Maximizing the Power of Central IRBs Prior to the FDA’s sIRB Mandate

Get ahead of the impending single Institutional Review Board (sIRB) mandate and optimize your clinical trials by tuning into this recorded webinar.

About the Webinar 

The Food and Drug Administration’s (FDA) impending sIRB mandate will streamline processes by requiring multi-site studies to partner with one IRB reviewer. While the date is not set on when this mandate will go into effect, it is crucial to prepare your studies and processes now. Fortunately, in our recorded webinar, WCG’s experts share insights on how to best prepare for the sIRB mandate and the critical role of site selection. Understanding the process of identifying the right sites is essential for the success of your clinical trials. This webinar is most relevant to anyone conducting or managing multi-site research. 

WCG’s expert panelists cover: 

• An overview of the impending sIRB mandate. 

• Strategies for streamlining clinical trial processes to meet the new requirements. 

• The critical role of site selection, including best practices for identifying and preparing sites. 

• Proactive steps to take now to ensure a smooth transition to an sIRB process. 

Full Transcript

Kate Schroeder: 

Hello, everyone. My name is Kate Schroeder, and I am a marketing manager here at WCG. And I would like to welcome you all to today’s webinar, Maximizing the Power of Central IRBs Prior to the FDA’s SIRB Mandate. 

As a reminder, if you would like to ask our question or any questions to our speakers, you can do so by clicking the Q and A icon located at the bottom of your screen. In addition to pre-submitting questions we’ve gotten from audience members, the panel will spend some time going over live questions that you submit today as well. I’m excited to be joined by our WCG experts, Matthew Staves, who is the senior vice president of operations for WCG’s review solutions, and Cristin MacDonald, vice president of client delivery at WCG. And with that, I will hand it over to Matt. 

Matt Staves: 

Wonderful. Thanks, Kate. Well, good morning, everyone. Thank you so much for joining us for today’s webinar here. I’m Matt Staves. I run operations for our review solutions division, and that includes our IRB. So just like tale of two cities, today, we have a webinar in two parts. So the first part we’ll talk through is gonna be around the regulations so we understand them so we know what is upcoming and, most importantly, what that means for us. And the second part is, so what do you do about it? What can we do about it now to be prepared to get the benefits, where that will deliver benefits for us, as well as how do we take those steps now so when it does go into effect, that it’s seamless and smooth? 

So let’s take a look at this one. So first one, there’s an acronym you’re gonna see today, NPRM. That stands for notice to proposed rulemaking. And this is that FDA document coming out there, with changes to the regulations. So there’s two of them coming up, and they are separate and distinct. And I wanted to talk a little bit about both of them today. That way you understand what is covered in each one of those since they don’t necessarily have to move on that same timeline. It’s good to know which elements reside in which of those notice of proceed proposed rule makings. 

So the first one, and the main one we’re gonna talk about today is gonna be the one associated with cooperative research. That’s the single IRB right requirement one. And the second one is on the protection of human subjects and institutional review boards, and that one’s gonna be more focused on the informed consent, process.  

So starting with that. So the first one of these, the cooperative research one, as we mentioned, this is the main topic of today’s discussion, that single IRB piece. So when we look at that one, a key thing for us to understand, as a framework for this is the common rule. Now the common rule is what’s out there regarding informed consent in IRB, and it’s been widely adopted that there’s sixteen agencies at this point that are operating under the common rule, most recently updated back in twenty eighteen. And a lot of what this this, these notice of proposed rulemaking changes are harmonizing FDA requirements with the common rule. So many of the major research funding coming from places like, health and human services, NIH, Department of Defense, many VA, many, many others, these are operating under the common rule right now, aimed at streamlining that research, to reduce the regulatory burden by having, just like the name says, something that’s common. So when you are building your proposals, when building the proposal for research, that it’s under a common framework to the greatest extent possible. So with that one, the basis of this, is back in the 21^st Century Cures Act in 2016. Congress directed the FDA to take the action to harmonize, where possible, and there will be exceptions, which we’ll talk about, with that common rule. Again, aimed at simplifying that regulatory burden on-site sponsor CROs here. And the FDA came out with their proposal for this back in September of 2022. Now it doesn’t have a defined timeline. We expect it to probably be sometime in the middle of next year, but it’s not set in stone just yet on when that will happen there. And, again, there is one more of these NPRMs going on right now, and they’re separate and distinct. So just because one goes forward and happens at a certain time doesn’t necessarily mean that timeline, is the exact same for the other one here. So keep that separation in your mind as we think through single IRB. 

