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Online Training and Document Storage: An Interview With Justin Goodarz

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How has COVID-19 affected the way clinical trial sites conduct their training programs? Join Darshan Kulkarni as he talks with Director of Business Development Justin Goodarz about the changes happening in the clinical research industry in response to the pandemic. Plus, why sites are turning to online training programs.

Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. We have Justin Goodarz. And I've known Justin for probably about 10 years, but we've sort of always been the same circles. I have some very good memories of us hanging out. I think it was DIA where we hung around afterwards, and maybe it's [inaudible 00:00:24] or something else, but hang around afterwards, having drinks. And this podcast became a great reason to reconnect with old friends. And I have this opportunity to do it again with you, Justin. Justin, do you want to tell everyone what you're up to now, what you did before, and sort of what makes you awesome at what you do?

Justin Goodarz: Yeah, yeah. Sure. Awesome. I'll take it. And I think it was initially when we first met was DIA about eight years ago in Philadelphia. I was brand new to Greenphire at that time, so entry level that we were hosting our Greenphire event there at DIA and they made me walk around to handout flyers all throughout Philly to different restaurants to try to get some traction there. I mean, Greenphire wasn't what it is today obviously. It's a household name now, but I think that was the first time you and I met at DIA, Philadelphia.

Darshan: Can I be perfectly honest? You may not remember this, but you were so new and Greenphire was so new that I remember asking you, at one point it came a bit of a challenge, if I could find the most off the topic thing and you found a way of getting into Greenphire. It was the most awesome thing to watch. It was great.

Justin Goodarz: I mean-

Darshan: We've all sort of grown and it's impressive seeing you do the things you're doing now. So tell us what you're doing now then.

Justin Goodarz: Thank you. Yes. So about three years ago, I made the transition from Greenphire to Trifecta Clinical based out here in Los Angeles. So I made the transition from Philadelphia to San Francisco with Greenphire, and then from San Francisco to Los Angeles with Trifecta Clinical.

Darshan: That sounds horrible by the way. I mean-

Justin Goodarz: Responsible-

Darshan: I mean, just beautiful sunshine. It must be horrible.

Justin Goodarz: Tough life out here. Yeah, it's been a very simple transition for me.

Darshan: Fair enough. Fair enough.

Justin Goodarz: [inaudible 00:02:23] Philadelphia. I mean, I love it out there, still have family and friends out there, but I think LA is home for the foreseeable future.

Darshan: Oh, is that right?

Justin Goodarz: But working for Trifecta Clinical, director of business development, so responsible for the West coast, a couple other key clients globally, and we're doing some cool stuff. So very excited to dive into what we do, but more importantly, talk about the industry and what's changed over the past couple of months.

Darshan: So obviously we'll do a little spiel at the end, but tell me a little bit about what Trifecta does just so we're all on the same page and why you know-

Justin Goodarz: Sure.

Darshan: ... lot about this stuff we're going to get into.

Justin Goodarz: Yeah. Yeah. So what we provide is a critical site communication platform that is used to support three different features. The first is the delivery and documentation of global site training, investigator training. The second is the distribution of safety letters or SUSARs with acknowledgement of receipt. And then the third is regulatory document exchange. What we've seen is by leveraging one platform to support various different processes it enhances site centricity by reducing portals that they must log in to, enhances inspection readiness by maintaining all of that documentation centrally, which would have historically been stored at individual research sites or not even stored at all, so to streamline processes and, and make things a bit more compliant.

Darshan: So you raised a few different things that I definitely want to explore. The part that I want to start with is the training part of this. In a world where COVID is becoming... well is, has shut down the world, do you see more sites coming on for training or are you seeing... Because I think obviously your platform provide some opportunities because it's virtual and you can train people, but has everything basically shut down or are things still happening? What are you seeing out there?

