in my career I was the clinical department for a small biotech. There were only 13 of us. We did get our FDA approval for that particular product that we were working on. But it gave me a lot of understanding of how difficult the playing field can be for small biotechs, and that's the market that we cater to. Novotech really works exclusively with biotechs. And that understanding early in my career gave me a lot of sympathy and, understanding of just how challenging it can be. Our clientele do not always have the massive resources you see in Big Pharma. And so we partner with them to come up with better strategies to get your patients to have clean data, to get to that finish line in a streamlined, efficient manner. So very happy to be here with Novotech. Very happy to be here today joining you, Jimmy. Thank you.

Jimmy Bechtel: 3:06

Absolutely. Thank you for the introduction and some of the background on Novotech. I know, given the nature of your business that there's probably a lot of members that haven't yet had the opportunity to be exposed to your operations and your clinical trial execution services. Really awesome to have the opportunity to dive into those today. And speaking to that, we know there's a lot that goes into running an efficient and compliant trial. I wanna start with site payments, which always seems to be a hot topic amongst the sites. It's always kind of the number one or number two challenge at any given day or time. So maybe from your perspective and the perspective of Novotech, what steps can be taken early in the study to ensure that payments are initiated smoothly and these processes and how we get things executed can be improved over time.

Jen Stacy: 3:51

Sure. You're right, that is the hot topic. And there's a number of different things that we can do that we can partner with sites to help create a more efficient process for them. Obviously, the first key step is you've gotta find those patients, right? And that's not always an easy process. That's the first step. You have to have the patients in the enrollment. The next step is submission of data. Many times we'll see that these small biotechs are anxiously awaiting that data to be submitted so that they can do all the pieces that they need to do on the backend. And have interim analysis, do the number of safety steps that they have to do to protect patients. Clean data submitted according to contractual timelines is key. And that includes data, not only data submitted, but that we've closed out queries, that we've done all of those steps to have a really clean database for the site. And this is where I think oftentimes we miss the boat in realizing and I was a study coordinator in my career this is a difficult job. These study coordinators are running to sign consents with patients, they're trying to draw labs, they're answering the phone, they're rescheduling patients. These are very busy people, very professional. They have a lot on their plate. Timelines are not always an easy thing for them to manage And when we know that payments are tied to these sorts of timelines, reaching out early to your CRA, use them as an advocate for you. Often we see that CRAs can help the study coordinator to batch certain critical pieces of data, like go back to the sponsor and work as a liaison for you to say, okay, we need data up to this point and no further. Or let me work with the sponsor to see if we can get some additional help for you or any number of things that sites aren't always aware that that CRA has the ability, the wherewithal and the willingness to assist the sites in getting these pieces pulled together. And then the other thing is know who your CRA is, obviously, and use them to reach out to the CRO. Often what you'll find is, and certainly here at Novotech is that zero if there's a problem where the site is saying, look, we've submitted everything we need to submit. We've done our part that CRA is able to gently and with some finesse, push on your behalf as a site. That is one of the most important things, that we forget to utilize that CRA. They are not there to just walk in and tell you everything you've done wrong. They're there to create an alliance with you and advocate for you. So utilize your CRA and just work early in the process. If you see that you're gonna have some sort of challenge or difficulty with timelines, reach out early and have that discussion because there's usually options that can be created for sites.

Jimmy Bechtel: 6:46

It's a great point Jen, and it's great to hear from the CRO perspective, how important that CRA/ site relationship is and how it's founded in the spirit of collaboration. Because we often see and hear sites tell us, oh, we want to be more collaborative with our CRA, or, we need to be more collaborative with our CRA. But it's great to hear from the CRO perspective that that's how their relationship is built. Foundationally, it's almost a cultural thing to bring in and have team members that help build those relationships more effectively and approach the collaboration in which the spirit is intended for the sake of collaboration. Speaking of collaboration, we know how important that strong collaboration is. I wanna shift gears a little bit and talk about protocol deviations and knowing how those can impact timelines. Maybe share a little bit of some of the more common causes that you're seeing, but also more importantly, how that strong relationship can help prevent or avoid or address quickly when they do happen those deviations.

