Defining Quality: The Role, Responsibilities, and Industry


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Today we're excited to have Laura Araujo, Vice President of Quality at 4G Clinical share her insight into quality management. 

4G Clinical’s focus and mission is to bring crucial medicines to those who need them faster. 4G Clinical delivers modern, flexible and validated randomization and trial supply management solutions to Pharma and CROs faster than anyone else in the world. 

Laura has over 30 years of experience in Quality Assurance and Technology, holding various positions in Software Development, Quality Assurance, Software Auditing, and Technology Management. She has had positions in, or related to, the pharmaceutical industry for 25 years, including owning and running her own consulting firm for 10 years. During our conversation today, we talk about 4G Clinical and what they have accomplished, especially during the pandemic, Laura’s experience of working as a consultant, switching career paths and entering the Quality space, and much more!

Show Notes:

Music by keldez
Photo credit: Bryce Vickmark



We seek to transcribe the audio as accurately as possible. Please excuse any minor grammatical or misspellings. 

Robert Fenton: Laura, and there's a ton of things I'd love to talk to you about, I think for our chat today, what I think would be really interesting is we'd love to learn a bit more about 4G and how quality is impacting and why it's important to you folks and to your customers.

But mostly I want to talk a bit more about your role. Because I think it's, it's one of those rules where it's not like you study laws a t at the bar exam and then you get a quality role. That's often quite a more Securitas route, I think, to get in there. So before we get into that, uh, tell me a bit more about 4G  how do you folks kind of add value to life sciences?

How do you folks help help people live longer, happier, healthier lives? 

Laura Araujo: [00:02:11] Yeah. So our company is actually founded on  what has become our tagline, which is getting critical medicines to those who need them faster. Right? So we create, um, randomization and trial supply management software that sort of helps in the clinical trial startup phases, to really get studies up and running.

And what we bring to the table is sort of the amazing thing about 4G is the technology we use to do that. We use natural language processing and have built a system that can actually interpret the written language using natural language processing and build a system based on a written specification. It's pretty cool. 

Robert Fenton: [00:02:50] It is.  Let's talk a bit maybe about randomization. Why is randomization important in sample sizes and in life sciences trials? 

Laura Araujo: [00:02:59] Well, so primarily to eliminate bias, right?  And so when you're conducting any type of clinical trial, one of the goals of course, is to always conduct it not only with patient safety and everything in mind, but also to eliminate any potential bias. And that includes, you know, bias toward whatever treatment arm of subject might be randomized to in a trial. Right? 

Robert Fenton: [00:03:21] Yeah. Hugely important. Before using software, like you folks have built at 4G clinical,  what's the alternative to using software? Like you have 

Laura Araujo: [00:03:32] funny, you should go back. Well, if you go back, you know, 25 years, right. , a lot of it was done on paper. Where you'd actually mail out massive packages, you know, to all of the clinical sites around the world. It was literally crazy. And then, , the first iterations were telephone, interactive voice response systems.

So,  you know,  physicians would call into a telephone, push a bunch of numbers, right. And figure out what their subjects should be randomized. And in some cases, which those on envelopes from the mass mailing, they should hand to the participant in the trial. So our name 4G comes from what I'm fourth generation. It actually stands for fourth generation because we're the fourth generation of RTSM provider so

Robert Fenton: [00:04:17] I never knew that I should possibly have known. Yeah. Thank you for sharing that, Laura. 

So for those people who maybe aren't familiar with the clinical trials, even though I feel like the entire world is just taking a crash course and yeah.

So we might be able to skip most of that. I'll just state that, you know, purely working in this industry though, the promise of the promise that companies in life science does make across the arena. is I believe a co-equal promise to the promise that physicians make. So a physician taking the Hippocratic oath, right?

Part of that also will be this idea of, of the primary goal is to, first of all, do no harm. And in life sciences, there's this promise of quality we call it. And I'll start talking to you about quality in a moment whereby the goal is to deliver products and services that are safe, that are effective. And we're consistently clinical trials are like the last gaps like the last part for companies to really test and verify and make sure they deliver on those promises before they get out onto the market. So this whole service that you folks provide and making sure that the randomized is a really critical path for people to actually trust that yes, these products are ready for roads. So I appreciate the work that you folks do. 