Justin Goodarz: Yeah. So we're starting to see things come back online a bit. Obviously everything did shut down. Everything moved over to support of COVID-19 trials. Oncology was the other therapeutic area that really didn't slow down as much. That kept on. But everything else besides that pretty much came to a screeching halt. What we are seeing is things are starting to come back online, but it's going to be a very staggered approach because, I mean, there's no way to predict when certain cities, states, countries are going to open up. Some are going to open up and some are going to potentially shut back down again. And so leveraging a site communication platform what we've seen to deliver on demand training now, delivering that training when it's necessary for this site to take that training rather than multiple virtual investigator meetings is really the direction where we're seeing the industry move towards.

Furthermore, I mean, what we saw was there was a pivot from... Obviously there weren't any more face to face investigator meetings. So there was a quick pivot to these virtual investigator meetings leveraging something like a Zoom. In reality, when you've got an entire family that's working from home, kids are home from school, it's impossible to sit in front of a computer for four, five, six hours and really digest the information that people are teaching.

And so what we've seen is now limiting what's being caught during a virtual investigator meeting. What we've done is we call it essential documents. So we strictly focus on protocol specific training during a two hour window. And we deliver non protocol specific training either before the virtual investigator meeting or after the virtual investigator meetings. But then what we also do is we capture everything that goes on during the virtual investigator meeting. We turn into topics specific modules. Then we deliver that training to the research sites, all of the research sites.

Now, for those who did attend the virtual investigator meeting, they will get credit. They will not have to actually take that training again through our platform, but they have the ability to reference that training out throughout the duration of the study. For those who were not able to attend the virtual investigator meeting, they get a welcome email. It tells them that they have to complete their training through our platform. Once they've completed all of their training through our platform, a training certificate is generated, and then they have the ability to reference that training throughout the duration of the study. But now you've centralized all that training documentation, because you could see who had attended the live virtual investigator meeting versus who completed training through our platform on demand.

Darshan: So-

Justin Goodarz: So that's the trend that we've seen from face to face to virtual. And now it's a hybrid approach between virtual and on demand training moving forward.

Darshan: So I guess the question then becomes, how do you do... I mean, there's so many ways to pivot this new type of knowledge and infrastructure that you guys have created. The one thing I'm thinking of is number one, do you see Zoom as a competitor, first of all, or do you see them as augmenting what you already do?

Justin Goodarz: No. We see Zoom... Zoom serves its purpose for something like this. When it comes to really supporting a virtual investigator meeting you need something a bit more robust. You need people that are actually... The way we approach it is from a project management standpoint. We have a 30 point checklist that we will go over every single time we're planning for one of these virtual investigator meetings. We've got redundancies in place. So if one platform goes down, let's say, we've got a backup platform that can immediately replace that. So we are ensuring the success of that virtual investigator meetings, because we know how hard it is to get everybody in a room at one. So we are going to do everything that it takes to make sure that this goes off without a hitch.

And then one of the most important things as well because we are a production company is being able to capture this, edit it into a topic specific module to take out the ums and the Is or the sneezes, and then deliver that post five days after that virtual investigator meeting. So these sites can get activated much quicker and start enrolling these subjects much faster.

Darshan: So if you're doing all of this, you've obviously got the system going already. Have you looked at using it for events? DIA is going on right now come to think of it actually, our eighth year anniversary, right? But DIA is going on right now. And there are all these other conferences I'm speaking at. If you already have the system together, are you looking to potentially leverage and do other types of markets?

Justin Goodarz: I do not believe we are looking to do that right now. We are strictly focused on the clinical research space. I think there's enough market opportunity there. So I think that that's where we are laser focused right now. I don't think that we really want to go into different areas at the moment.

Darshan: That's not the target market. Fair enough. No, to me it's so interesting because when we started in probably about March, right, everyone was talking about, "I don't know what to do now." And I feel like we're now in, what is it? June? And in June, I feel like now people are really getting the sea legs under them and they're going, "Okay, I know how to do this and I know how to do this right." And the more I talk to people, they're like, "I have a system. And if you buy into my system... I'm not saying I'm the only system, but I'm saying that I have a system and it works. And here's why it works."

Justin Goodarz: Sure.

Darshan: And it's interesting to me to see someone like you actually in a market going, "This is the market I'm in. I could do a thousand other things, but that's not what I'm trying to do. I'm trying to be the best at what I do right now." And I just thought-

Justin Goodarz: Sure.

