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Preliminary insights from The Regulatory Operational Excellence & World Class RIM Study
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Welcome back to the Gens & Associates Podcast! In today's special episode, Host Katherine Yang-Iott is joined by Steve Gens and Greg Brolund to share early insights from the 2026 Regulatory Operational Excellence & World Class RIM Study.
They highlight some of the most compelling trends from this year’s data, including steady RIM performance gains, expanding regulatory remits, rising interest in AI and automation, and the debut of the new Future Readiness Indicator.
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Transcript
Introduction of Host and Research Team
00:00:06
Speaker
Hi, everyone, and welcome to the Gens and Associates podcast. I'm your host, Katherine Yang Ayat, organizational strategist, consultant, and research lead here with Gens and Associates. It's the start of 2026 and we have exciting new research to share with our community.
00:00:22
Speaker
I'm joined by the rest of my core research team, Steve Gens and Greg Broland. We, of course, are here to talk about our preliminary findings for our latest regulatory operational excellence and world classroom study.
00:00:32
Speaker
Before I continue, Steve, Greg, thanks for being here with me on this
Overview of Regulatory Study Findings
00:00:36
Speaker
episode today. Please say hello and introduce yourselves to our listeners. Thanks a lot, Catherine. Steve Gens here, i managing partner of Gens & Associates, and really excited to share, like you said, some of the initial learnings from our 40, I think it's the number 47 regulatory study.
00:00:53
Speaker
Over to you, Greg. Thanks, Steve and Catherine. So I'm happy to be here as well. This is Greg Broland, and this is one of our more exciting, I think, surveys, and so I'll be happy to share some of the preliminary results with you.
00:01:07
Speaker
Thanks so much. So yes, very exciting things to share. i think all of our research is exciting, Greg, um but I guess this one is the more exciting one because it's the new one. So this, of course, is the eighth study in our World Classroom series. And like Steve said, our 47th one that we've done as ah as our firm, we had 59 companies participate this time around.
00:01:26
Speaker
that represents a wide range of companies, which include, of course, revenue size and product portfolio. For anyone who's not familiar with our world-class RIM surveys, we measure and we track regulatory operational performance, things such as RIM capability efficiencies, metrics, data quality confidence, business benefits. We look at different organizational strategies, data governance, advanced tech application, and of course, the software provider landscape as well.
00:01:53
Speaker
So Steve, Greg, and I quote unquote owned different sections of the survey. And we just completed our internal team analysis and also our external team analysis with our group of fantastic research
Advancements in Regulatory Capabilities
00:02:06
Speaker
collaborators. So we're really eager to share what we're learning.
00:02:09
Speaker
So why don't we kick off with key takeaways from our different sections. And Steve, I'm going to start with you for the world classroom section. This is core to our research. So as the saga continues, what are we seeing today?
00:02:22
Speaker
Yeah, thanks, Catherine. So there was a lot in this to unpack. So I think the summary or the summary headline for industry is there's been a consistent incremental improvement in most of the dimensions, but there are some interesting areas where it has plateaued.
00:02:40
Speaker
ah Like you said, this is our eighth study tracking this all the way back to 2016. And it has been a story of incremental improvement. especially around our RIM capabilities. There's 15 of those. Some of the examples are the submission content management, dossier management, registration management, labeling. Again, there's 15 of those.
00:03:01
Speaker
And the efficiency continues to improve by about 10, 15%. There was a lot of investment. Going on, we estimated about $4.1 billion over the last you know five years, over 500 companies. So you would want to get some ah benefits from that.
00:03:17
Speaker
Some of the other things besides the efficiency, is the whole cost understanding. Business benefits have been going up for most, but not all. So some of those business benefits that we tracked were increased operational throughput, ah reduction of time to health authority submissions. That was one area that went up substantially, reducing operational costs, increasing user productivity.
00:03:44
Speaker
ah But there was two areas where it it plateaued, and we're not too sure why. First was it's been trending very nicely over the last six years as more and more companies reporting having key information that is real time, maybe on a dashboard.