Laura Araujo: [00:05:33] And recently, you know, we've been very busy with, uh, recent COVID trials, right? 

Robert Fenton: [00:05:37] Yes, of course

Laura Araujo: [00:05:39] Because our software enables us to go faster, um, and deploy studies much faster than our competition. We're able to get COVID studies up and running really quickly, which was key.

Right.  If you think back a year ago, right. And we needed these vaccines to be, available, right. 

Robert Fenton: [00:05:59] Yeah. What's the last year been like for you folks? 

Laura Araujo: [00:06:02] Crazy. It's crazy. Crazy. Good. Crazy in a good way. Yeah. , so interestingly enough, you know, we look at a number of factors,  for slow down in the industry and we've seen very little slow down and with the added, , Sort of responsibility around COVID trials and additional work around assisting with COVID trials.  We've actually done quite well.

Robert Fenton: [00:06:25]  Well, I think your, your mission statement resonates pretty strongly right now, because in the last year it seems that the world will, for a long time, the velocity,  speed wasn't quite so critical in healthcare. Generally speaking particular like new drug development.

Now  our new life sciences product development. And I think last year reminded everybody that speed matters. So I think what you folks are doing and shortening that, uh, has, uh,  a new resonance in the world. By taking, taking a step back from 4G and COVID how about you, Laura? How did you maybe tell us your story?

How did you go into quality and end up in this role? I think it's incredibly interesting. So, well, it's a long story, right? I, um, it's funny, you mentioned that, you know, people don't sort of get into quality naturally, right? It's sort it's own thing.  I actually did not start off in quality. I started off in software development a hundred years ago, and started questioning things in software development life cycle.

Laura Araujo: [00:07:24] Like, why are we doing this when, and why do you do this? And wait a minute, what happens if you make a mistake there? And actually the person who has working with at the time said, you know, you're not a developer, you're an SQA engineer, you know, quality. And so I've been in quality ever since. Um, I've been around the pharma industry almost 30 years and prior to coming to 4G I actually,  left the industry to, do my own thing for awhile. I actually ran a consulting company for 10 years. One of the founders of 4G approached me and, you know, they wanted me to join them and to start 4G we're only a five-year-old company. They wanted to start4Gwith quality as one of the very first pillars.

And I said, well, I have my own company and you know, which we now refer to the Jedi mind trick because, I ended up closing my company and coming here to join 4G and it was one of the better decisions I've made. So I've had a blast. 

Robert Fenton: [00:08:26] Maybe can you tell me more about that? Tell me what it's like in the consulting business you had. So you were a quality consultant. 

Laura Araujo: [00:08:32] Yes. 

Robert Fenton: [00:08:34] What type of company. 

Laura Araujo: [00:08:36] Pharma biotech, software development, um, industry, and some non-industry, but mostly in the industry pharma biotech industry.  And I did everything from,  quality system development to auditing, to writing standard operating procedures for them.

Robert Fenton: [00:08:52] What was it like working in, across such a varied set of clients? 

Laura Araujo: [00:08:57] Not what I expected and then more than I expected in some cases. , yeah, so I was sort of amazed at, smaller companies that had more in place than larger companies, believe it or not in terms of quality processes. That was very surprising to me. And I think it's just the evolution of some of these companies and the fact that they've been around a long time, um, and how they sort of grew up,  But each had their own challenges. Right on with large companies, it's a little bit harder to get things through and a lot, you know, a lot more stakeholders and red tape and smaller companies, you know, have the right mindset and just wanted to get stuff done. And so it was easier, um, to execute some things there. 

Robert Fenton: [00:09:40] I I can imagine. Um, because the software piece I can see now, particularly software as medical device become such a big area, but I think applying modern software development practices and  quality focus on that in particular, directly into like pharma biotech companies, possibly it was a cultural shift around, around that. Or was that not, not as big a challenge. 

Laura Araujo: [00:10:04] No, it's definitely true. You know, this is a very well, you probably know this, right. It's a very slow to adopt technology industry. Right. Particularly some of the folks that have been around a long time, very slow to adopt and very reluctant to switch providers. Right. So 4G as a provider, right. We suffered originally from new kid on the block, right. 

Robert Fenton: [00:10:27] Yeah, I know that feeling.

