Two Former CRAs on Trust, Technology and Friendship - Silvina Baudino, Maria Milas

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HANNAH LIPPITT: Hello

and welcome to the Totally Clinical podcast brought to you by Teckro, Totally Clinical is a deep dive into the freshest trends, big time challenges and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders and, most importantly, the people benefiting from clinical research. So, tune in, settle back and don't touch that dial. It's time to get Totally Clinical.

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HANNAH LIPPITT: So,

this week I am joined by two – yes, two – of team Teckro, or Teckronauts, to talk about the crucial role of clinical research associates in clinical trials. Now CRAs can often be overlooked, yet they keep the show going in so many ways, so it's really important their pain points are highlighted so processes can be improved and technology utilized to help make their lives easier. So without further ado, welcome Silvina Baudino and Maria Milas to the Totally Clinical podcast. Now both of you have already been on the podcast separately before, so it's really exciting to have you both here at the same time. Could you start by giving the listeners a quick reminder of your backgrounds and roles at Teckro starting with you, Silvina?

SILVINA BAUDINO: Yes, of course. Thanks, Hannah. So I started working in clinical research more than 20 years ago – a long time – as a Study Coordinator and later moving into the sponsor side for my first and then see roles with different roles that ranged from clinical operations to strategy until I joined Teckro less than a year ago to lead our site engagement strategy.

HANNAH LIPPITT: And you, Maria?

MARIA MILAS: So I started in clinical research as a CTA. So that's somebody who assists the CRAs, right – the monitors – in helping with documentation in the clinical trials such as well, keeping track of the documentation that's coming in, filing it in the eTMF, maybe keeping a QC of the eTMF and also helping the manager with the site.

After some time as a CTA, I changed into a CRA position for which I stayed for over five years. And then after my period of over five years as a CRA, I joined Teckro, and I joined Teckro as a solution consultant, and I am part of the sales team, and what we do, basically, is try to understand what our customers or prospective customers' needs and challenges

are. And with that in mind, we try to deliver customized demos of our technical product.

HANNAH LIPPITT: If we think about the role of a CRA, this kind of pivotal person who needs to be able to adapt quickly to different situations, as somebody with a background, as a CRA, could you explain your working relationship with other site members?

MARIA MILAS: CRAs’ main point of contact as a site is usually the Study Coordinator, so it is true that officially the Principal Investigator is the main responsible for the site and the site activities. But in real life, the PI is just the person who might put his or her signature on the documents and sees patients and delivers treatment to the patients.

But if we are honest, let's say in real life, all activities are performed or if not fully performed, they are at least prepped for follow-up by the Study Coordinator, and that's why the relationship between the Study Coordinator and CRAs can become very close. And let me give you an example of this close relationship. So the first thing I would do when I go on site for a monitoring visit is to grab a quick coffee with my Study Coordinator and catch up. Know what's been going on. Know how the study is doing. How is the relationship with the Principal Investigator? All those things that are more on the daily basis of the clinical trial. And then during the monitoring visit most of the time I spend this with my Study Coordinator, right? So, asking questions, reviewing discrepancies together, sitting together... basically for most of the day. And that turns the CRA and the Study Coordinator relationship

into a very close one and definitely a very important one down the road in the clinical trial.

HANNAH LIPPITT: Silvina, do you have any thoughts on what Maria just discussed?

SILVINA BAUDINO: I fully agree with Maria. It doesn't matter if the clinical trial, you know, is traditional or hybrid or decentralized. That relationship is crucial. That was my experience when I worked as a Study Coordinator many, many years ago, and I have worked with many different CRAs. Some of them were great, and some of them – to be honest – were challenging. I think that really a good understanding, transparency and collaboration are the pillars of that relationship.