Darshan: ... that was really impressive. So kudos.

Justin Goodarz: Thank you. Thank you. Well, I mean, it's funny. So we didn't just start because of COVID-19. We've been around for over 15 years now. You know the industry that we work in. It's very slow in to adopt. I mean, we've had clients that are only now truly embracing what we do because they really didn't have any other options. So I mean, we've been around. It was always slowly trending in this direction, more adoption, but this was definitely the fire that was needed to get people a bit more engaged in what we do. And that's what we do in a much more meaningful way.

Darshan: So here's the question. Will it stick after COVID? Sort of in Pennsylvania, we're already talking... in Philadelphia, we're talking about going green right now. We're going from phase red to phase yellow to phase green. Do you think that companies are going to go, "You know what? This is good. We're glad to have this in our back pocket, but we don't need to stay here"? What do you tell them to go, "This still works and this is probably better for you"? What is that better for you? What is it that they can do now that they couldn't do before?

Justin Goodarz: I mean, right now it's... We've always been dealing with status quo. It's a fundamental change that's happened but out of necessity versus want. What we're seeing is that I do think people are really going to start scrutinizing the amount of money that they spend on a live face to face investigator meeting. They serve its purpose. I mean, it's always great to establish a relationship with the sites. And actually we've recently done a survey, which I think you'd find pretty interesting, on the industry's mindset on investigator training post COVID-19. It's a pretty cool survey. We don't think that face to face investigator meetings are going to be coming back in a strong way for the next 12 to 24 months. Eventually they'll come back, but we're not sure if they'll ever be the standard again.

What we're seeing is that people are scrutinizing the cost associated. They're now thinking more about the flexibility for the research sites, because it's tough. If you're a PI that's working in a therapeutic area, you've got five, six different sponsors coming at you, it's hard to leave your office for multiple investigator meetings. And then you're probably sending your coordinator. And then it's the trainer mentality of teaching training. And to be honest, that's kind of a broken process as well, train the trainer.

So we are going to see much more virtual investigator meetings, but I think that leveraging a platform really does need to be the backbone of your site training infrastructure because it will store all of the documentation but it does allow flexibility throughout the duration of the study, because you have to think about training. It doesn't happen at one point in time throughout the duration of a study. It happens at the beginning at the investigator meeting. It happens at the site initiation visit. It happens when there's amendment training, when there's site staff turnover. And leveraging a platform to support the delivery of all that training as well as the documentation of whenever and wherever that training is taking place is really the only way that you're going to achieve a perpetual state of inspection readiness really.

Darshan: So that raises a few different things for me. So the one thing I was thinking about is compliance will love you. To a matter of the hammer, everything looks like a nail. I do a lot of compliance work and general counsel services for a lot of companies, and the key piece that comes out of it is am I paying fair market value or am I taking my investigators to Hawaii for investigator training? Well, now the argument becomes why do you need to take them at all. Do it online. So there's obviously an advantage to that.

But you said something that I thought was interesting. I'm trying to connect your thoughts. When we started the conversation, again, I hope this was when we were recording, but I asked you which states were affected, did we slow down or was it still sort of active. And you said it was mostly COVID and oncology that was primarily active. And then everything else sort of slowed down, and now people are rethinking their methods. But you also said one thing in the middle, which was it's important to recognize that people default to what they already know. So the companies that sort of just shut down for a while, their default will still be live investigator trainings. Meanwhile, oncology and COVID trials are going. We've moved on. Our new default is online trainings, and obviously over time, that'll all change. But what do you say to those people who are still mentally defaulting back to, "Here's what we do. We already have 15 reservations across 15 hospitals in 15 countries"? How do you bring them to the new normal, if you will?

Justin Goodarz: Yeah. Well, I don't think any salesman is going to be able to do that, to be honest. I think they need to hear it directly from the site. And so we do take the approach where at certain conferences like SCOPE, for example, we set up a booth and we actually interviewed research sites. "What is your preferred way to receive training? What is the COVID site server that we did? Are you going to feel comfortable traveling for an investigator meeting?" And you take that information... And then it's not us selling you our technology.