So the single IRB requirement there. So, I’m gonna read this one through so you get it in the words themselves. To streamline the IRB review process and decrease administrative burdens and inefficiencies for investigators and IRBs without compromising human subject protection. So one of the key or really the key element is this makes single IRBs required. If you have a multisite study, and, again, this is specific to the portion of the research the United States. It excludes the ex US sites. Those need to go through a single IRB now, or will once that notice of perceived rulemaking is adopted. 

So the difference from today is today, you certainly can do this. We recommend you do this, and we’ll talk about ways to get the benefit of that in a little bit. But this will change it to where it becomes a regulatory requirement that it’s not an option. It’s simply the way that research needs to be done. So with that, again, that makes that key point. If you’re a sponsor CRO, you’re going to be required to use that single IRB once that rulemaking goes into effect. And if you’re an institution or investigator, that really means you are following the guidance of your sponsor or CRO on which IRB they’ve selected for their trial in using that one. Right now, where there’s that option of, yes, they’re preferring this one, but we’re going to go with the separate one or with the local, that won’t exist anymore for multisite, studies with a few small exceptions, and they’ll be most likely pretty uncommon exceptions, and we’ll talk about those in a second here. 

So the exceptions one. So I mentioned earlier, there’s a few areas where it’s going to be some difference still from the common rule and this new notice to, proposed rulemaking. And the exception one is an area where there’ll be some small differences here. So under the common rule right now, two exceptions are called out. 

The first one is gonna be there are areas where, more than one IRB is required by law. Perfect example of that, is if the governing body is, tribal. That would be one where, it’s an exception that it would still need to use that lawfully required IRB for the research. And on the second side of things, that they have a small carve out where those federal departments have the ability to determine, in this case, it’s not appropriate to use just one IRB, and they could allow for a multi IRB review of it. Again, not super common, not the norm, but those are the two exceptions that that did exist or do exist under the common rule. 

So what does that look like? What does the FDA propose? And this is one where there’s some amount of differences here. So the FDA, proposal had called out four different categories. The first one, very similar, just like we saw in the common rule, for ones where the law requires a certain, local IRB or, like, tribal IRB to do that review. The second call out, the third call out there are highly specialized ones. The first being if there’s a geographic element where that localized expertise is necessary for that medical product, that in that case, there is an exemption for it. And then and then they allow for exemptions under a few criteria for, drugs that meet certain exemptions as well as medical devices. These are primarily aimed, at things that are, either phase four or investigator led studies, which very frequently are going through just one IRB anyways. So, again, it’s the exception, not the norm. 

And as you can see, there was a couple small differences, in what those requirements were. The most important one of those, is not adopting that ability for federal departments or agencies, to grant exceptions. And if you’re the FDA, this makes sense. The FDA isn’t a funding agency, that the other ones operating under the common rule, are. And so it makes sense for them to give themselves the ability to grant their exemptions. FDA being different makes sense that it does not.  

So, as we talked about those exemptions, they’re fairly specialized. They’ve got the local expertise, and then they’ve got the ones that really are going to be where it would be mostly small studies, those investor initiated research, as well as, the phase four trials there. So the second one. So that’s the single IRB one.  

Let’s talk about the second one so, all of us are aware of what’s in that, and we can take a look at what the changes are to the consent requirements. So this one, very similar here. It’s oh, my slide jumped around on me. Do that one more time. There we go.  