Even when my experience, as I said, was a long time ago, when I speak with different sites and Study Coordinators right now, they feel that those principles are still relevant and timeless. As we know, things are getting more complicated. Trials are more complex, and there is additional burden just for not only for CRAs, also for the sites to deal with more technology, there is extra pressure. So, I think it's very important to help these people to alleviate their burdens so they can keep that relationship solid and transparent as it should be.

This is one of the reasons why I joined Teckro because I think it's very important to provide Study Coordinators, CRAs and any clinical research stakeholder tools to keep those relationships as the base of the good understanding and the success of clinical trials. Just to give you an example, my best friend used to be a CRA when I was a Study Coordinator

more than 20 years ago. That is the kind of relationship you sometimes have with your CRAs.

HANNAH LIPPITT: Oh, wow. And do you have any stories about the more difficult CRAs?

SILVINA BAUDINO: I think that trust is the base not just, you know, for any CRA and Study Coordinator relationship. It’s the base of any kind of relationship you have as a human being. I think that sometimes it takes time to build trust and some people have problems with trust, but it doesn't matter. So, you always have to

be professional and to deliver what you are supposed to deliver. But I must say that I enjoy some of the CRAs’ visit, and some of them were not that pleasant.

MARIA MILAS: Those are done by the CRAs who have the most number of monitoring visits per month, right?

SILVINA BAUDINO: Yeah!

HANNAH LIPPITT: If we think about recruitment, that's an aspect of a trial that's really challenging and sites struggle to find patients and sponsors want faster enrollment, and then you've got the CRA stuck in the middle. And this can be really time-consuming. Maria, can you expand on this and talk through some of your pain points when it comes to enrolling when you were a CRA?

MARIA MILAS: Oh Yeah Hannah, I think you definitely identified the biggest challenge in clinical trials: recruitment. So, recruitment, as you just said, is a huge, challenging moment in the clinical trial. So, on one side, you have the sites who are struggling to find patients and then on the other side, you have the sponsor who usually is pushing for a faster enrollment, and then you have the CRA who's somewhere sitting in between those two roles.

Now what this situation translates into is that the sponsor is constantly going to ask the CRA, “How is the site going? Do they have any candidates in mind? When are they going to consent that patient for which we were discussing about?”, and all these questions are going to get to the CRA and the CRA will pick the phone and call the Study Coordinator because the Study Coordinator will be the person who will have the answer to those questions, right? So that means time. It's time that we are taking

from our site staff to actually look for patients and actually enroll those patients and those candidates. And there has to be a better way, a more optimized way, right, to allow our sites up to have more time to tackle this extremely challenging moment in clinical trials.

HANNAH LIPPITT: And Silvina, if we think about much of the work you've done with sites, you'll really understand just how important communication is as one of the key problems that needs to be solved. It's like everything, like with many things in life, everything comes back to communication.

SILVINA BAUDINO: Sponsors are very eager to, you know, to reach their milestones, and sites feel the pressure to deliver what they have promised before. And obviously, because you are starting a new process – you are executing a clinical trial – is the time when you tend to make more mistakes because it's something new. So that adds a lot of pressure to the relationship between the CRA and the Study Coordinator. Not among them, but because the CRA feels the pressure from the sponsor and the Study Coordinator, sometimes from the Investigator and the rest of the study team. So I think that it's very important that... try to keep calm. It's almost impossible, but really stay focused on, you know, each step and it's a goal that is shared between the sponsor and obviously at the site because at the end of the day, we all care about patients. So this is one.

I think the relationship is put really under everybody's eyes and it's important to, because it's when you start building

trust, right? If you can overcome that very difficult moment, this really sets the tone for the rest of the relationship along the trial. So, it's very important that we need to help everybody to make this situation easier and provided to really keep that relationship solid.

HANNAH LIPPITT: Maria, do you have any more examples of communication problems you've experienced?