Darshan: Sure.

Justin Goodarz: It's you hearing it from the research sites and you making the best decision that you can make based upon what the sites are requesting. I think site centricity needs to be one of the most important factors. Don't get me wrong. Again, there's always an argument to be had for a face to face investigator meeting, and they are necessary. But you really got to pick and choose when to have that face to face investigator meeting.

So for example, if you are doing a program with three studies and there is 100% site overlap, there's no reason why you need to have a face to face investigator meeting for study two and three. It's just a much more expensive process for no reason really. You've established that face to face relationship. There's probably not much of a difference in between protocols. And so leveraging technology to support the training moving forward for two and three would probably be the most cost efficient and streamlined way. I mean, you'll get the sites up much quicker, much faster by delivering training all at once, rather than having to schedule three months down the road, pick a hotel for those folks that could make to the live meeting, scheduled the site initiation visits. But leveraging technology, you can streamline that process in a much quicker cost efficient way.

Darshan: So if you're doing technology and you're leveraging technology the way you're suggesting, how do you combat what everyone's calling Zoom fatigue, which is I can sit in front the computer and have another eight hour long meeting?

Justin Goodarz: Yes. I feel for this. So that's where we've seen the pivot from a virtual investigator meeting to on demand training. So you roll the training out to the research site or to the PI or to whomever needs to take it from the comfort of their home really. They can log in over let's say three weeks, take that training when time permits, and then once they've completed that training, that training certificate is generated and there'll be able to then start rolling research sites. So the flexibility, allowing them to take a little bit of training during lunch, a little bit of training the next day after dinner when they put the kids to sleep, that is what we are seeing become the preferred modality to deliver and receive training.

Darshan: Goodarz, again, coming from a compliance viewpoint, are you able to then give a report of all the people who attended, what they watched, do you actually have engagement components in there, so answer this question, what is the right answer kind of thing, and then give it to compliance with a report at the end of whatever period?

Justin Goodarz: Absolutely. So in terms of the documentation and reporting, it's on demand self service. So at any point in time, you can drill down into an individual research site, or you can view a holistic view of the training. There's even a report that shows which site is ready for the site initiation visit or to be activated because every single person at that site has completed 100% of their training. So the documentation from a compliance standpoint is bar none the best I've seen personally out there, as well as what I've been told from our clients.

In terms of engagement tools, yes. So absolutely depending on the therapeutic area, there's going to be an assessment. So if you're working within dermatology, atopic dermatitis, and there's a rater scale, a validated IGA scale. It's a usually a little bit of a training video and then there's an assessment at the end. And we document all of that as well. We can even document how many times somebody has failed prior to passing that assessment.

But then we also have something that's proprietary to Trifecta Clinical, which is something called the Watch Code. So if you do not want to put an assessment at the end of a specific training topic or module, we have something called the Watch Code, which based upon a certain algorithm will populate however frequently it's been determined by you, the sponsor. So let's just say for all intents and purposes, we've got a 20 minute training module. At minute 5 and at minute 15, this bar populates at the bottom and it says, "Type in numbers 5156 and then click enter." The training doesn't stop. But what will happen is it will time out from 60 seconds down to zero, and it will shut down if you have not typed in that 5156 number. So if you, Darshan, we're taking on demand training and you thought that you were going to click the play button and walkway and go get lunch, you come back, that did not happen.

Darshan: Can I just tell you, I hate you right now so much because I'm having CE flashbacks right now. But it's obviously effective. But-

Justin Goodarz: It is.

Darshan: Yeah. But-

Justin Goodarz: And again, that does not have to be across the board. It can only be on certain modules. They could populate [inaudible 00:21:17] many times you deemed fit. So yeah.

Darshan: After taking these pharmacy courses... I'm a pharmacist, as well as, as you may remember. But we have to take these child abuse training continuing education credits, and there's a free one out there. And the free one requires us to do exactly the kind of stuff you're talking about. And it's supposed to be a three hour training course. I think the last time I was at it for nine hours and I still hadn't finished it. So it shows you the level I was focusing into that, but anyways, You talk about providing training. The second part of this... And I think you actually I'm going to make a slight pitch for you because I think it's important from a compliance viewpoint. And just to be clear, I have no stock in you guys. So I'm just sort of having a conversation.