Jen Stacy: 7:48

Sure. There's a number of things that I see as causative factors for protocol deviations. One of the most common is site staff are, really busy, sometimes understaffed. We have, in many cases, we have what I call the cream of the crop. Our research site staff are the cream of the crop. They are experts in their field and they're not just doing research, they're doing other tasks as well. They're actively seeing patients. They're pulled into process improvement. They're doing so many things within. Their facility besides just the research. So we find they're very busy, sometimes understaffed, and that is sometimes a source of protocol deviations. They just don't have the resourcing they need to cover all of the minutia of protocol compliance. Another thing we see is difficulties when the protocol does not match standard of care. Some of our most cutting edge and exciting protocols are gonna be found in this space, but it's also a challenge to implement those protocols at a site level when they really differ highly from standard of care. And then the third and most common thing we see is lack of patient compliance. Sometimes this is because the patient is just not compliant and sometimes it's a combination of factors. It could be intrinsic health issues for that patient. It could be any number of things, not just that the patient doesn't want to, but the patient is somehow unable to be compliant with the protocol. So those are the most common three reasons that we tend to see protocol deviations.

Jimmy Bechtel: 9:28

Excellent. Thank you for sharing that. It's important, like you had stated to work so closely with your CRA on avoiding those things. Some of them are tough, some of them are really out of the hands of the sites and they happen. And maintaining those strong relationships with your CRA on how to mitigate that or, work quickly to, do what needs to be done to move on, I think is really important. Data quality, we also know is a really common focus area. What strategies do you recommend then to help sites minimize data queries, which could eventually turn it into protocol deviations as they work in their EDCs and how they work with their CRO or partners to manage that and minimize those issues.

Jen Stacy: 10:09

So there's a lot of different creative things that I see happening to improve data quality and to mitigate those protocol deviations. Take for example of wrong informed consent versions being done. That's a protocol deviation. One of the creative things that I've seen recently was a CRA went into a site and there had been difficulty with the site using the wrong ICF. The CRA had built this really collaborative relationship with the site, and she went in and had a pack of yellow paper and a pack of blue paper and said, may I use your copier? She copied the correct versions, version two and version three of the informed consent on different colored papers, and it stopped those protocol deviations because now those busy nurses on the floor would look at the chart and go, oh, I have only the white copy. I still need a yellow and a blue one. And so she pulled that and was able to have the correct versions ready and available, and that protocol deviation went away. Some of the other things we commonly see, for instance, are the wrong lab kit being used. Or MIS labs, sometimes our MIS labs are because the patient is, just a tough stick. We're, having a hard time getting IV access or any kind of access. But sometimes it's because of the time of the labs that we've missed them. Working with your CRA to say, look, I'm supposed to do a lab that's 12 hours after the signing of consent and our site's closed, then what do we do? And come working with them to come up with a plan and wrong lab kits being used again, using little visuals, stickers or something that will kind of give you a cue, but there's also usually all sorts of site specific tips and tricks that your CRA can work with you on to come up with a plan to help you with those. Missed visits, as difficult as that is, and I know this is such a challenge'cause it is outside of your hands in so many cases. But for instance, if you have a study where the patient needs to come in really early in the morning for a pulmonary function test and you live in Minnesota and it's wintertime and you know, the weather is gonna be challenging for this particular patient. We can talk about that ahead of time and see if maybe we need to, have a taxi set up for this particular patient to bring them in so that they're not struggling to drive and get to the site. There's all sorts of options that at least here at Novotech, we're certainly happy to walk through different options with the site and figure out what can we do to help you with these. Then there's other strategies as far as overall data quality to just help minimize like data queries in the EDC system. Often we'll see sites who are running more than one study and they'll have one study coordinator for one study and a different study coordinator for a different study. Having them cross-trained and then able to do a quick QA check for each other on behalf of each other has. That just does wonder. Some of the absolute best sites I've seen in my 25 year career have utilized that sort of QA process with great success. And then the other thing is talking to the CRA to say, Hey if you see trends while you're here on site with us, let's talk about how we're gonna address those early in the site visit. Having that discussion about, I think we're gonna have a lot of missed data points for this particular lab or this particular vital sign, talking to the CRA to say, Hey, if you see any trends, let's talk about how we can do this as a bulk. Let's bulk address it so that we're not issuing hundreds of queries for the same data point. And most CRAs are just absolutely delighted to work with sites to come up with a plan to streamline the process and make it easier. There's all sorts of tips and tricks like that that we can do to make it a little easier and get what we all want, which is quality for these patients and for our data.