So very similar to the last one where the 21^st Century Cures Act, that went into law back in 2016, required the FDA to work towards harmonizing with that common rule again. So, again, separate and distinct. They can go through on different timelines. This one, is aimed at FDA’s regulations around informed consent, for IRBs. And I’ll read through this one here, as it’s gonna have a key information section, of the informed consent process that gets called out. That becomes now a requirement in what the IRBs will be reviewing in these forms. So the prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate and an opportunity to discuss that information. So makes sense. Right? It’s you want people to understand what they’re getting into. And as research gets more and more complex, it ends up being critical for us to translate that into formats that are understandable for subjects. And that really is the intent of this notice of perceived rulemaking, harmonizing with that common rule, adding this key information for subjects, to go through in the informed consent process.  

So it has a couple elements then of requirements. The first is a concis and focused presentation of key information, aimed at helping them make their decision on if they wanna proceed with that research. And it’s aimed at facilitating comprehension, taking that which is complex and turning it into something that the average person can digest. And the second is the presentation of that it’s not simply a list, not just simply a bundle of facts, but translates that through to here’s what that means for you, if you proceed with being part of this study. So those are the two elements now that are gonna be or the element that key information element that’ll be required to be included in the informed consent process. And so that will have impacts on those who are drafting their informed consents as well as the IRBs who are reviewing those. So a couple examples here is translating things into digestible manners. If you do the study, x might happen. If you do the study, you will need to do y, of making that, concise and clear to the average participant.  

So what does that mean for you? What does that mean for all of us here? So, of a lot of studies or individuals who are working right now with federally funded studies, they’re used to that. Since this is in the common rule, this is simply FDA harmonizing with that common rule. So if you’re familiar with the requirements in those federally funded studies, you’re in great shape. You’re gonna be, well ahead of the game when this one, does get adopted. Because, really, the key is making sure that key information section, is there at the start of the consent form. And so then for those of us in the IRBs, that’s one more element that we’ll be reviewing for in there, making sure that key information section’s there and in line, with the proposed rulemaking. 

So with that, we’ve talked through the two, regulations that are pending/upcoming. So let’s talk a little bit more about so what do you do about it? So the first one, let’s start with the current IRB landscape. It’s a little bit messy, as the title says here. That very frequently, you’ll find yourself working with multiple central IRBs and local IRBs when doing multisite trials, because right now the sites have the option to go to the IRB of their preference. And that is the key piece that’s gonna change when it moves to, single IRB. 

So along with that comes concerning challenges in in the current landscape. So the way I always think of this is if I’m going to the grocery store to buy five apples. I show up at the grocery store and they say, well, here’s two apples, and here’s an orange, and here’s a sack of flour, and here’s a potted plant. You get a little bit of everything different, and it’s not consistent, across. Say, for example, one of the IRBs wanted language, present in the informed consent and another didn’t have that requirement. Now it’s getting a little bit messy. Again, each of these different IRBs involved is gonna have to be reviewing the protocol. 

Another area that will add time, to the process, as well as that, again, that possibility for divergence, for lack of consistency, across the research you’re doing at the end of the day. So right now, it’s a system with the ability to be improved, and that regulation really is aimed at solving those key challenges. For those of you who are sponsors and CROs, that comes with benefits. You you’ll end up with a faster review. Since it’s all done in one place, now you don’t have a series of step processes or one slowest, review in the group holding up the rest of it, as well as you get that consistency that it’s reviewed in one place. There your research is being looked at holistically, and so you get a better review at the end of the day. 