Justin Goodarz: Yeah, private company.

Darshan: Private company. But I think it's kind of important to think about the fact that from a compliance viewpoint the big question is, is your technology Part 11 compliant? And you guys, you told me earlier that you are. And that becomes useful for me because that means that the data itself is being tracked and the results themselves are being tracked and you can sit and modify them. Has there been any question or consideration of moving to something like blockchain to put that in there? Because Part 11 is really about inability to destroy records. And again, blockchain allows for something like that. So has there been conversations around that or is that still proprietary?

Justin Goodarz: I'll be completely transparent. That has not been discussed with me whatsoever. So I have-

Darshan: [crosstalk 00:23:01].

Justin Goodarz: ... no idea. Our CEO is extremely tech savvy. So I'm sure he's bounced around that idea. I would be naive to think that he hasn't thought about it, but if he has, he has not conveyed that message to me.

Darshan: There's another reason to sort of push back on it, which is the FDA has not opined on what their view on blockchain for this format would be. So I just didn't know... It was an interesting thing to explore. Another thing you mentioned, Justin, a little bit ago was this idea of sharing SUSARs. And let's first talk about what SUSARs are, and then talk a little bit about the importance of doing that. And I guess one of the questions that comes out of it is do you... One of the things I keep seeing over and over again, I'm sorry, this is like a three part question, but-

Justin Goodarz: Sure.

Darshan: ... is the idea of patient centricity and making sure the needs of patients is being considered actively throughout the process. If that's true, does the ability of sharing SUSARs quickly, how has that patient centric and how does it help? And is that an active consideration? Are you guys looking more to investigators to do that as part of their system, if you will?

Justin Goodarz: So you actually bring up somewhat of a pretty good point. We mostly focus on site centricity, but patient centricity, I guess, plays a factor to having all the investigators know that this one subject had an adverse event. And making them aware of it as quickly as possible I think there is an argument for it to be said that it is patient centricity as well, because then they have the ability to remediate that issue potentially. So that's interesting. What we do is we absolutely streamline that process. So it could potentially with certain integrations, it could be almost a fully automated process as well. If it's a standalone process we're using our platform, what you're doing-

Darshan: Before we jump further, Justin, could you explain what a SUSAR is by the way?

Justin Goodarz: Yeah. So I can't get into too much detail. We do have a subject matter expert that usually we loop into the equation. So what we do is we send out a safety letter or a SUSAR. And what that means is if there's an adverse event that takes place with a specific subject within a clinical trial, that every single research globally needs to be informed that this adverse event took place with this particular subject at this particular research site. Now, there's also certain rules and regulations around who needs to be notified because of this adverse event. So if that takes place in the US every single research globally that's involved in this study must be informed. But there's certain other countries where if there's an adverse event, only research sites within that country need to be informed.

So we've configured that into our platform, but we lean on regulatory, either at the CRO or sponsor level to determine those rules. They're easy to configure within our platform. They're not hard coded in there. And we do lean on you guys, because there's a little bit of a liability if you're putting that onus on us.

Darshan: So here's the question. You talk about SUSARs have a requirement of you notifying people. One of the questions I've struggled with is should we be moving towards not you being the sponsor, notifying people but people having received the notice? Imagine, I'm just actively thinking through this, if I have an account, you have the ability now to keep reminding me that I just sent you this information. You need to look at this and acknowledge receipt if you will, almost. And from a sponsor viewpoint and FDA viewpoint, not just a liability perspective but from a patient centricity perspective I'm on notice that this happened. Is that an active consideration of how you guys design the system, or is it more meeting regulatory requirements and saying, "I've notified you. We're good"? Does that question make sense?