00:03:59
Speaker
And that actually plateaued out since the last time we took the the study in early 2024.
AI and Automation in Regulatory Processes
00:04:05
Speaker
And I wouldn't say it's plateaued, but the incremental improvements slowed down ah with the data quality trending. So we're not sure what that's all about. But overall, for the picture of ah industry, it is a good picture. And we go back to the performance pyramid, and you know what you drew, I think, what, five years ago, Catherine, that the companies and our top performers that are stronger, and I know you'll go into some of this,
00:04:30
Speaker
on the organizational and the process layer, they tend to get a lot more benefits out of their systems. And there's a lot of tools out there, you know, the emerging AI productivity tools, and therefore maximizing the benefits. And since 2014, and then and again, in this year, there was no correlation between our benchmark top performers to anyone's software provider or system strategy. Again, they're just better at the process and organizational level.
00:04:58
Speaker
a layer and more and more companies, I think, are doing the KPI metrics programs. you know Those programs are maturing substantially. So there was a lot there. Overall, it's good news, but still you know some areas to really focus continually on the data quality and just getting better real-time information.
00:05:16
Speaker
Yeah, thanks. So my section is looking at, you know, exploring different regulatory organization things, right? We look at a couple of new questions this time around, which includes the status of their process maturity, their change management capability. And of course, we always look at things like the culture, strategic initiatives and things like that in my section.
00:05:35
Speaker
And, you know, sort of just continuing on what you were just saying, over the past few years, we've had a lot of conversations about how regulatory organizations are evolving.
00:05:45
Speaker
And I think what we're seeing with all of these past incremental changes, right, what you're seeing across all of the other world-class REM elements is that they're adding up to a major shift for regulatory organizations. And so the exciting story that stood out for our team is that we're seeing that the majority of regulatory organizations really have all of a sudden this willingness to explore new technologies. They want to be tech forward. They're viewing change management as an essential organizational capability.
00:06:14
Speaker
And this is a significant culture shift from just not too long ago. i think for me, the learning bit here that we see in our data is that though a lot of companies are really embracing change management for things like systems and technology changes, they often fall short on applying that same change management approach for things like process-related work or data-related initiatives. And I see that as a mistake because ultimately that's going to undermine all the effort they've put into the system or tech investment.
Future Readiness and Technology Adoption
00:06:42
Speaker
I almost see change management as is this mindset to have to ensure the continuation of progress. And like you said, incremental changes year after year when we're doing these studies, you know, if you look over at like three, four years, four, five years, five, six years, all of a sudden that's sort of significant change.
00:06:57
Speaker
And I think we're starting to see that story kind of come to life a little bit. The other piece of data, which I know we're sort of just highlighting things that are the major key takeaways from our studies. So for those who want to, you know, obviously learn more about our data and see the question by question results, we'll have that in a few weeks.
00:07:13
Speaker
But um the data also shows the remit of regulatory is widening quite a bit, right? So one of the questions that we've tracked is looking at regulatory functions and sort of their reporting structure.
00:07:25
Speaker
This time around, we measure 16 different functions in the survey. And I think all but one is currently a function within regulatory organizations and over 50% of the responses. Just as sort of like ah a comparison, right? If you compare like a single data point and I'll just use like regulatory business excellence or continuous improvement as an example, 90% of our respondents say that this is a function within regulatory today compared to only 38% back in So you can see that there's a big shift in all of these different functions that are part of regulatory organizations today that perhaps warrants a few years back.
00:08:01
Speaker
um Greg, what about you? Any sort of key takeaways you want to share here? yeah So thanks, Catherine. So I've been focusing on the technology solutions and some of the advanced automation capabilities for regulatory.
00:08:15
Speaker
And for me, there are four key takeaways from this area, automation solutions. First, there's a lot of interest in data aggregation platforms. We've been testing this for a number of years, but the use of this kind of platform is, in fact, increasing. For example, 66% of the companies in the survey have already completed the implementation or are investing to a significant degree in these and these platforms.