So, at this point, wait. This is what we do as WCG. We are a central IRB. We have 3,600 or more, hospitals, research centers, universities we work with, over 300,000 sites that we’ve worked within the last 20 years. This is what we do, and this is really how we built our IRB, based on these partnerships with many, many, many, many sites out there. Whether you know it or not, you probably work with us because many of the sites, are working with us right now. And we’re used to working with sites in the very different requirements that they can have one to the other. We have a team who’s sole purpose is to make the lives of our sites, our institutions easier, to be able to help them through that process of managing their IRB review. And the net result of that you get through the review process with the highest possible quality in an expedited manner. It’s a 30% reduction in study startup by using that centralized IRB review process with us here at WCG.  

And so what does that then look like for single IRB? So for single IRB then, it’s simply funneling all of those through us here at WCG. Now you’re dealing with one group, one person, rather than going to the store and getting a few of which you thought you were gonna get and a couple surprises along the way. The key one here is this will become regulation, presumably sometime in the middle of next year. So we’ll be required to use, single IRB, but there’s no reason to wait. There’s no reason you can’t do that now and get the benefits of it right now, that consistency, that speed of review. And the way to do that is if you’re the sponsor/CRO, be in the driver’s seat. 

Simply say, this is the IRB we’ve selected, and we need everyone to follow that guidance, use the IRB selected. You get the benefits for it now as well as that’s what we’ll need to do when that becomes law. So you’re getting the chance to practice along the way and be prepared for what’s upcoming.  

So at this point, let me hand it over to my friend, Crissy, and she can talk a little bit about ensuring that seamless transition. 

Cristin MacDonald 

Thanks. I appreciate it, Matt. Yeah. I think the biggest thing here is that, really the hope of that guidance is that there is that single point of oversight to streamline the process, but as we know, usually we’re intending to streamline processes because we want to make things faster. Right? And as he said, there’s ways to lean in to that and what’s being done today. And I think, it’s helpful for sponsors and CROs as he just stated to kind of understand the regulations and their requirements. But really the biggest impact of this is going to be not only your submission processes, but also how you’re selecting sites that are meeting our objectives. Right? 

When we’re selecting sites, we’re frequently dealing with that PM triad. Right? We’re looking at speed, we’re looking at cost, we’re looking at quality, and we have to balance kindof all of those throttles when we’re doing our site selection so that we have a mix of those fast sites, those maybe slower sites if it’s an academic center and whatnot, but high quality that comes along with those and we have to kind of mix and match those levers to come up with our core objectives and meet those timelines that we’re talking about. 

So really when we look at this, it’s tying together some niche data points that we maybe have been collecting before when you’re doing your feasibility process and saying, oh, what type of IRB do you use? Except now almost everyone’s gonna be checking that central IRB process when this comes to play. Right? 

So we have to take all of that nuanced data in a very particular way. As you know, WCG provides many niche services to the industry. Most of those are kind of posted on this slide here for you to take a glance at. But what happens with that is that we actually have a very unique dataset that when analyzed the right way can really help support decisions like what sites to select to start up more rapidly, to have maybe higher quality data entry, and ultimately that are going to be able to enroll patients particular for your trial. Right? 

One of the examples that I like to bring up when we look at this slide of things that don’t seem all that connected in terms of site identification, but that when you look a little bit deeper in terms from a layer standpoint you can kind of understand how they connect, right? So if we’re looking to identify sites for perhaps a CNS study and we really want to make sure that they start up rapidly, at WCG we can kind of triangulate not only the experience and the historical performance of an investigator, but we can also tie that to the number of trained raters that they have in it, at that institution adding now into whether or not they’re utilizing exclusively a central IRB, tied also with those contract and budgeting cycle times really to highlight the best institutions that have demonstrated that high quality, high performance, and rapid start up timelines. 

And frankly, we’re able to do that through the power of what we call ClinSphere at WCG. And that’s the platform that the WCG applications are run on. 

So with all of the technologies from those services that you saw on the previous slide, it allows us to gather that really deep and nuanced data intelligence. So our WCG proprietary data paired with publicly available data to kind of fill in some of those gaps and ultimately some licensed data gives us information for over a 160,000 global investigators. When we partner that with the fact that we have 95% of industry sponsored protocols and then those relationships that Matt talked about with our institutions and academic centers, as well as the patient advocacy groups really to give input on all of those protocols. Those insights and expertise are really what help to ensure that that most important decision of your clinical trial are made with that deepest set of data that’s available within the in the industry. 