Justin Goodarz: Yeah. No. 100%. And I think you nailed it. It's not mandated to have a solution in place to acknowledge receipt of the safety letters or SUSARs. We are on our third version now of our technology. And it's based upon feedback from the industry as well. We are seeing that this is a very hot topic throughout the industry and that having been proactive and capturing these acknowledgements is becoming a standard as well. It's not mandated, but we are seeing it become the preferred process moving forward. And so what we do, it's extremely simple to use based upon the country rules and who is supposed to be receiving these safety letters at a given research site, it's an email blast with a hyperlink. They log into the portal. What makes it 21 CFR Part 11 compliance is they just type in their username and password, click enter, and that is their stamp of receipt. And then all of that is stored centrally within our platform as well.

There's some other cool things that we can do. You can acknowledge multiple letters at once. If that compound is in multiple studies, you can delegate responsibility. So if the PI is out on vacation, they can actually have the sub-I acknowledge that that letter has been received. But if you think about how the industry works, obviously there's a lot that's being outsourced to CROs, and we see the CRO business growing and growing and growing over time as well. But there are certain things that are being brought back in house like site payments, for example. That's a solution that was brought back in house because the sponsors want financial oversight.

Safety letter distribution is a solution that's coming back in house because that's a process that should be standardized across the organization. When you're outsourcing that responsibility and you're using multiple different CROs, that means that sites are receiving multiple different ways to receive the safety letters because multiple CROs are using multiple different processes. So there's certain things that are great to outsource to a CRO. I'd say site payments is not one of them. And safety letter distribution is probably one that we're seeing come back in house in a meaningful way as well.

Darshan: We usually go for about 15, 20 minutes. We're well above that. So I'm going to ask you one last question before I let you tell people how to reach you. But who is your actual audience? Is it CROs usually coming to you guys going, "We don't know what to do. We need to pull you in"? Is it sponsors going, "I don't trust my CRO"? Or, "I just need a partner to my CRO"? Or is it sites sort of a groundswell coming to you going, "We need all this stuff in place"? I'm going to guess it's not the third, but still-

Justin Goodarz: Actually you'd be surprised. The feedback from research sites has been overwhelmingly positive.

Darshan: Oh, [crosstalk 00:30:27].

Justin Goodarz: It's a very user friendly system to use. And we've done surveys in the past, and again, there's a little bit of an asterisk, but we've done interviews and sites have said that they would prefer to take training or receive training through our platform rather than going to an investigator meeting because of the flexibility. They don't have to leave the comfort of their home. Now, in terms of who I'm targeting, I mean, CROs and sponsors, yes, I'm targeting both. They both can absolutely... There is significant value that can be realized by both. They work differently, though. I mean, a CRO many times is just working on behalf of the sponsor. They come to you and they don't really even fully understand how your technology works. And they're kind of just checking a box many times, so to speak.

My job has been trying to get in there in a much more meaningful way, explain the value, because if I can convey the value to them they can convey it back to the sponsor. And then it's a win, win. When I'm working with the sponsor directly, there's a bit more engagement because we do become the default for their site training strategy and their safety letter distribution strategy as well. It's a true enterprise wide strategy because working with Trifecta to support training, we can support training wherever and how a training takes place.

So if you're going to have a face to face investigator meeting, great. We're not an event planning company. We're not going to book a hotel for you now. We're not going to do that. But what we will do is we'll send a production team onsite to that investigator meeting. We'll capture all those presentations. We'll then turn those presentations into training modules, and we'll deliver that training to the research sites that are unable to attend within five business days. Same thing with a virtual investigator meeting. We can support the virtual investigator meeting. We'll capture that then deliver the training to the size. And then we could just strictly do complete on demand training as well.

So what we want to do is if a sponsor is planning a study, if you need to... Obviously investigator training will be a key component of that. We want to be there to help you guys not only support the delivery, but also the documentation of that training as well.

Darshan: I'm sorry. I know that was supposed to be my last question, but two more questions came out of that. My one-

Justin Goodarz: I'm open.

Darshan: My one question was that... Again, I think we said this before we started recording, but one of the things you said is, "I'm not DocuSign. I don't sort of sign off on things and that's not what we do." But do you guys have APIs that connect with DocuSign? Is that a capability that's available?