00:08:42
Speaker
The second area is the set of artificial intelligence enabled advanced automation use cases. So we've been testing a set of fairly common in use cases for a couple of different cycles.
00:08:56
Speaker
And there are two sets of these use cases with the highest level of interest. The first is automating collection and the use of regulatory intelligence to support various regulatory activities.
00:09:08
Speaker
The use of regulatory intelligence has been an unmet need for a number of years now. So this is the area of high interest and seems to be fairly promising. The second is the ability to analyze and produce insights from company's history of interactions with health authorities.
00:09:29
Speaker
And this is typically used to inform the next answer and make sure that the answers are consistent to additional health authority interact questions and provide a really good set and of answers and it will help provide the basis for those answers.
00:09:47
Speaker
The third area is the use of AI for content generation, especially for clinical documents and document translations. For example, 60% of the companies expect to have some level of content generation of clinical documents in place by the end of this year, 2026. The fourth area is the use of cloud-based collaboration platforms for interactions with health authorities and industry partners.
Understanding Process Maturity Gaps
00:10:16
Speaker
We see this becoming a dynamic collaboration space with new ways of working, including new processes for sharing with industry partners and with health authorities. Almost half the companies in the survey plan to be involved in an initiative in the next year, and 70% believe that using a cloud-based regulatory space will innovate the way they work with regulatory within the next five years.
00:10:44
Speaker
So that's the good news. On the other side of the coin is that there has been a limited experience with AI so far. For the AI advanced automation use cases, 47% of the companies have pilots or implementations, but only 19% report benefit realization.
00:11:06
Speaker
And the experience is even more limited with content generation use cases. 28% have pilots or implementations, but only 9% are reporting quantifiable efficiency gains.
00:11:19
Speaker
Yeah, I think that the AI conversation is interesting, right? You just gave us a bunch of data. And I know we did an AI automation survey not too long ago, right, that can support some of the learnings that we're learning from our data in this study.
00:11:34
Speaker
So what does it mean, right, for regulatory organizations in this environment, like what we're learning, the insights and our interpretations? Can you say a little bit more about that, Greg? Yeah, so it is interesting, right? The combination of that earlier survey, the advanced automation survey in early 2025, I believe, and our experience in talking to our clients sort of inform what's going on and what the what it means for regulatory organizations.
00:12:04
Speaker
So many regulatory organizations are being asked by senior leadership to increase operational efficiency, for example. Increased efficiency was the number one primary benefit that was expected from implementation of the advanced automation use cases in this survey.
00:12:23
Speaker
Senior leadership often expects AI and other advanced automation to produce significant improvements and to produce those improvements relatively quickly. And there are success stories being reported.
00:12:36
Speaker
However, many companies are learning that they need to invest in foundational improvements and processes, data quality and governance, as well as technology. And making investments in all of these areas will help regulatory organizations achieve the expected benefits of technology.
00:12:55
Speaker
But it will take some time, maybe more time than some of the senior leadership expects. So that's a little bit of a dilemma. For example, a year ago, most companies expected to have at least some of their advanced automation use cases in production in the 2026-2027 timeframe.
00:13:15
Speaker
In this survey, we see that expectation has moved for most companies to the 2027-2028 timeframe. So this is definitely an area that's a work in progress for regulatory organizations.
00:13:30
Speaker
Yeah, actually, you bring up a couple of good points. where I think the timing element is important, right? I think people often underestimate the amount of time it takes to really become competent or familiar or comfortable with using new technology. So I think that's what you're saying about making sure that organizations are also investing in the foundation of elements is really important, which kind of brings me to this future readiness indicator that we've created for the first time in this study.
00:13:55
Speaker
So in our studies, usually we have the world-class room rating, which tells companies where they stand
Organizational Challenges in AI Adoption
00:14:00
Speaker
in terms of their overall operational performance in comparison to their peers. But we've also looked started to score other elements that we've been talking to companies about over the years, such as data governance, process maturity, organizational elements, dimensions, such as culture, change management, et cetera.