So when we work here at WCG with sponsors to balance that speed, time, quality triad of their site selection, we support them in a couple of different ways. Firstly, through those clinical development insights where we’re helping really understand the landscape of what’s the competitive nature across the industry of the indication of the type of molecule, of the type of, comparative that you’re doing to find out what are the best countries to conduct that clinical trial and who ultimately are you competing against. 

We take that information and move it into the site identification phase where we help find investigators that have experienced ultimately in the very nuanced component of the clinical trial that you as a sponsor or CRO are running. Right? 

We might need to look at lupus trials, but if I look at lupus trials that are done through a traditional, mechanism of treatment, it’s very different than finding investigators who are looking at cell and gene therapies for a lupus trial. Right? 

So we’re looking at those, matching and understanding the enrollment rates and the investigative experience with the very nuanced component of the trial beyond just the indication level. But when we do that site identification, we’re not just looking at the investigators and their performance both in terms of enrollment and speed, we’re also looking deep down at what is the competitive landscape at that particular site. 

So how many other active trials do they have enrolling and then even double clicking a step further to understand of those trials that are competitive and actively enrolling at that site right now, where does my protocol fit in that is it truly competitive beyond just the therapeutic area or are there eligibility criteria or compensation that differs that may make my protocol more or less desirable? 

And that’s some of the insights that we pull in there, as well as, you know, are there trained raters if it’s a CNS type of study that we talked about earlier, are they utilizing a central IRB, what does that process look like?  

And last but certainly not least because I think this is where a lot of that single IRB information is gonna come into play. I see a lot of questions about how that’s gonna play out at academic centers and whatnot. But there’s the feasibility process, right, which is really some of the most nuanced feedback on a sponsor protocol on what their internal processes look like, and we support sponsors through that in this feasibility service where it’s either white glove and we are doing all of the outreach on behalf of that sponsor or the CRO, or it’s a self serve manner where you’re utilizing the technology on your own to do that outreach and really look and evaluate, the landscape of the investigators that you’ve invited to participate. 

But when we support sponsors in identifying these sites again we can focus on selecting only sites that are utilizing that central IRB and ultimately even confirming that that’s the case in the feasibility steps, which I think is what we’re gonna see as we move forward because, we got these questions in registration, I keep seeing them pop up now, but ultimately just because the single IRB mandate means that everyone has to use a central IRB. That is true, but it does not necessarily mean that they’re gonna change their internal processes.  

So if we look at an academic center, there are some indications that they’re still going to continue their internal IRB review process and then submit to that central IRB once that internal review is completed. If you are here and you are from an academic institution, we’d love your comments in the chat of what that discussion has looked like for you and your teams internally. But ultimately for us when we’re evaluating how we’re anticipating this gets applied, what that means is when we look at WCG’s KMR benchmarking data, this is looking specifically at oncology trials across the tool. We see that median startup timelines for local IRBs from submission to approval is 27 days. For a central IRB that median timeline is 11 days, so what we expect to potentially see happen is that those two timelines would end up having almost a dependent relationship on a Gantt chart. 

So that IRB approval at that local level or that academic institution is likely to occur first prior to the submission to that central board, which is going to potentially increase some timelines. So we do have to really think about that and why that’s so important to understand those nuances when we’re doing site identification and feasibility, because ultimately we’re gonna find that out altogether as we begin to start up those trials under this new ruling. And it’s not to say that we wouldn’t utilize those, but we’re gonna have to plan for that information when we’re doing our enrollment modeling and planning our timelines for those studies. 

But the question is, you know, how do we learn this together as an industry? And I think this is where the feasibility component ties in. 

