Clinical Trials · Episode
Adam Baumgart — RBQM, AI in Clinical Trials & 38 Years of Hard-Won Pharma Wisdom
In this episode of the Pharma Prescribed Podcast, host Adam Walker sits down with Adam Baumgart, a veteran of the pharmaceutical industry with over three decades of experience at organizations like AstraZeneca and Covance. The conversation dives deep into the evolution of Risk-Based Quality Management (RBQM) and its critical role in modern clinical trials. Baumgart explains how RBQM has transitioned from a niche regulatory requirement to a foundational element of trial integrity, emphasizing that the true goal is not just compliance, but the early identification of risks that could threaten a study’s success. The discussion explores the transformative impact of artificial intelligence and machine learning on clinical data review. Baumgart provides a pragmatic perspective on these technologies, positioning AI as a powerful 'copilot' that helps clinical trial leads navigate the overwhelming volume of data generated in modern trials. By automating the identification of outliers and trends, AI allows human experts to focus their attention where it is needed most. Listeners will gain valuable insights into the convergence of data monitoring, medical review, and risk management, as well as Adam’s vision for a more integrated, efficient future in clinical operations. This episode is essential for professionals looking to understand how to leverage technology to improve trial quality without losing the human element of clinical oversight.
Chapters
Approximate · derived from transcript
- 0:00Podcast Intro
- 1:45Meet Adam Baumgart
- 3:31Adam's Mission in RBQM
- 5:17Mission and RBQM Passion
- 7:03RBQM Explained in Plain English
- 8:49RBQM Explained Simply
- 10:35Career Path into Clinical Research
- 12:21Mentors and Life Lessons
- 14:06Giving Back Through ACDM
- 15:52Tech Evolution in Trials
- 17:38Key Skills for Trials
- 19:24Critical Thinking in Trials
- 21:10Data Science and UX
- 22:56Programming for Clean Data
- 24:42Building RBQM from Scratch
- 26:27CTQ Factors First
- 28:13Accountability and Mental Health
- 29:59Visualization and Discipline
- 31:45Advice to Younger Self
- 33:31Team Qualities That Matter
- 35:17Passion Balance and Teamwork
- 37:03Life Outside Work
- 38:49Golden Rule and Wrap Up
Key insights
Shift from Tabular Data to Proactive Risk Management
RBQM is often treated as a bureaucratic checkbox, but its true value lies in acting as an early warning system that allows teams to proactively address site performance issues before they compromise a study.
AI as a Copilot Rather Than a Replacement
AI should not replace human judgment; instead, it acts as a 'copilot' to filter through massive datasets, highlighting critical outliers so clinical teams can focus on strategic decision-making.
Converging Clinical Data and Quality Workflows
The industry is moving toward a future where data review, medical monitoring, and risk management are no longer isolated silos but integrated into a single, cohesive workflow powered by intelligent platforms.
Bridging the Gap Between Technology and Clinical Expertise
Effective AI implementation requires balancing algorithmic precision with the clinical expertise of study teams to ensure that automated insights are medically relevant and actionable.
Newsletter issue
Fewer surprises at database lock
35 years across CROs and pharma on making risk-based quality management make sense, and why a clinical trial is best understood as a people-based process.
The written companion to this conversation with Adam Baumgart. Browse the newsletter archive
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Full transcript
Edited for readability. Speaker labels preserved. Click to collapse.Click to expand.
Full transcript
Edited for readability. Speaker labels preserved. Click to collapse.Click to expand.
Podcast Intro
Adam Walker:I'm Adam Walker, a biometrics consultant, and this is the Pharma Prescribed Podcast where leaders, innovators, and hidden voices in healthcare open up, no sound bites, no spin, just raw insight, one prescription at a time. In an industry driven by data protocols and pressure, we rarely pause to ask the human questions.
What drives us, what breaks us, and what truths live behind the titles we wear.
Meet Adam Baumgart
Adam Walker:As an advisor and consultant at ZedE Associates and CDO Consulting, leveraging three years of consulting and 35 years of CRO and pharma experience, Adam Baumgart's passion is enhancing risk-based quality management and clinical trial processes.
He provides strategic input on AI models to optimize RBQM, clinical data review and site monitoring to improve efficiency, enabling data-driven. Decision making and minimizing project risks. Adam's previous leadership roles at AstraZeneca, Cova and elsewhere emphasized transformational change, operational efficiency, and functional leadership.