00:14:17
Speaker
and um digital maturity. And we've sort of combined that into a future readiness indicator because, you know, like you're saying, overall in terms of operational performance, as efficiencies are trending upwards, performance continues to improve, but are companies preparing for what's next?
00:14:34
Speaker
And, you know, as they're preparing for what's next, which is often these ah advanced ah automation, AI technology integrations, they have to make sure that they are really working on the change management in part, the process part, to make sure that they're able to successfully move forward with whatever new technology that they're integrating.
00:14:52
Speaker
Steve, I don't know if you want to say some more about this. I know we've we've been having a lot of conversations the team about the combination of these two scores, right? Almost one being a leading indicator, one being lagging indicator of where you perform today and your readiness for tomorrow.
00:15:07
Speaker
Yeah, Catherine. And, you know, it's something I know it it took us about six months to figure out, like, how do we calculate the future readiness indicator? But it's really, really critical, you know, because it is about the future.
00:15:18
Speaker
People talk about both agility from an organizational standpoint and also a technology. But we're truly in a transition period where. Kind of our old, more manual, fragmented systems that we used to, and we just, you know, a lot of companies paid a lot of money to modernize their systems, streamline their processes. There's a lot of skill up, especially for AI and data literacy that we're going into fully into the digital age.
00:15:46
Speaker
But we're not quite there. And I think the FRI measure that very well as far as you know different organizational strategies that people have to consider, like with the advent of AI and the potential disruption, you know how do we do workforce development, especially with junior ah resources?
00:16:05
Speaker
that everybody, and there was a big generational conversation about AI skills and data literacy, that it's all about the data. We've been used to documents, documents, documents in regulatory for a very long time. So there was a big transition period that we're going through.
00:16:21
Speaker
So there's new skills, new roles, new methods, tools, and you know that some of the stuff we look at is the behaviors too. Is it a quality mindset? Is that rewarded regulatory?
00:16:32
Speaker
So there's a lot of things coming together at the same time for most ah regulatory organizations. So it's actually a really, really exciting time, but there's a lot of work to be done besides doing regulatory strategy and getting those submissions out the door.
00:16:47
Speaker
Yeah, absolutely. i mean, everything you're talking about right now is really sort of describing the the Bridges transition model, right, which is a change management framework that we use quite a bit. And I almost see this FRI, this view charting, this indicator score as, you know, as you're going through that transition period, how you spin out of it, right? So, you know, all the things in the transition period that you need to be working on are foundational to the success of of what the new way is going to be.
00:17:12
Speaker
and making sure that you're considering all the right things and doing all the right things. If your FRI score is higher, then it can help you really sort of envision when you transition out of that stage, you know, where you will be in terms of the new way. So again, I think some interesting tools and customized data for the people who participated in our study this time around that you can look forward to.
00:17:34
Speaker
I don't want to miss any other sections of the study, the key takeaways. Steve, did I miss anything? I know that we each kind of went through our sections, but... But there was structured content. There's an authoring section that I want to make sure that we sort of hit on as well if we need to.
00:17:47
Speaker
Yeah, I think just the highlight there is on there was two other sections. I know Greg touched on it a little bit. And the reason for the new section on the authoring, authoring really hasn't changed in 25 years. We have our style guides, our document management systems, templates and all that. But with generative AI, it's really a game changer.
00:18:07
Speaker
And everybody's working on their clinical documents to a lesser degree, safety labeling. There's emergence of CMC documents. That's very, very clear. But i I think the biggest, and I wouldn't call it a surprise because I know, Greg, we've been tracking it in different ways for probably 15 years. But the biggest pickup has been in the translation. So we think about the
Advancements in Translation Automation
00:18:29
Speaker
authoring process. We have ah authoring of the content.
00:18:32
Speaker
The review process, you know, that if you look at it from a non-tech, there's great opportunities to streamline that. And then the automation of translations would save a tremendous amount of cost and time.
