Breaking the Bottleneck: Rethinking Study Start-Up for Faster Trial Activation

Study start-up remains one of the most persistent bottlenecks in clinical trials—slowing site activation, delaying patient enrollment, and adding pressure across already stretched teams. In this episode of WCG Talks Trials, host Jamie Harper, Vice President of Site Solutions & Engagement at WCG, is joined by Stephanie Held, Associate Director of Coverage Analysis, and Jody Ingebritsen‑Howe, Director of Contracts & Budgets, to unpack why start-up timelines continue to stall and what can be done to improve them. 

Key themes of this episode include: 

1. Study start-up remains a major source of trial delays. 
   Study activation continues to be one of the most significant bottlenecks in clinical research, impacting site readiness, patient enrollment, and overall trial timelines. 

2. Medicare Coverage Analysis (MCA) is foundational to efficient start-up. 
   A well-executed MCA serves as the backbone of compliant study activation. Early decisions made during the MCA process influence critical downstream activities such as budgeting, contract negotiations, and CTMS configuration. 

3. Hidden process gaps can significantly extend timelines. 
   Unidentified “white space” between handoffs, teams, and workflows often creates unnecessary delays. Mapping end-to-end processes and improving cross-functional alignment can help reduce friction and accelerate activation. 

4. Technology and AI can help, but expertise and collaboration remain essential. 
   While AI and automation have the potential to streamline study start-up activities, successful activation still depends on human judgment, strong communication, and alignment among sites, sponsors, and CROs. 

The bottom line – accelerating study start-up requires getting foundational processes right early, eliminating workflow inefficiencies, empowering teams with better information, and strategically leveraging technology without losing the value of human expertise. 

Transcript 

Jamie Harper: 
I’m Jamie Harper, and your host for today’s podcast. I currently serve as the VP of Site Solutions and Engagement for WCG, overseeing our CTMS portfolio, which encompasses both our CTMS product and CTMS services, as well as our direct-to-site service line. Prior to joining WCG, I served as the director of clinical research for a private oncology practice for 13 years, so the sites and their patients are always front of mind. And today, we’re exploring a topic that’s at the center of connecting potential clinical research participants and research sites, improving site startup timelines, and accelerating study activation. We mentioned in the 2026 Trends and Insights report that clinical trial complexity continues to climb. The pressure on sites and sponsors to launch studies faster and smarter have never been greater. Today, we’re diving into the foundational elements, the process gaps, emerging innovations reshaping the future of study startup. I’m joined by my colleagues Stephanie Held and Jody Ingebritsen Howe, experts in the study startup field. Stephanie, would you mind introducing yourself to our audience? 
 
Stephanie Held: 
Absolutely. My name is Stephanie Heltz, and I’m the associate director for coverage analysis here at WCG. I’ve been with the team going on nine years now, focused on billing compliance that entire time, and my team handles all of the coverage analyzes with the study startup team, and we work across hundreds of sites and with every indication and therapeutic area out there. 
 
Jamie Harper: 
Thank you, Stephanie. That’s a broad level of experience that you have. Thank you for joining us today, Jody. Would you mind sharing a little bit about yourself? 
 
Jody Ingebritsen-Howe: 
Of course, I am Jody Ingabritsen Howe. I’m the director of contracts and budgets here at WCG. I’ve been here just over 10 years. Initially focused on the contract side, and then taking over the budget teams in the last couple years, and now my focus is really in the negotiation space. Same as Steph, we’ve been working with sites of all sizes, all processes, and all sorts of disease indications for the entirety of my time here, so really happy to be chatting today. 
 
Jamie Harper: 
Thank you so much, Jody. Appreciate you being here today, and I’d like to actually direct my first question to you. So, with accelerating study activation timelines, that’s been a constant thread that’s been pulled through the last several years, why do you think steady startup remains such a persistent bottleneck in clinical trials, and what makes improving these timelines so critical this year and beyond? 
 
Jody Ingebritsen-Howe: 
Yeah, the most obvious answer to this question is negotiations, right? So the very nature of negotiations in the startup space is that we have at least two entities at the table, sometimes more. We’re discussing a potentially very complicated protocol, very complicated operational hurdles for any site to perform a study. The site’s going to come at the situation with a list of things they need in order to perform the study, not lose money in doing so, and then just ensure their various internal departments, positions, and other staff members are willing to continue assisting with research. There’s limitations in terms of federal regulations, state law, local laws, and then internal policies, and then that’s all just one side of the equation, right? Then you have a sponsor or the entities working on their behalf with the notion of how much they want to pay each site to participate. They also have those limitations then in terms of cost, in terms of how they can actually pay each site, and then things like federal regulations on their side. Adding to this, for the actual question about bottlenecks, are that each entity has about 75 competing priorities at any given time, and you can just hear in those couple sentences all the situations that are ripe for bottlenecks and slowdowns. And there’s some sneaky reasons for bottlenecks too. So things that we call white spaces here at WCG, which these are lag times during and between services, things like handoffs, reviews, secondary reviews, approvals, congruency checks, that sort of thing, and all of this can be sneaky because they’re not always tracked or it’s easy to spot, and they take a more purposeful effort to resolve. So, mapping all of this out and looking at timelines, speeding up, clearing out your inefficiencies-it’s more important now than ever because speed to activation is how we’re actually how quickly we can get patients enrolled in sites is most important to everyone. We want to get the science to improve. We want to get patients to be able to participate in study and make things better for the entire industry, and so anything we can do to chip away at inefficiencies helps the industry as a whole. 
 
Jamie Harper: 
Yeah, those are great points, Jody, and I think our listeners would agree that 75 competing priorities at any given time is generous. 
 