And the first step is to sort of standardize how we’re collecting feasibility data. I’m sure everybody has probably seen at this point in time, but ASCO did an amazing, journal article not too long ago that just talks about the inefficiency of that traditional site feasibility process, which you see on the left hand side, which is fundamentally that every one of us on this phone call that represents a sponsor or a CRO has probably gone out and asked the site likely not once but multiple times whether they utilize a central IRB. Right? 

So WCG’s total feasibility process is really meant to reduce that burden and redundancy that comes with the feasibility process, ultimately by standardizing how we’re collecting that data. So that Total Feasibility application sits on ClinSphere. So it’s doing a lot of what that central IRB mandate’s doing in terms of simplifying and standardizing that process under one umbrella, where there’s a central repository that sponsors can access the answers to those standard questions and a site ultimately only has to answer those once. 

And how that relates here is that really it’s a rising tide lifts all boats scenario where we as an industry can work on moving faster together by really understanding an individual site’s IRB process once one person asks them the first time. And we don’t have to keep going back and back because anyone who utilizes the, Total Feasibility platform can see the answers to those standard questions related to an investigator and the facility that he or she works with. 

But so what does that look like? As I said, it’s an expanded site profile, it’s fundamentally based on WCG site network profile and it has been broadened, but it’s a comprehensive view of site capabilities and just staff logistics, etcetera, logistics in terms of how do they get referrals, how do they submit their IRB, contracting and budgeting processes, etcetera. 

As I said there’s that standardized question bank that allows that 100% of data usability, and then there’s a piece that is customizable by sponsors that doesn’t require data mapping, right?  

So ultimately what happens is you can add or subtract questions from that standardized question bank, but added questions that are truly protocol specific, would not be part of that process. But then ultimately there’s enhanced outreach and reporting because the way I describe it is much like we all get an email from our credit card company once a year just saying, hey, Crissy you still want to use our services, is this still where you live, is this still how much money you make, and is this still your email address, and I say yes. That’s all we’re asking for sites is to just sort of confirm that information versus key it in over and over again. 

And again, there’s the ability to collect CDAs within that process as well and other dynamic workflows such as delegation from a maybe PI to his or her CRC.  

But ultimately over the past few years WCG supported over 2,500 studies in the feasibility process and we’ve collected over 315,000 completed questionnaires across 85 countries. So that response rate that we have is also drastically more efficient than our competitors getting to that yes no of interest in less than 14 business days. 

And that tool in conjunction with the standardized questions captures insights on over 140,000 sites, which just goes back to they’re continuously updating their details about how they’re functioning, how they’re working, and we’re anticipating that that will also be updated to incorporate how they’re actually adopting the single IRB rule. And we’re doing that as I said in the least burdensome way for sites. But as we talked about, understanding how that single IRB rule impacts your site selection and feasibility process is important if your objectives are still focused on more rapid startup times because as Matt talked about earlier, it’s fundamentally something that can be done today if you’re looking to do that, and then we’ll obviously be moving towards the official mandate of that, upcoming. 

But with that I want to take some time, just to pause and answer some of the questions that have come up. So Matt, a lot of these right now are fundamentally around IRB, so I’m gonna put you in the hot seat here, and a couple of them you may have addressed during the discussion, but I just wanna make sure people’s answers, are received. 

But the first question there is just fundamentally when is the mandate gonna go in effect, and what type of trials are gonna be required to follow it? 

Matt Staves 

Okay. Great question. So we don’t know exactly when it’s going to go in effect, but the best guess we have right now from the conversations going on is it’s probably around the middle of next year. So it’s coming up in the near future, maybe nine months or so from now. And which kind of trials? It will be any multisite trials for the US component of that research. 

Cristin MacDonald 

Excellent, Thank you. And I think I touched on this one a couple of times in terms of what’s gonna happen. But the question is about ultimately, why is the FDA mandating this? But then the secondary question is, will it eliminate local IRBs and kind of what your vantage point is on that? 