00:18:44
Speaker
So we are, in some ways, we have baseline data, kind of how we framed it from like, you know, standard initial automation and advanced automation. So the advanced automation is about two or three years out, but there's a substantial effort going into it, and we really think it's going to break through. And Greg, I don't know if you have any additional comments on that. I tried to really quickly highlight that one section.
00:19:07
Speaker
No, I think you're right. And it's interesting that the translation use case is one of the most advanced in terms of actual implementation and of interest.
00:19:17
Speaker
As you pointed out, people have been working on some kind of automation for translations for many years, more than 20 years. so this sort of evolving technology around AI may make that much more feasible and economical for technical documentation that regulatory have to translate for local health authorities. So at the I think that's a pretty exciting area of development.
00:19:47
Speaker
Steve, just kind of mentioned some surprising things for you um in your last comment, but are there any other sort of surprising things that came up for you in your other sections, especially the world-class room? Yeah, I actually was in the the organizational section, Catherine. Don't take away my surprise.
00:20:03
Speaker
ah Well, we might have a similar surprise and like, what did it mean? So um yeah, I was really excited for the first time ever, we quantify process maturity. And when we looked at all the data, it's like, yeah, level one through level five, it's what I would expect. And for our listeners, we have a maturity model. There's five levels. It's based off a CMMI. So level one is initiating ad hoc processes. Level two is repeatable, but not repeatable throughout the organization, but you're starting to get basic process established.
00:20:35
Speaker
Level three, you have controls, s SOPs, work instructions, you know, training, it's well-defined, it would pass an audit. But then you get into more the advanced, the level of four and five, you're introducing quality performance metrics.
00:20:48
Speaker
You'll have data-driven continuous improvement, which leads to optimization, so level four is measuring. Level five is optimizing. So when we looked at the chart for everybody, it's like, yeah, kind of what I would expect. But when we did that top performer versus everybody else, top performers, there was 10 and everybody else, there was
Connecting Change Management to Process Maturity
00:21:07
Speaker
49. So that's how we get to the 59.
00:21:10
Speaker
And the top performer gap to everybody else was very substantial explanation point. It actually really, really surprised me. So our top performers in some of the regulatory processes, there was nine.
00:21:23
Speaker
The major marketing submission, health authority commitments, health authority interactions, the whole Q&A process, product registration, label management, kind of the list goes on.
00:21:34
Speaker
In a couple of categories, all top performers are a level four and five, and for most all others, nine out of 10 were at level four or five. But when we look at even something like, and I'll pick on the health authority commitment management, all top performers were level four or five, but only 38%.
00:21:53
Speaker
Of everybody else, the 49 companies were at level four or five, and some were at level one or two. So there was a lot of compliance risk there. So that that was really surprising. And the other one, too, where there's such a high volume of work, and that process gets worked hard every day in every biopharmaceutical company on the planet.
00:22:13
Speaker
and that tech company on the planet is the regulatory impacts assessment for change control. Whereas eight out of 10 top performers, they're in the level four or five. So they're optimizing. They're trying to reduce the cycle time, and ensure quality.
00:22:27
Speaker
It's highly measured. Whereas only 36% of everybody else. And we know, and we proved out that a data-driven, metric-driven continuous improvement and improves performance over time. It's not the big bang, you know, system project or ai is going to solve everything.
00:22:45
Speaker
It's that foundational business discipline. So yeah, I was really surprised, but then there was an opportunity, right? And I think we were left with curiosity and a question. It's like, why is there such a significant gap? Is there a gap in regulatory as far as expertise and process management?
00:23:05
Speaker
And as our one colleague Priya would say, not being able to connect the dots between roles, processes, and systems. So I think we are left with some curiosity. Why was there such a substantial gap?
00:23:17
Speaker
But these gaps can be closed on the process level. Maybe there's too much focus on the system and data and not enough with the process because they all go hand in hand. So that was the big one for me, Catherine. Yeah, actually, you know what? You and I have slightly different views, I guess. My my biggest surprise was also about the process maturity, but more so that it was better than I thought it was going to be, right? So when I talked about the future readiness indicator where there's four dimensions that we're really scoring, right? Process maturity being one of them.