His broad expertise spans Lean Six Sigma risk management. Data management, clinical monitoring and organizational design, underscoring a commitment to driving innovation and operational excellence in life sciences. Adam is passionate about his family, mental and physical health, and the impact of RBQM transformational change.
Adam's Mission in RBQM
Adam Walker:Adam, it's a delight to welcome you to Pharma Prescribe today, but those of our audience who are not familiar with you, who are you and what is the mission you are on?
Adam Baumgart:Good morning, Adam. It's an honor to be here. It really is. I've listened to a bunch of your podcasts and you've got some real high profile people on here, so I'm honored to be included cheers.
Mission and RBQM Passion
Adam Baumgart:what am I am a biometrics and risk consultant. I suppose that's the best way of summarizing it. 35 years. Experience in pharmaceutical research and clinical research organizations which support pharma and in technology organizations. And I've done so many roles, I've lost count. So I have a very broad experience across a variety of roles, especially around the running of clinical trials and processing data from clinical trials, working with doctors who support clinical trials.
And so that's been. My focus, but over the last, let's say 14, 15 years or so I've discovered a true passion around risk-based quality management, which people listening, are gonna go what the heck is that? We, within the clinical trial industry. Have to abide by regulations and there are some regulations out there, some guidances out there, and two of those guidances have been updated over the last five years or so, and those have made a huge difference to the way that we have the opportunity to operate.
And let me say again. Have the opportunity to operate. Sometimes we do operate like that. We've introduced risk management, for example. We've introduced analytics, that kind of thing. I want to make that change. That's what I'm passionate about. I'm passionate about blending that risk management, the use of analytics, the change in roles that this brings.
And that's the change I want to bring about in the industry. That's what I wanna do. That's what I'm doing.
Adam Walker:Thank you for explaining that, Adam. And I'm relatively new to understanding the world of risk-based quality management myself. Yeah. And we've had various conversations on the topic from a very simple sense, what is it?
And
Adam Baumgart:yeah.
RBQM Explained in Plain English
Adam Walker:On a day-to-day basis, if I'm working in clinical research, what do I need to know and understand about it? And if I'm not in clinical research and listening to this podcast, what on earth is it?
RBQM Explained Simply
Adam Baumgart:Yeah it's a, it's become a very interesting thing for me, so I'm nerdy about it.
Adam Baumgart:But let's break it down into four simple areas.
So there were ideas a whole bunch of years ago in total quality management. Introduced in companies like Toyota in Japan, for example. So total quality management brought the concept of quality management to the production processes, manufacturing processes. So then how do we apply that to business based processes, to people based processes?
And which is what a clinical trial is. It's a people based process. You have patients, you have the clinicians, the physicians, and you have the sponsors who conduct those clinical trials. So risk-based quality management, RBQM is an approach that has emerged from the latest guidances. Four main pillars, a quality by design approach that is done to build in quality into the processes that you've got, a quality risk management approach where you de-risk and manage risk within your trial, a quality control approach where you are managing that quality on an ongoing basis and a quality assurance approach.
Which is where you guarantee and measure the quality. So those are the four main pillars. In reality, the difference within a clinical trial is we're now doing risk assessment much earlier for every clinical study. So it's making a huge difference in de-risking our trials, and we've got fewer surprises now as we run through our clinical trial as we collect patients.
As we collect that data, as we clean that data, as we analyze it, there are fewer surprises that come up. So that's basically quality by design and quality risk management, those two elements. Trying to de-risk your trial at the beginning, standardize as much as possible, build quality by designing, and then monitor the risks during the course of the clinical trial.
We use analytics and things like that. Quality control and quality assurance. The other two pillars we already had, we were already doing, we were already checking what we were doing and we already had quality assurance departments. So bringing those four pillars together is really what risk-based quality management is.
Quality by design, quality risk management. Quality control and quality assurance.
Adam Walker:That's a very nice way of summarizing it, and I appreciate you doing that because. My simple mind, those four pillars make perfect sense. And as you say, we've always had quality control and quality assurance within clinical research.
Adam Baumgart:Yeah.
Adam Walker:It fundamentally underlines everything that we do. I'm wondering, how did you get into this particular area, because I don't think it's something you stumble upon and in the manner in which you're describing it, you are clearly very interested in that level of detail and yeah. Assurance around those clinical trials, how did you end up this becoming the thing for you?