Matt Staves  

Yeah. So for the first one, it’s that harmonization with the common rule, and with streamlining research. For the second, no. It absolutely won’t eliminate local IRBs. Those absolutely will still exist. You think, a single site research, investor initiated research, student research, these are right in the wheelhouse of what local IRBs will be doing and do right now, and they’ll absolutely be doing that in the future. As well as many of these local IRBs, are playing larger roles beyond just the IRB review. So things like determining, does this need radiology review? All of those needs will still exist even when single IRB is a mandate. So no, this won’t eliminate local IRBs, but in any shape or form, it just means if you’re doing multisite trials that you’ll need to use one of the single IRBs. Investigator initiated research, single site study, student research, local IRBs will still be around for those. 

Cristin MacDonald  

That’s awesome. Here’s one I’m actually really interested in understanding as well. So how would the single IRB review work if the study has US and OUS study or sites involved? 

Matt Staves  

It’s specific to the US component of that. So it’s just your US sites that are covered under the single IRB requirement. 

Cristin MacDonald  

Excellent. This one feels like a softball, but I’m gonna ask it anyway. So will centralized IRBs like WCG actually fulfill the mandate? 

Matt Staves  

Oh, of course. Yeah. That is what we do. Like, that’s what we’re thank you for the softball, by the way. Whoever submitted that, that’s my new friend. Yes. That’s what we’re built to do. That is our business. And you you think of the scale that comes with being a central IRB. We have hundreds and hundreds of people to work on your submissions, hundreds and hundreds of board members, twenty plus board meetings a week. So, the fact that this now becomes a requirement, is something that we’re built to handle. The volume is a non-issue for us. We’ve built an IRB system that is ready and can accommodate that. And for doing that review centrally of getting those benefits of increased timeline, of getting that consistency in your review, that’s exactly what we’re about. That’s the whole benefit of using WCG. 

Cristin MacDonald  

Yeah. There’s another really interesting question here tied to, I think, the mandate. Just asking whether auditing of central IRBs is something that the industry is currently doing today and sort of the level in which that… 

Matt Staves  

Oh, oh my gosh. Yes. So I think I heard someone mentioned where we’re probably the most audited entity in the United States, and it and it feels like that, fairly often, to which I always respond, I love that. That just the sheer enormous volume of auditing of us here at WCG’s IRB, it’s essential to that public trust in in what we do and into that quality of the reviews that that we deliver. So, yes, we are an audited entity that any given month, something is auditing us at any given time. 

Cristin MacDonald  

Excellent. Another question just in terms of is the FDA mandate, expected to be retroactive? So will it apply to studies already under, some other jurisdiction? 

Matt Staves  

Yeah. Great question there. It’s a go forward, regulation. So ones that are existing studies already had their IR IRB review already in process, those ones get grandfathered in. So no need to go back and redo, the existing, approvals. It’s simply on a go forward basis for new research.  

Cristin MacDonald 

Right, I think you covered sort of the function of the local IRBs piece., but this is a very thought provoking question that I’m gonna give you the open mic for here. But with that mandate, I guess the question here is kind of what trends do you actually foresee and how do you anticipate that central IRBs will sort of change, if at all, how they’re working today? 

Matt Staves  

Yeah. So that’s a great question. So I don’t think it will change a ton of how the central IRBs operate as they’re built to do this. And this is very frequently what we’re doing now today that we’re being used as the single IRB. And even cases where eighty percent of the sites have gone with the sponsor CRO sites, twenty percent have gone their own route. WCG, Central IRBs, we’re touching all your research right now. And so this won’t change fundamentally what we need to do. We’ve built a system that is already ready for this, and that operates in this fashion right now today. So, the trends I see it as a good thing for research that anytime you can harmonize rules, that reduces the burden upon people performing research. So, the fact that the common rule gets harmonized with the FDA requirements by and large, that’s a good thing. That makes life easier. 