Jimmy Bechtel: 14:05

Excellent points. Jen, what I took away from your really great and thorough explanation is collaboration in the form of not being necessarily worried about approaching the tough conversation because some of these things, the sites we know are pretty worried about, or they question how that's ultimately going to affect their relationship long term with the CRO, oh, I did this or I did that and it's gonna do this. Or they're afraid to be seen as the whiner and that they'll never get worked again. But it's great to hear someone in your position, who's overseeing these teams and has an extensive background in here to kind of say it's okay to raise the flag here a little bit and say, Hey, we noticed this in the protocol or in the execution documents that is gonna be a difficult for us or this is gonna cause potential problems. And we know that when things get put into practice is when we really start to see. What potential challenges that are gonna be there be when we go into practice beyond theory when the protocols are written. It's really reinforcing and good to hear that perspective on, those concerns, develop that collaboration with your CRA, the relationship so that we can work through this together because what we're doing here and everyone should be and is concerned with is data quality and it affects everyone in the end. The sites need to worry about that. The CRAs need to worry about that. It's a mutual goal for everyone on the clinical trial.

Jen Stacy: 15:34

You're absolutely right and I always say, perfection is not part of the human experience. We're gonna make mistakes. I tend to find that the people that go into research are very type A personality. We absolutely do not wanna do anything wrong. We are very conscientious people. Having open discussions about mistakes is so challenging for people in our industry, but it's just part of life. It's gonna happen. And it's real easy for that CRA to walk in and focus and find what you did wrong as a site, because that's all they're doing. They're not running around taking care of patients. They're not picking up the phone and answering calls. They're not consenting, they're not pulling labs. To shift the focus, the mindset from, oh no, here comes that CRA, that's gonna find everything I did wrong, to realizing they really are your advocate. They're in your corner. They're there to help you and support you. And be sure that if the FDA walked in the door, that you are in the absolute best shape you can be and to support you. They're really your advocate and to shift that focus and realize, pick the phone, call them. They are always delighted to hear from their sites. So many of them will tell me at different meetings how meaningful their life is made by the relations they build with their sites. These sites are so important to them.

Jimmy Bechtel: 16:56

I couldn't agree more. Jen, and it's a great sentiment here. In our final couple of minutes, looking at that trial lifecycle, which we know is long and complicated, maybe pinpoint to wrap us up here, one or two best practices that Novotech might recommend to ensure sites are ready and compliant and are high performing throughout the lifecycle of the trial.

Jen Stacy: 17:17

The key point is communication. Reaching out early to set realistic timelines and communicate them to say, at my site it's gonna take me x amount of time to get through IRB approval, or we've already scanned our database and finding this patient is gonna be a little tougher than we thought, or, at our site we have a different patient pathway for recruitment. Let me talk to you about that. Or I only have a study coordinator available to do data entry Monday, Wednesday, Friday. Go ahead and communicate what the challenges are early and often. Don't be afraid to have those conversations. That's where solutions start.

Jimmy Bechtel: 17:55

Absolutely, Jen. I couldn't agree more, communication really is the foundation for everything that we do here and goes to speak to some of the other points that you made during our very brief chat today. It's one of those topics we could probably talk for hours. But I want to thank you for your time. Thank you for your partnership with SCRS, and thank you for leading a group of people who sound like they are truly focused on building the strongest relationship that they can with the clinical research site. So thank you and thank you for your time today,

Jen Stacy: 18:24

Jimmy. Thank you so much for having me here today too. It's been an absolute pleasure. I.

Jimmy Bechtel: 18:28

Well, thanks again to you, and for those that are listening, make sure to explore other site focused resources made available through SCRS on our website, my scrs.org, including other publications, more SCRS talks, and of course, our site solutions summits that are taking place throughout the year. Thanks again for listening and tuning in, and until next time.