Career Path into Clinical Research
Adam Baumgart:Gosh it's been a long journey 38 years I think now within the pharmaceutical industry in various roles. And I think the broad nature of the roles that I've been in has helped me understand the impact of a big change, like risk-based quality management. So that broad. Exposure that I got early in my career to data, clinical data has helped.
But I fell into this, I think, like many people within this kind of industry. I fell into this, I fell into clinical research. I was a scientist at university. So basically applied biology is what I studied. I realized I didn't enjoy. Lab work particularly I did enjoy field trials, so I was involved in agrochemical field trials.
So that was a little bit of an introduction to clinical trials to an extent. So it was really from having gone and done a number of industrial placements at university, field trials were interesting. I tried to get into field trials, but Agrochemicals fairly dangerous. Bad for the environment.
You didn't want to get into that and I didn't want to do lab work, so I looked around for opportunities in using a science-based background and I'd always been keen on, on computers and what was around, at least then in the mid eighties, late eighties. And I fell into clinical data management much the same as yourself, Adam, it was an early start for me before technology.
And from that I did a whole bunch of different roles in the industry. I moved from looking at data for a few years to then serving investigator sites and helping them run clinical trials. That was fascinating. That was in Africa and the Middle East. And then moving into basically procurement and then project management.
And then leading teams, and then leading departments. So it's been quite a journey, but the biggest change, and I suppose the biggest influence has been learning about Lean and Six Sigma. So process improvements, so improvement approach, and then applying that into the new regulations which started coming out in what.
Something around 20 around the area of 2014 to 2017 is when the first changes in good clinical practice came along in recent years, and that just opened up a whole opportunity to approach things differently. So all of a sudden I found myself diving into this area, which I understood just inherently.
I just understood it because I understood the role of a site monitor. I understood the role of a physician at the doctor's site. I understood what was happening to patients. 'cause I was monitoring sites. I understood the flow of data and collection of data, and then I understood how that data would impact the analysis, but down the line.
So all sorts of things just started falling into place for me, and I just understood the impact of our BQM on what we were doing, and it just became. A real passion and to then bring about a change like that in the organization I was working for. So I was working at cova, a contract research organization, and I led the RBQM or RBM initiative as it was then risk-based monitoring initiative as it was previously called.
And I led that for four years and we achieved immense results and introduced new departments and new roles and de-risking of studies and so it was a great experience.
Adam Walker:It's a really wonderful example of continual learning. Yes. As you were describing that, I was hearing just, yeah the desire and zeal for gaining new knowledge, learning new things, and acting upon those.
Mentors and Life Lessons
Adam Walker:Were there any mentors particularly that supported you in that? Because it strikes me that of course. You were climbing a very long ladder, but along the way people must have looked out for you because you are a good guy. And I've known you for a little while now, and I would imagine you made some very strong connections along the way with people that were helping you
Adam Baumgart:Oh yeah.
Adam Walker:I think,
Adam Baumgart:yeah. Immensely. Immensely. I won't go into names, there were key people that employed me or mentored me during my career. Very significantly a company called Glaxo Med, which was a pre Glaxo Wellcome. Pre GSK Glaxo Med was the operation that looked after Africa in the Middle East from a commercial perspective.
There was a physician there who was superb. And I learned a lot from and then moving to clin trials, RAs research. There was a head of data management there who was instrumental. And my growth from kind of managerial level to director level, absolutely instrumental. And then more recently in joining kind of AstraZeneca, two very key leaders there were very strong mentors.
But I think one of the things we may come onto around balance between work and life, another key mentor for me was my father-in-law. So I lost my father when I was very young. So I was five years old when I lost my father. So I was brought up in quite a female-centric home. When I got married, my father-in-law turned into this amazing human being, just an incredibly generous, an incredibly positive person.
And he dedicated his life to his wife because his wife became in firm. And so for his whole retirement, he looked after his wife as she got. Progressively worse. And despite all of that, he was a refugee after the second World War and had to make a living. And then he had this terrible news as he approached retirement about his wife becoming in firm.
So that all sorts of factors in his life that could have made him a very negative person, but he wasn't, he was just the most positive. Inspiring human being. So those folks both professionally and personally have been very inspiring.