Laura Araujo: [00:10:29] Yeah. Right. Who wants to go with the new kid on the block where, you know, we're a  hundred year old pharma company. We're not going to go with somebody that was invented yesterday. Right. Um, so it's interesting. 

Tell me. So a lot of people who listen, work in the quality regulatory consulting sphere. And I think some of them also, we interact with people are thinking of doing this. I'm curious about, what are two or three things from your time as a consultant that you look back on and go that was really awesome.

 Probably one of the best things I have to tell you is, putting a quality system in place and then my clients go, we get it, we get it, Laura, we get why we need this. You know, I think a lot of consultants  there's different types of consultants out there too. Right. I think a lot of consultants Don't know how to scale based on the client that they're working with.

And if you're a really small client, you're not going to have the same level of requirements and procedures as a pharma, you're just not, you know, and so that ability to scale and to get them to go, ah, I get it, is really important. And the other thing is the why. Like, I think a lot of companies in this space know they have to do things, right. There's these regulations you've got to comply with the regulations, but they don't understand why. Right. What's the why, why do we do it in the first place? Why are these regulations in place for its place? , so that was kind of neat too.  Just the whole education. My background is teaching. I am a teacher. I have a master's degree in education. And so teaching was one of my favorite parts of consulting. 

Robert Fenton: [00:12:04] I actually do want to ask you about that and your teaching background, but maybe let's circle back to this concept of the why. What are the objections you might've seen, you know, from time to time as you've worked with companies, 

Laura Araujo: [00:12:18] The objections 

Robert Fenton: [00:12:19] well you know, before they get the why, but what are some of the challenges that you  have to overcome

Laura Araujo: [00:12:24] Oh yeah. 

Um, process is going to slow us down. We don't do process. Process. Process is going to inhibit our creativity, Laura it stifles innovation.  And 4G is living proof that that's not true. Right. 

Robert Fenton: [00:12:41] Watching your face there. I could have picture you could have gone for a long time listing, listing the initial objections. So I'm glad you stopped there. Yeah. So how did you bring people around on that? 

Laura Araujo: [00:12:53] Um, basically showing them right. You just have to do and show them. You know, I did a lot of process. Re-engineering a lot of sitting in rooms with people saying, okay, you create this document. You know, how hard is this document to create? Okay. Now what value add does this bring to you? Well, it takes us, you know, months to create it and yeah, it doesn't add any value. So why are you doing it? Well, somebody told us that we had to for this regulation, right? Yeah. You don't need it, you know, get rid of it. And so I think just going through those exercises and people realizing that process is here to help you not hinder you and not put big, long procedures in place.

That's not the goal, you know, never the goal of a quality system. 

Robert Fenton: [00:13:39] Unfortunately something that we've learned over time and how we've started to describing this, this may or may not resonate with you, Laura, is that the industry traditionally has had this idea that the artifacts of compliance are the goal.

Like it's as in the reporting is, is the actual goal. When I always found that really interesting, because you would think the goal is building awesome products and awesome business, saving lives. And people often say, well, that's different, but really the whole purpose of quality is to enable you to do that quote on harming people.

Laura Araujo: [00:14:15] Exactly. We have the big four. We refer to it as the big four here that drives everything we do at 4G. And that is, you know, we will not compromise the blind. We will not misdose. We will not mis randomize and we will not stock out during the clinical trial and everything we do keeps that patient and their safety and the clinical trial in mind.

Robert Fenton: [00:14:39] That's a really, really nice, um, how you said that. Thank you for sharing.

Laura Araujo: [00:14:44] I can't take credit for it. That's from our CEO. 

Robert Fenton: [00:14:47] You said it very eloquently. So clearly uh, the team has done a good job, sharing that with everybody. You mentioned teaching, and I've heard that you have a passion for art and you've been teaching art. So outside of your, your day job just feels like another day job.

Laura Araujo: [00:15:02] It was up until COVID struck and then unfortunately the art gallery that I taught at closed down because of COVID.  But yeah, up until that point, I taught elementary school education at a private gallery for many years. 

Robert Fenton: [00:15:15] That's amazing. Have you always liked art? Is that something that's always been close to? You? 

Laura Araujo: [00:15:19] Always. Yeah. In fact, I wanted to go to school for art when I was really, really young. And my father was like, absolutely not. You're going to be an engineer. You're not going to make money doing art. So that's why I went into engineering.