Now you’re not sometimes doing a, sometimes doing b, as well as you get those benefits of a faster review, as well as more consistency in review. So I fundamentally view it as a good thing for research. I think they’ll be adapting for sponsors and CROs and sites of getting used to the fact that it is now a requirement, getting that comfort in saying, here is the central IRB we’ve selected. We all need to proceed with that. No longer an option. And sites and institutions getting comfortable with using, central IRBs if they don’t do so already. 

Cristin MacDonald  

Excellent. I’m gonna shift gears if you don’t mind and answer a couple of the type selection type of questions and feasibility questions that came in here.  

But there was one question asking specifically about the new FDA guidelines that are coming out related to diversity, equity, and inclusion, and whether or not we at WCG, identify sites that meet those requirements, and we do. 

So we kind of can utilize all of that data that we have from our niche service offerings that we had in conjunction with some real-world data and even EMR data to really highlight what investigators are likely to have the patient populations that you’re looking for, as well as what investigators, have had success in enrolling those particular patient populations or diverse patients into their clinical trials. 

So that is, again, some of that triangulated data that we have across a bunch of different service lines within our organization and through some of our licensed products as well. So, we do that, in terms of site selection or ultimately, we can even do some statistical modeling and analysis where we can actually create heat maps of a particular sponsor site locations based on some of that real world data so that they can actually see on a map whether they are, locating their sites in particular areas where, the patient populations that they’re looking to serve are. So, we can definitely support with all of that again bringing in some of that data and analytics that we have.  

And then there were a couple of questions just about total feasibility, and whether that’s available now. So that is available today. We offer that service today. The self-serve component is being released in January for members or companies and sponsors and CROs who want to utilize that on their own. So today, right now, it is just in the white glove service where we can do all of that outreach for you, and then we are again, as I said, moving in January to allow that, software to be purchased by organizations who are looking to run that feasibility process themselves.  

And what that does is just allow the entirety of the organization really to see the diversification of the sites that they’re utilizing to complete their portfolios, and ultimately do a little bit of prequalification, if you will, and feasibility to kind of click on certain investigators and understand not only where are they working, what therapeutic area they work in, but what types of trials they’ve run-in the past, and again, the capabilities of the facilities in which they’re conducting that trial. Trial. It also takes into account the fact that, as we know there are some investigators that operate at multiple different institutions and so, you can reach out to that investigator and find out, you know, which institution in particular they’re going to, be interested in running your trial at. 

So just a couple of questions there. 

There are many other amazing questions in this list that I don’t think that we’re going to be able to get through today, but I think we can certainly follow-up for anyone who has questions afterwards. 

With that, I first of all I want to thank you for coming and listening to Matt and I, it’s something that both of us I think are pretty passionate about in both of our areas. But you’re obviously here for a reason, this is something that’s interesting to you. 

So wanted to give all of you a heads up that the MAGI at Home event is happening next week, it’s virtually. The in-person event is in Boston in May, but for the MAGI at Home event there is a discount code there and I just want to draw your attention if you scan that QR code you’ll be able to see the full agenda. But ultimately there are two events there that I think would likely be interesting to you if you joined us here today. The first is on the 24^th of October. It’s a site feasibility and the importance of stakeholder engagement, which I think is really important in terms of what we’re seeing with ICH E6R3 and wanting to have cross functional feedback on protocols and documentation of that, being expected from sort of the FDA and other regulatory bodies. 

And then the second piece is really site metrics and understanding what you’re measuring, and I think a lot of that is gonna come into play. A lot of the things that we talked about today were understanding cycle times or how to decrease some of those cycle times. So those metrics are talking about things like IRB cycle times as well as, you know, contracts and budgets. So that’s also on the 24^th in an event that I think some of you may all be interested in. 

But with that, I want to thank you again for joining. Matt, I’m sure you also appreciate them coming. And again, if you have any questions, feel free to contact either our marketing colleagues here who were so kind to put this event together or Matt or myself and we will try to make sure we get those answers for you all.