Adam Walker:I do appreciate you sharing that, Adam. And it's interesting because this is a theme that comes through many of the conversations that I've had on the podcast, that along the way.
Successful people have been helped. And it's a message I want to put out there to many of our audience because we have Absolutely, we have young people listening to this wondering how on earth they get into this industry. And what I'm hearing from you is that there were people along the way, both.
Both in your personal and professional life, but also how important is it to have these. Guardian angels that look out for you along the way that sometimes soften a very rough path. I also have experienced that in my career, and it's been instrumental and in the connection that you and I have, there comes a point at which people help one another and you find your people.
And in the way that, you and I have connected and become great friends over these last few years I think of you as a mentor as much as, everyone is passing something down. I also do that for various other people as well. And I love that kind of handing over of experience and guidance and as I say, just softening that path a little bit for others.
Adam Baumgart:Absolutely. One of the key things I discovered a little bit late in my career, I was heading up departments and trying to do things by yourself. And that doesn't often work. That's more of a leading to failure than a leading to success. And you learn just as much from failure as you do from success.
But I remember coming to a point where I thought, I can't continue. Operating the way that I've learned to operate. I have to learn new ways of approaching things or learn from other people, and I started reaching out to people. I started talking and asking, and for mentors, and that was very powerful.
So one of the greatest mentors I had was a physician at Cova. And he's been through very difficult personal tragedy himself. But he mentored me. I asked him and he mentored me, and that was one of the single most inspiring set of change and, behavioral that I've felt from and that giving from that individual was just extraordinary.
Ask for it. Yeah.
Adam Walker:As you say, that experience not only forms you, but I think. If I'm hearing you correctly, it also drives your own determination to then support others, which I know you do a lot, both person Absolutely. Personally and professionally.
Giving Back Through ACDM
Adam Walker:Are you happy to talk a little bit more about how you support other people in this industry and perhaps, passing on the baton to the next generation?
Adam Baumgart:An example doesn't really spring to mind, but let's talk about some of the work that we both do actually with the Association for Clinical Data Management. Sure. So it's a professional body. It represents. The function, the role of collecting clinical trial data, of reviewing it and cleaning it and then preparing it for analysis.
So there are whole hordes of people around the world that do this role. One of the ways I've tried to help others is by teaching and by courses and by contributing. So for around 10 years with a colleague of mine. We ran the advanced clinical data management course for project management.
So we did this for about 10 years, and I've lost count of how many people we trained during those 10 years. We started off, I think with around 25 people on each course, and we were doing it twice a year. They probably whittled down to around 10 and perhaps running the course once a year. But over the course of 10 years, that's a good couple of hundred, 300 people and people come up.
Oh, you talked to project management years ago and I'm sorry, but I don't remember you. 'cause there's so many people that we taught. That was always good to share the experience of managing a project. And now I volunteer on the, an expert group on risk-based quality management for the association.
And we run symposia. Once a year. And that's all done on a volunteer basis. So it's just about sharing of knowledge and trying to put information out there and making connections with people. It's good fun.
Adam Walker:I, also love the A CDM. Activities, and I think that was when I first came across your name.
I think I was one of those people that came to some of those trainings. And your name obviously is the same as mine, your first name, but your second name is quite memorable. There aren't too many BA guards around that's not to, bring your name into question. It's just merely to remember that.
Your name stands out. It always stood out for me. And then when you and I connected at an A CDM conference a couple of years ago we properly connected on a, on an emotional level. Dare I say it. I think there was something in the water and we've continued that friendship and connection ever since.
And I'm so pleased for that.
Tech Evolution in Trials
Adam Walker:On the point of, what you're seeing around technology today, you've seen a lot.,
Adam Baumgart:Yeah.
Adam Walker:It's extraordinary to think how long you've been doing this in this industry. Yeah. Because. You don't look that old to me and
Adam Baumgart:oh, stop it.
Adam Walker:When you're talking about the eighties, I'm thinking, my God, I was at school listening to culture club then.
But it's funny because I'd love to hear your perspective on what you've seen over that time because
Adam Baumgart:Yeah,
Adam Walker:I, I asked this question to many of my guests, purely because, you'll have seen an awful lot. And I'm not saying it was the chalk and blackboard when you started, but it probably wasn't far off that.
Adam Baumgart:Yeah. It's pretty close.
Adam Walker:Yeah. Can you give some perspective to what you've seen and where you're seeing the industry of clinical research, drug trials, and everything associated with that now?