MARIA MILAS: I was traveling to a site in Spain for a monitoring visit. I was on a flight and when I landed, I had 16 – yes, 16 – missed calls from one of my Study Coordinators. And whenever that happens, a monitor knows that something bad happened, or at least something went wrong, right? And at that moment, you basically think of 10 different scenarios of what could have gone wrong. So I landed from my flight, I called my Study Coordinator, my Study Coordinator didn't pick up the phone at that time, and I tried calling – of course – several times during the morning and when finally we could talk, there was a frustrated Study Coordinator on the line telling me that a biological sample was lost, because they didn't know what kits to use to ship that sample to the lab.

And how can that happen? How is it possible that because we didn't have that direct line for communication, we lost a patient biological sample?

HANNAH LIPPITT: Hmmm.

MARIA MILAS: Imagine that situation.

HANNAH LIPPITT: Yeah, it must be like, your heart skips a beat!

MARIA MILAS: Definitely!

HANNAH LIPPITT: It's so interesting to think about why trials are run in the way they are. Mistakes like this happen. Real problems, and why they've been so slow to adapt. Do you have any thoughts on this, Silvina?

SILVINA BAUDINO: If I look back when I started – like ages ago – now, changes are going at a faster pace than they used to be. To give you an example: to move from paper case reports or forms that everybody knows is CRFs to electronic data capture systems like EDC took more than a decade. Yes, 10 years to adjust, you know, and I was told that there are still few studies out there that are using paper, believe it or not. But when we think about now... paper and fax really sound very obsolete. But that was the first big step in terms of technology adoption for me compared to what we see right now. Now, many processes had to be adjusted because there is a new reality. Remember, at that time, we didn't have tablets or smartphones or all the digital systems we have right now, and we need to change the way, how we capture information and how we communicate to each other, right?

So, all these changes which experienced really an extra push of acceleration with COVID, can be overwhelming. Not just for CRAs – for sponsors in general, for sites and also for patients. And in the middle of this change, the changing times, it’s not a secret that protocols are becoming more complex and the evolution of the protocol design is not moving at the same pace that technology is moving.

So there is this connection there because protocol design is changing at a slower pace and technology is coming. Currently, as you know, everybody is talking about patient inclusion and diversity. This is the real hot topic in clinical research, but these two changes need to go at the same speed. I think that is really what we need to make the big change that is needed still in clinical research.

MARIA MILAS: I definitely agree with you like that. The biggest thing I can see that has changed during my – let's say, not that long – experience in clinical trials, but to technology definitely has made a great impact in clinical trials. And it's definitely a great thing because it helps the Study Coordinators, it helps the investigators. It helps not deal with so much paper. It helps the environment, even, right? But in the end, what we see nowadays is that our investigators or Study Coordinators end up with so many credentials, with so many tools, with so many websites that they have to log into with so many applications, that sometimes it's very difficult for them to actually remember which one to access at each specific clinical trial and for each specific patient visit.

Technology is definitely helping the clinical trials to evolve and to develop faster, but for now, we're still, let's say, having that burden of having too many vendors or too many credentials or too many things to keep in mind still. And then on the other side, I would also say that because clinical trials is a huge field that's being developed in the last few years, our investigators and our sites have a significant amount of clinical trials at the same

time, right? So, running at the same time, that means that you will have a very large number of people – of roles – involved at the same time, and it's difficult for our investigators to keep track of, “Oh, who's this CRA on this trial? Who’s my sponsor contact on this trial? Who is my Study Coordinator or my pharmacist for this trial and the one that I'm having a patient visit tomorrow?” right? So there's still, I would say, we still need to figure out how we're going to take some burden out of our investigators.

HANNAH LIPPITT:

It's interesting, actually. I was speaking to somebody the other day who was talking about investigators and how often they just want to do one trial and then they don't want to do any more. So yeah, it's – a real problem.

MARIA MILAS: It's a burden for them, I would say their main objective is still the patient care, right? So, if we add on top of that and it becomes more difficult and it becomes a burden for them, some investigators will opt to just stick to the patient care.