Robert Fenton: [00:15:33] Yeah. Well, I almost went to school to study music after graduating from pharmacy, but then I didn't, but I aspire to at some point in my life going back and pick up my guitar and playing professionally, but maybe never, I'm curious. Yeah about that teaching mentality. Uh, how has thattransferred maybe to coming into  companies like4G and helping teach quality?

Laura Araujo: [00:15:55] Yeah, , you know, quality is all about teaching. It's kind of interesting. This is another thing I've found a lot of people in our industry, fear, quality, because they're sort of known as the police officers, right? Yeah. Yeah. The cops, my, my philosophy has never been that. My philosophy has always been quality is here to help you right. And so essentially we are the teachers. We are the teachers to help you maintain your innovation. But do so in a safe and process documented way so that we can create it, recreate it,  share it with others.  So quality really are teachers. I mean, we really are at the heart of the matter, right?

Robert Fenton: [00:16:34] Yeah. Any, any advice for people who are in quality roles and maybe companies that might not be quite as, forward-looking as 4G Clinical, who may be coming up with some of those obstacles you mentioned that at the beginning, How can they show how you, how do you think those people can show their teams that quality is an enabler rather than an inhibitor? 

Laura Araujo: [00:16:56] Yeah, you know what, I think the best thing is small wins, right? Small pieces find your small, um, superstars that are willing to work with you and show them how  you can do it better. Um, and it doesn't have to be adversarial. It doesn't have to be the cop, you know, mentality, right?  Quality's here to help you that, you know, , and if you listen to them, I mean, really, listen, they're not going to tell you anything that you shouldn't be doing anyway. Right. I mean, everyone's like, Oh, Laura, it's required by regulation. I'm like, okay. It is, but it's really just good business practice guys. Right. This is just common sense stuff, you know?  

Robert Fenton: [00:17:32] Yeah. Well, you know what to say about common sense, um, for, for others, people  who might be interested in a career in quality. So you came in via the software. You're a software engineer who decided you were better at. Well, you moved into the software quality side and then into full on quality. Any advice from people who are thinking about a career, doing what you're doing now, who want to be in a role where they're, you know, part of the enabling enabler of, of companies to actually deliver on this promise of quality.  And maybe there is not a simple answer, I'm just curious about people who might want to get into your career. Uh, how do people do that? 

Laura Araujo: [00:18:12] Yeah, it's probably not a simple answer, I would say.  Unfortunately if you want to get in, because there isn't any real Formal curriculum. So have to start at the beginning. Right and if you can get with a mentor or in a company that has the right quality philosophy that's really where to go.

I have two people that work for me now.  One was the high school math teacher, and one worked for a nonprofit as an auditor and they've come here and have started with me in quality and we've been training them. They've been here a year and a half now, and they're good now. But it was a total career change and they wanted to do it. Yeah, I think it's fabulous.

Robert Fenton: [00:18:50] I think so. Thank you for sharing that. Is there anything else that you'd want to share with people who may be looking at this career path before we finish up today?

Laura Araujo: [00:18:59] I think people are afraid that, um, quality is sort of tops out. And I don't think that I don't think that's true at all.  I think you can go so many places if you have a quality background and if you branch off into other areas in the pharmaceutical, if you have that quality background, it only makes you that much more valuable. I think , because quality culture is really what this industry should be, right. Everyone should have quality at the forefront of their mind. 

Robert Fenton: [00:19:25] I use the phrase of it's it's a team sport. 

Laura Araujo: [00:19:28] Yes, absolutely. Yeah. I agree. 

Robert Fenton: [00:19:33] Thank you for joining and sharing some of your story today. You know, I'm a big fan of 4G  it's been really exciting watching you folks over the past few years, grow like exponentially over time and on behalf of everybody listening, I appreciate the work you folks have done with some of these trials, helping those go a bit smoother for everyone's benefit. And, uh, I'm excited to keep in touch. Thank you for taking the time today. 

Laura Araujo: [00:19:56] Awesome. Yeah, you guys have been with us from the start and we appreciate you putting up with our quick growth as well. 

Robert Fenton: [00:20:04] It's been our pleasure. It's exciting to watch you folks. 

Laura Araujo: [00:20:06] Awesome. 





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