Adam Baumgart:Yeah. Gosh. So it was 88 to 89 when I started, so that's a good while ago. So we were collecting data off paper.
So we were sending paper to doctors' sites where clinical trials were being run, and the doctors would fill out the forms. It'd be on non-carbon required paper. A copy would come back to us, A copy would go to the data entry team. A copy would stay at the site, the data entry team would enter the data twice, then there'd be a crosscheck of it.
It seems like an eon ago. And so from moving from paper to integrated databases was a big change. So we introduced electronic data capture, so internet-based collection of data, web-based forums, all that kind of thing. And so when those first started being introduced I spent a little bit of time working for one of the first companies that, did that.
So it was called Face Forward in those days. So we led a team of people who designed that interface that the doctors would enter information into or rather perhaps study nurses would enter information into. So we went from paper based processes essentially collection of information from the doctor's sites to web-based entry.
With checks firing at the point of entry. But for some reason, our queries were still on paper. So data queries, data questions about some error would always go by paper. That changed over the years and the systems became more electronic where it would all be web based and the queries would fire from the systems as well.
And I guess where we are now, thinking more from that data and the data. Data cleaning perspective. We've got integrated databases now where the systems will allow us to take a look at that data holistically for a patient. So you can see trends better, you can see visual representations of risk. You can see visual representations of the patient profile.
So those things are just massively different. To those early days of just focusing on a piece of paper and seeing what the question was and seeing if it was collected. So I guess the resource levels have changed. We need more and more people to do this. We've collected more and more data in clinical trials, our trials, and more and more complex than they used to be.
We're in more and more therapeutic areas, more and more indications, rare diseases. All we're doing is we're just collecting more and more information. The complexity of what we do is now, it feels exponentially different to where we were when I first started.
Adam Walker:Thank you for elaborating around that.
Key Skills for Trials
Adam Walker:And I think to follow on from that, I'd love to know what you think some of the real key skills for people coming into this industry now would really be helpful. Because you and I have adapted to. Many of those changes that have been whether forced upon us, we've been front and center in many of those changes.
Yeah, and I'm thinking about data, technology, documentation, exactly as you say, this proliferation of enormous amounts of data that has just
As you say, exponentially risen in that time. What are the kind of skills that we ought to be encouraging young people coming into this industry to gain and learn and have?
Adam Baumgart:Great question. One of the things that keeps striking me is or keeps impacting me as I think about what we do nowadays versus where we were.
Critical Thinking in Trials
Adam Baumgart:So I, do a lot of risk management. Or de-risking of clinical trials. So I'll take her read of a study protocol and read through it over a series of hours and then try and conclude what are the most important things from that?
What are the key risks that are gonna be ongoing? So to do that, I use a lot of experience, which obviously can't come into an industry naive with experience, but certainly the ability to question things, the critical thinking in, is this gonna work? For the patient that patient's having blood tests every week or they're having a colonoscopy once a year and they're a child.
These things just, they can prevent a trial from being practical. So that critical thinking, I think is a really important skill to learn or to practice. In coming into clinical trials now, because that, I think is becoming more important, especially as RBQM that whole approach to de-risking clinical trials, to monitoring risk as we go along through a clinical trial thing is essential.
Data Science and UX
Adam Baumgart:I think the other areas I would advise is our industry is changing so rapidly.
Adam Walker:Yes.
Adam Baumgart:With the. Onslaught I would say of AI and large language models and that kind of proliferation of fast ingestion of data and fast use of data. You need to understand data.
If you can learn data science, if you get some exposure to programming, you get some exposure to analytics, you get some exposure to user interface design as well, that's becoming more and more important. I was looking at some user interfaces yesterday and I was bringing a risk manager lens to that.
And there was nothing telling me how a risk in a clinical trial should escalate. So you can see it straight away, but it's a red flag. It's just a table of information, a very simple table. So that user aspect, the user design aspect of things and how we design them for use at an investigator site, I think is really important.
So we talked about critical thinking. We talked about that kind of data analytics perspective. But I think the final thing is you can't get away from being a good relationship builder, building relationships either with investigator sites, which we will not get away from. We need data from investigator sites to prove that clinical trials deliver what they need to do to prove that their drug is efficacious and is safe.
The ability to build relationships with very intelligent people, not be intimidated by those relationships, I think is essential.