00:23:44
Speaker
But then we break the four dimensions out so that companies can tell which of those four dimensions are they highest or lowest in. And then when you look across most companies, I would say that in terms of the FRI, their process of maturity is always almost always the highest compared to some of the other things, such as the organizational agility, alignment, data governance, or the digital strategy maturity.
00:24:07
Speaker
And I know in Greg, in your section, there was a question about the obstacles right that people had for, ah remind me again what the um what the category was. Yeah, it was the obstacles for adoption of some of these AI use cases and advanced technology in general were the primary obstacles. Yes, and it was like mostly like organizational things, right like the cultural, the mindset sort of behaviors that sort of ranked kind of higher as a major obstacle for them.
Conclusion: Evolution of Regulatory Practices
00:24:33
Speaker
So I think, you know, for me, I was really encouraged to see that change management is at the top of lots of companies' minds as a capability in their organization that can be improved on.
00:24:46
Speaker
I think, you know, if we go back to Priya's note about connecting the dots, I think a lot of times companies still focus on their change management capability on systems and tools and not enough on the organizational changes, the sort of process, related things. And I think if they can figure out how to apply the same change management approaches to those, then I think that's ah that's more of a winning combination. So Greg, do you have any surprises?
00:25:11
Speaker
Yeah, yeah. So, you know, they're not necessarily in the area of these sort of new and evolving technologies. The two surprises that come to mind for me are areas that have been around for a while, but it looks like they're finally coming to fruition, right? The first is that I'm pleasantly surprised by the enthusiasm for cloud-based regulatory spaces, such as Accumulus and DNA Nexus in other areas.
00:25:39
Speaker
Similar efforts over the last 20 and maybe even more years have really not been commercially successful or adopted across the industry.
00:25:50
Speaker
But the level of interest and expectation for realizing positive benefits for this iteration of information sharing via the cloud, both for, as I mentioned earlier, for industry partners in with regulatory health authorities, indicate that this might be the right time for this solution.
00:26:09
Speaker
The second area, and an area, again, that we've been monitoring for quite some time, is what we're calling the data aggregation platform. And this includes so what used to be data warehouses, data mards, data fabrics, all all those things. But as a group, both large and mid-tier companies report significant implementations of data aggregation platform.
00:26:31
Speaker
So, for example, implementations of the top two use cases amongst large and mid-tier companies are that 72% plan to use or do use these platforms to generate dashboards and reports, and are typically cross-functional.
00:26:48
Speaker
And 62% specifically use them to enable insights and reporting and cross-functional visibility. So again, these are two technologies and solutions that have been around for a while, but they really seem to be gaining traction within companies.
00:27:04
Speaker
Yeah, thanks so much. I mean, I think, you know, what we're saying here is that basically the evolution of regulatory organizations, you know, is happening and we're in a new era. And it'll be really interesting to see how all the practices and the interest today drives the future vision of what regulatory organizations become in five or six years or less.
00:27:25
Speaker
So before I close this out, is there anything that I forgot to talk about? um Steve, Greg, any sort of closing comments before I say goodbye to everyone? All good here, Catherine. It was such an extensive study, and I think we hit some of the key points on it. And like other large studies like this, as we start the private debriefs you know with the different participants, they ask great questions. We do a little bit of more analysis, more learning, and you know but i think... now This is a really good chat about kind of the initial impressions.
00:27:57
Speaker
ah So all all good here. How about you, Greg? I agree, Stephen. i guess it's just sort of stay tuned, right? These are some of the highlights that come to mind as we're in our sort of final phases of the first seven results, ah but more will evolve and be available in the future. So stay tuned.
00:28:15
Speaker
Thanks, Greg. Thanks, Steve. Listeners, thanks so much for tuning in Like you heard, we have lots more learnings to share with you as we're talking to people in our research community. If you've heard something today that you want to explore more on or simply have questions for us, feel free to reach out to any member of our team and we'll be happy to connect with you. Until next time. Cheers.