Justin Goodarz: I don't know if it's necessary, to be honest.

Darshan: Oh, tell me why?

Justin Goodarz: I mean, everything is tracked on the back end anyway, in terms of people logging into the platform to receive their training. I mean, we document the percentage that's been completed. We document how much time has been spent on each individual training module, and only once somebody has completed 100% of their training that's when the training certificate is generated. And that's how our business model works in terms of revenue as well. It's a very risk based sharing model. Your goal is to have your research site completely trained and compliant.

The only way a training certificate will be generated is if they've completed 100% of their training and then that training certificate is generated. And the only way we get paid is there's a unit costs associated with each training certificate. So we invoice the following month based upon the number of training certificates that have been generated. There's no monthly management fees, there's no licensing fees. So if we didn't have a simple user-friendly solution to use sites, wouldn't be logging into our platform to complete their training and we wouldn't be getting paid. So-

Darshan: But you were talking about how you guys are a document repository almost. And I didn't know if as part of that document repository, like 1572, do they need to be signed? And do you guys do that? Do you guys pre sign ones and you then have it in the system for access if you will?

Justin Goodarz: A 1572, I believe that that needs to... So this is getting into our regulatory document exchange technology. And I have to get one of my counterparts. Yeah, yeah.

Darshan: That'd be a different person to answer those questions. Got it. I'm with you.

Justin Goodarz: There would be, but there is a log associated with every single time somebody logs into our platform. All of that is documented as well. So I mean, we really do go above and beyond what is required in terms of documenting, what happens behind the scenes.

Darshan: That makes sense. The other question I have is, again, this is obviously giving... And I recognize some of these questions may not be things either you've been asked or it's not within your purview. So that's totally okay, or you may not know the answer. But when you're engaging with these companies, obviously the big thing that they're worried about is FDA audits. Have you guys ever been audited by the FDA as far as you know?

Justin Goodarz: We do not get audited by the FDA. We are there to support our clients as they are getting audited, but we do not get audited by the FDA.

Darshan: Okay. Fair enough. So I was trying to figure out that. Have you guys been audited by your clients?

Justin Goodarz: Yes, constantly.

Darshan: Okay. Okay. So that's what I was trying to figure out. So you guys are used to that system of auditing. What has that experience been like from an audit perspective, receiving those audits from clients? I guess I've done it with sites, I've done it with CROs, I've done it with sponsors. I've done with distributors. I'm curious, and I don't know if you know the answer to this question again, but what do sponsors tend to look at and ask you about when they're auditing? Is it like the Part 11 compliance that's really most interesting to them or is it something different, or is it the IT audit? Is it a high trust audit or whatever it is?

Justin Goodarz: It's a mixture of both. I mean, we also go through validation with certain clients as well. But it also depends on the solution. Training, it's not as robust of an audit because it's a training solution. It's really just looking that the training documentation is stored centrally. Whereas if you're auditing our safety letter distribution solutions, because that's a GSP solution, there's a bit more involvement that goes on there. In terms of really everything that they're checking, that's our quality team.

Darshan: Fair enough.

Justin Goodarz: So I've seen some of them. Some of them are extremely long, depending on who the sponsor is. Some of them are virtual and pretty simple, really just depends on who you're dealing with.

Darshan: Awesome. I don't have anything more. How do they reach you if they have questions?

Justin Goodarz: They can go on to Trifectaclinical.com. Check out the entire website. We've got a ton of really cool case studies that we've been doing. Our marketing guide, Joe, has been crushing it over the past couple of months. So it's very interesting stuff that we've been sending out there. My direct contact information is [email protected] And if you're calling from... if it's an inbound for somewhere outside the West coast, I'll be happy to introduce you to one of my counterparts as well.

Darshan: Well, this was awesome. Thank you again for coming on, Justin. This is really great. Let's do more of these when you have some time.

Justin Goodarz: Yeah. I'd welcome the opportunity. This is cool stuff that you're doing, Darshan. I hope you and everybody have been able to stay safe and sane throughout these couple of months and good luck with everything.

Darshan: Thank you.

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