Adam Walker:Those are extraordinary, powerful points that you've made there. And as you were talking, I was thinking about that myself. Critical thinking is something that underpins, I think many.
Many aspects of our work and it's often overlooked. We are just expected to be able to, as you say, review protocols and identify what are the key points that drive data decisions through. It's not something that comes easily. I still struggle with that and I'm happy to say that, but I've learned like you alongside many medically qualified people and we're fortunate that We are surrounded by amazing minds and amazing brains.
Statisticians perform an incredible role in clinical trials. Absolutely. But often get overlooked as well. And your point around programming and the analytics I think is really timely because. Around that data science piece. Really, it's a broad skillset, isn't it? And I've said this to many of the mentees that I work with is if you get an opportunity to do any coding right now, whether it's R Shiny SaaS, whatever, hy, I think those are the top four.
That would be very helpful. Having an understanding of programming. And I'm not a programmer.
Adam Baumgart:Yeah.
Adam Walker:But I know what I want it to look like at the end. So if you have that skillset and you understand that under the hood you can really fly very quickly, can't you?
Adam Baumgart:Yeah.
Programming for Clean Data
Adam Baumgart:I think, that skillset around programming, which I've only spent maybe two years, maybe three years of my career actually programming, but it was so interesting. I got a bit nerdy during that time, but I did solve a problem around presenting errors in clinical data management.
Analyzing the data from a clinical trial, seeing where it's wrong or may have errors. Information was coming at me as a data manager. I was programming and doing data management at the same time. To manage information was coming to me from the programs to say, look at, let's say safety data and then it would for one patient and then look at safety data for another patient and then look at efficacy data for a third patient rather than doing a patient centric review.
And so the programming capability was just a small program that I developed a macro in SAS, and organized the information. So I would get the data for a whole patient all the way through. And so we drove that patient towards being clean earlier because we weren't looking at bits of data all over the place.
We focused in on trying to clean the patient. So that experience of programming that, or solving for that problem just helps me understand what I'm trying to do. Now, if I have a problem over here that I know I've gotta convert into a standard. That is then maintained or input ingested by an ai.
That standard needs to be robust, otherwise that AI is not gonna interpret the information correctly. So that programming experience has been absolutely invaluable.
Adam Walker:Yes, it's logic and it's many of the components of. The and or buts.
Adam Baumgart:Yes.
Adam Walker:All of those types of logic.
Adam Baumgart:Yeah.
Adam Walker:When you're pulling in data from different points it's a great, point.
Really well made and I really appreciate you elaborating on that.
Building RBQM from Scratch
Adam Walker:This is a very broad question, but it strikes me that with the experience that you've had across your career, if you could redesign. Any RBQM framework, would you start from scratch and how would you start? Where would you start?
So let's say for example, I'm a company now and I know I need RBQM, but I've got a blank canvas and it's yours. Where do you start?
Adam Baumgart:Yeah, so I was at a conference not too long ago in November. So it was the symposium that the data management expert group for risk-based quality. Management did in Amsterdam.
We had about a hundred people there and we had a massive panel discussion, very interactive with the attendees. And I was asked pretty much the same question because you can over-engineer and you can over complicate and therefore make it very difficult to implement.
CTQ Factors First
Adam Baumgart:So there's some principles within the guidance documentation from the ICH organization.
So ICHE eight revision one looks at general considerations for clinical trials and that introduces you remember the four pillars from earlier. The pillar of quality by design and the main learning from that pillar is something called critical to quality factors. Simply put, they are the top.
Let's say 4, 5, 6 things that are the most important thing in your clinical trial, and you define them and you agree them, and then you measure them. If we, at least as an industry, start with that, that is a very good start. So I try and suggest we go simple with an organization first. Start with defining what is most critical and then build everything else leading on from that, because that filter out all of the noise further down in the clinical trial.
So a good example there is that we can reduce the number of active risks that we're de-risking. So if you just go into a risk assessment and say. My study now has, oh, I've got a list of a hundred risks and I've scored them, and 50 of them, or 60 of them are high risk. You're not gonna be able to manage that within the clinical trial.
So defining what is important, what is critical to quality at the beginning of the trial can help reduce that down by 50% so you can get to a point where you are perhaps actively managing 20 risks, 25 risks. For example, and you can distribute that amongst all of the team that supports the clinical trial.