HANNAH LIPPITT: It's interesting to think about the future as well and the direction clinical trials will take in the next couple of years. We've obviously just been through a difficult couple of years with COVID, and lots of changes have come into force. I think I've spoken to both about this before, but do you have any other thoughts on how CRAs will need to adapt Maria?

MARIA MILAS: As a CRA we're going to go into more offsite activities, so maybe even more site management from home or even more monitoring visits from home. But definitely as a CRA, I believe that... you will need to have as much communication happening with your sites as possible. Because slowly and slowly, we're going to go less on sites, right? And that human interaction is going to be needed to still have an idea of what's happening and to give support to your study, to your site, as much as they need

it, right? So, we definitely are going to adapt to it. See how we adapt. Maybe we're going to have one tool that will provide us with all – everything – we need to run the clinical trial. So ideally, that's what the series will help, right? One single tool for the clinical trials, and they can do all the activities through there, all the communication, all the side management, all the monitoring, but it's definitely going to be less on-site monitoring visits and activity.

HANNAH LIPPITT: Silvina, do you have any thoughts on this topic?

SILVINA BAUDINO: Everything goes back to communication, right? And it's challenging to build a trust and that relationship in a remote way. Not everybody feels comfortable working remotely, and I agree with Maria. We will see more like remote visits versus in-person. But there are a lot of things that are still to be seen, because if we talk with different sites and sponsors, it seems that the model that we will see more in the future will be hybrid. And I think that this is something that has to change to engage more physicians to continue working on clinical trials, and not just one time, as you mentioned, Hannah, because that is the only way we can engage more patients, have a more diverse patient population and provide access to clinical trials to more patients, is to have more physicians involved.

And I think that in addition to technology, it should be more friendly and really helping sites and CRAs and not being like... you're making the stakeholders feel like extra burden and should be, right, a tool. I think that in addition to that, we need to see a change in the protocol design that should be more flexible. This is what I see. I foresee for the future. I know that some sponsors are asking patient advocacy groups and sites to provide feedback about the design and early stage, and this is what we need more and more, so protocols can really be executed in real life and not like something that isn't completely out of reality.

And the other piece really is to give more flexibility to patients. I know that as you mentioned during these last two years, things have been very, very difficult because of COVID. But some patients don't feel comfortable doing everything remotely.

They want to go and see in person. Their providers, their Study Coordinator, their physicians. They feel that their care is different and we need to respect that. So what I foresee for the future is that some of the protocol visitors clinical trial visits will be more flexible, and the patient could make a choice to do the visit in person or remotely or in different ways. I think that is the future, more flexibility – that at the end of the day, this is what will improve communication.

HANNAH LIPPITT: Thank you so much, both of you, for coming onto the podcast, and it's been a great conversation.

SILVINA BAUDINO: Thank you.

MARIA MILAS: Thank you Hannah, great to be here. Just as a thought to, you know, bring home with us... the clinical trial’s main purpose is to bring treatment options to patients, right? Sometimes it's even for patients who have no other treatment options in the market. Maybe somehow, let's just think each one of us of how we can take some burden out of our investigators, so that they can focus, and so that they can have more time to actually make it happen, right? Make those patients have an option to treatment.

SILVINA BAUDINO: I fully agree, and this is the reason why now I am full circle. I started at the site, then I moved to

pharmaceutical company to a CRO and now I am like part of Teckro – it’s a vendor – to be part of that future because still there are like many things that are broken in the system and we are helping or trying to help, to repair or to provide additional tools. I think that we always said: “Make things more simple.” It's not just about acceleration, it's about simplicity, too.

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HANNAH LIPPITT: And that's your dose of Totally Clinical. You can download our podcast on Apple, Spotify and Google. Please subscribe and leave a rating and review. So more people can find the show. See you on your next visit and remember to bring your friends. Thanks for listening! Goodbye!

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