Adam Walker:I think that's really helpful and thank you for explaining that. I feel I need you in my toolkit when I'm reviewing these protocols and I've got some upcoming work in which I think just the way you are describing that I need you on my shoulder here just to do that first pass. We might need to get a CDA in place to do that, but I can see the absolute value of those critical to quality factors because
Adam Baumgart:Absolutely, yeah.
Adam Walker:Effectively you're saying what's the big thing that's gonna catch me out? What's the thing that we don't know? And it's anticipating that in advance, isn't it? It's almost like having a look at the deck before and seeing what cards are gonna be
Adam Baumgart:Yeah.
Adam Walker:Flipped over. Yeah. Because you've anticipated them.
And I think there's a really powerful insight. I really do. Thank you for elaborating on that.
Accountability and Mental Health
Adam Walker:There's a couple of, other aspects that I'd love to go into, Adam and of course you and I we met at a conference. We got to know one another and over the last, I don't know, year, we've been checking in on a Monday morning with a certain chap called Ryan Park.
Yes. Who has been certainly instrumental for me. I think he's been very helpful in your life. I wonder if you would mind just elaborating about that a little bit further.
Adam Baumgart:So if your listeners haven't listened to your podcast, where Ryan is interviewed, they should because he's a very strong young man who has taken an idea and a concept about helping men's mental health and just turned it into.
A giving of himself basically on a volunteer basis to groups of men helps those men manage their levels of stress, their levels of sadness or depression. And it's been remarkable. I've been through the program now. You have, we meet together on a Monday morning, so we see each other at least once a week, and we just check in.
We check what objectives, goals we had for the last week. We check what we enjoyed most about the previous week what we've learned from the previous week, and what are our goals and objectives for the next week. And so that simple act of accountability is very powerful. I run around on a Sunday night and scribble down everything just so that when I wake up on a Monday morning I'm ready and I'm ready to go.
But I think equally hearing other men. And some of the struggles that they go through, because we don't talk, men don't generally speak about how they're feeling. I think that is gradually changing. I think it's for the better. But it's good to be able to be there for other people, men in this case.
But I would broaden that. I would, listen to anybody. It's not about it being exclusively. A male domain. I think the principles that Ryan has put forward are an incredibly positive approach to empowering yourself and focusing on your objectives and getting things done.
Yeah,
Adam Walker:very useful. I would love to echo that and I think. Having introduced you to Ryan as well. Yeah. I've seen a transformation in you and not just your performance and outlook, but actually I think the way in which you've embraced the future, your future, and we've both experienced some challenges in the last year or so.
Adam Baumgart:Yeah.
Adam Walker:You've had loss. I've had loss, and we have had to be there for other people. I know you've experienced a lot in this last year and. I hope it's been not just instructive, but as you say, there is a community of like-minded souls who are looking out for each other, many of whom I've never physically met,
Adam Baumgart:yeah.
Adam Walker:It doesn't matter, does it? And one guy is in Sydney, Australia
Adam Baumgart:doesn't, it doesn't,
Adam Walker:it's not his Monday morning, it's his Monday afternoon. But we're all over the uk and you never know who's gonna turn up. It has certainly been instrumental for me and I wanted to share that with you because I thought it would be helpful knowing you and I'm delighted that you have embraced it because as I say Ryan came into my life when I needed him to.
I hope he's done the same for you.
Visualization and Discipline
Adam Walker:And there is one thing that we've both done, which is the visualization piece with Ryan that I think. Is one of the most powerful things I've ever done and has just Yes.
Adam Baumgart:Yeah.
Adam Walker:Set a touch paper to motivation.
Adam Baumgart:Yeah.
Adam Walker:Now, without elaborating on your particular one-to-one.
Was that your experience? How was your experience of that?
Adam Baumgart:Yeah, that's a good question. Perhaps my experience wasn't as profound. But it was empowering, if I can put it that way. I'm a little bit older and perhaps I've done, lots of different things. So for me it was the rigor and the discipline.
The visualization, all those things combined have pulled together to basically check in at the end of the day. And I say, have I been productive or not? I'm quite forgiving of myself if I haven't been. 'cause we're only human and I think we're allowed to have ups and downs. Generally speaking, within a week, I am much more productive than I was say a year or so ago.
So it is made the difference to me absolutely, and you have been my mentor in that, so don't forget that. I think it, it works both ways. So I very much appreciated and understood and try to empathize with what you've gone through in the same way as you've done that for me. Ryan has done that for both of us, and Ryan has done that for a whole bunch of other men who've been through all these training courses that he's run.
The framework helps for men, just the way that we're wired, just the way that we operate. It's very powerful.
Adam Walker:I agree. And I don't think it even takes a certain type of person to be impacted by it, although. I do find that there is a certain common thread that runs through many of the people who are involved in it.
So just a shout out to Ryan. I love the guy. I think he's wonderful. I think we both think he's wonderful. I still have not met him in person.
Adam Baumgart:Amen.
Adam Walker:And when I do, I will give him a very big.
Advice to Younger Self
Adam Walker:At this point in the conversation, Adam, I'd like to finish with a quick buy around, and I'm wondering what is the one piece of advice you would give to your younger self?
Adam Baumgart:It's a fairly straightforward one. Follow your passion for heaven's sake. Follow your passion and follow your interests. And don't feel guilty about doing that. It's a simple one because I think. To give a little bit of background as a second generation pole, as a son of refugee parents, they drove a work ethic.
They drove the push to do more and more. And so that drives overwork and it drives stress and it drives overwhelm. And to balance that, you need passions, you need interests, you need hobbies, you need other things that you do apart from sitting in this chair and earning money. Yeah,
Team Qualities That Matter
Adam Walker:100%.
What are the top three qualities you value most when building a team?
Passion Balance and Teamwork
Adam Baumgart:I thought quite long about this because honesty and integrity come up pretty much with every person that you've talked to. I'm not gonna mention those. That's a given in my book, it's actually passion and hopefully that's coming across today.
I'm passionate about what I do and I'm passionate about my interests, so I love it when people are passionate on the project team or the study team that I'm working in balance as well. I want to know who I'm working with. I want to know what drives you. I want to know what interests you. I want to know what constraints you've got with family, and what other interests you've got.
More than just being a name on the teams that are involved in. So balance within your life. And a simple one. But teamwork. Teamwork is essential to any team for them to function. I suppose you could call it collaboration as well. That desire to collaborate, to put the team beyond your personal interests within that organization, I think are desperately important.
Life Outside Work
Adam Walker:what is your favorite thing outside of work?
Adam Baumgart:A few things. My family. Of course cycling. I'm never happier than when I'm on a bicycle, whether a mountain bike or a road bike. I prefer mountain bikes and movies and comics. I love movies and I love comics. I'm a nerd, basically.
Adam Walker:Now I remember you set yourself a goal about comics.
Do you want to talk about that?
Adam Baumgart:So I have a ridiculous number of comics that I started collecting in 1976. So anything with superheroes in it. So my wife hates it 'cause it fills up a good proportion of our garage. I am now cataloging and making my way through those and will then get onto the process of selling as much of that as possible.
So yes, this is called Operation Cyclops based after one of my favorite comic book characters.
Adam Walker:Oh, that's brilliant.
Golden Rule and Wrap Up
Adam Walker:And finally, what is your number one golden rule in life and in business, Adam?
Adam Baumgart:So I'm gonna come back to passion. Find your passion, be passionate about it, and then forget what people think.
Adam Walker:I think that's a really lovely way to round up the conversation. We've touched on your early start in this industry and your background in applied biology and how that's been applied to risk-based quality management and that being the thing for you across all of your career you're a learner, you're an educator, and you're a lovely human being, Adam, and it's a delight to really have the opportunity to have got to know you over these last couple of years.
I only wish we'd have connected sooner and earlier in our careers. For any of our audience, if they'd like to connect with you and have the joy of getting to know you, what's the best way to get into contact with you, Adam?
Adam Baumgart:So LinkedIn is always the best route. So I've got contact details on LinkedIn feels feel free to reach out through LinkedIn through a message and I'll get back to you.
Always willing to talk to people about our BQM or working in this kind of industry. So happy to help mentor people as well. Adam, it's been an absolute joy to speak to you and you're a cool human being. Love working with you, love meeting with you, so keep on doing what you're doing.
It's great.
Adam Walker:Thank you very much Adam. Thank you for being on Pharma Prescribed today. You've been a joy as I knew you would be and you never disappoint. So keep that smile and keep doing what you are doing as well back at you and I look forward to seeing you again very soon in person.