Jody Ingebritsen-Howe: 
Exactly. I think a lot of staff they’re wearing so many hats. They’re they’re doing this review. They’re also hearing about another study coming down the pipeline, and then someone is asking them to finalize one that’s been sitting with them for a couple days. And that’s best case scenario, 75. I feel maybe that’s an exaggeration, but also maybe not. Unfortunately, yeah, 
 
Jamie Harper: 
absolutely. And it seems that the process that starts to kick it all off is that Medicare coverage analysis, and I know we emphasized that during the Trends and Insights report as the MCA being the foundation of compliant and efficient startup. Stephanie, could you share how a well-executed MCA can streamline downstream components like the budgeting and the budget negotiations, contract negotiations, and even CTMS utilization. 
 
Stephanie Held: 
Indeed, I can. MCA creation should be your first step in your order of operations for internal budget development, then flowing into negotiations and ultimately full integration into your CTMS. While some components could definitely be done in tandem, like contract negotiations and potentially CTMS calendar billed pieces, the Medicare coverage analysis will inform what can be billed to the patient insurance versus what needs to be billed to the sponsor. It’s crucial that your final documents are in alignment, so identifying these things up front enables accurate budget creation and ensures that designations are incorporated appropriately then into your finalized budget and ultimately a CTMS billed for accurate patient billing. 
 
Jamie Harper: 
Yeah, absolutely, and it’s important that you noted that those processes can and should happen in tandem. It’s easy to look at that process flow as silos that are related to each individual task that needs to be completed. And one of the exercises that we walk through at WCG is understanding that big picture process flow. This really helps us zoom out to see any glaring opportunities for efficiencies when we do this exercise. So, Jody, I would love to hear your thoughts about looking at the big picture process and how that really correlates to end-to-end study activation timelines. 
 
Jody Ingebritsen-Howe: 
Yeah, I think something that’s really important for every site is just the understanding that the process looks different for everyone. There are pieces that do have to be a little bit more siloed off, right? The CA has to be done first before you get into budgets, and that’s just because otherwise your budget isn’t fully baked and you’re not fully informed going into everything, right? So there are certain things that make sense to be siloed, but but the important thing is that when you’re looking at your own process, you do zoom out and you look at it specific to your site. And one of the things that we typically do and that we recommend for new sites that we’re working with, is to literally map it out for your entity with as much specificity as you possibly can. Put together some sort of a process flow, and stick in names, stick in departments, stick in various stakeholders that need to be involved in each step of the process, and establish basically establish what you want the flow to look like for your site, and what you said, Jamie, is talking at looking at glaring opportunities for efficiencies. One thing that, as part of this recommendation to map it out, is actually look at the white spaces too. So between services, establishing goal timelines not only for the service itself, so you want you know your CA to be completed in a week, but then also establish a timeline for you want the CA to then be reviewed within how many days? Within a week? Within two days? Whatever it is, because that’s the thing that I was mentioning before. That’s a lag time or a white space that can go untracked and unmonitored. It can actually be a massive driver for long timelines that kind of slips under the radar, right? So zoom out, map up what the process looks like for your site, and then get to a really granular level of what you want to see, and the thing is, you’re not going to be able to resolve all of your inefficiencies within two days. But mapping this out potentially for each department or for each study type or for specific PIs potentially, you can identify common sticking points when you have it mapped out, you can problem solve in a really strategic way around those. There might be a specific solution for the neurology team, right? Those studies are taking three times longer to negotiate than others. Why is that? Oh, it’s because the people that are reviewing the neurology budgets are stretched so thin; it’s taking them longer. Whatever the case may be, but looking at each specific process at that granular level will actually help you be a bit more focused in your problem solving. And then figuring out: Do we need better documentation for certain types of studies, or do we need better resources? Do we need to give our negotiators more information for these types of departments? That kind of thing can go a really long way to get rid of either known efficiency issues or the unknowns that are slipping through the cracks. I think that’s one of the best things we can do as a starting point. It can absolutely correlate to end-to-end study timelines because if you’ve got a big gap between the CA and the budget, where there’s an approval that goes for two weeks, and then the budget team is unaware that there’s already been this much time eaten up at the start of the process, and they’re not considering that in their negotiation timeline, you’ve just got all of these other factors that are downstream that are causing these elongated timelines that we can really solve that if we map it all out. That’s I guess that’s the ticket. It’s not necessarily that zooming out and painting what the big picture should look like is going to fix it in every instance, but it might help you and your team have pretty effective problem solving around those common sticking points and white spaces. 
 
Jamie Harper: 
Yeah, I loved that you mentioned setting expectations. It’s really easy to say do it faster, do it quicker. We need it now, but what does that truly mean? If the expectation is five days, doing it faster means you’re at 13. We need it at five. So really, setting those expectations up front will help those conversations when those timelines do start to lag and drag. 
 
Jody Ingebritsen-Howe: 
I think a point on that is what we what Steph was talking about earlier is that if you have a really complicated protocol and the coverage analysis is set up. It takes a little bit of extra time because of the complexity level, and there’s conversations that need to happen between the people doing the coverage analysis and the people that will ultimately be negotiating the budget. Taking a beat there and having some questions and assumptions all sorted out, making sure there’s alignment, making sure there’s not additional questions. That can go a really long way. So you might eat up an extra couple days at the front end of this timeline, just sorting out protocol nuances that are identified in the MCA that then will affect the budget. It might take a couple extra days, but if it then helps the negotiators and clears up confusion and avoids unnecessary back and forth with the sponsor during negotiations, it’s absolutely worthwhile. You know what I mean? It’s not something that is oh, it’s bad because it took an extra two days. No, if it’s a valid extra white space, you should absolutely support it. And then it’s just making sure that the teams are all in alignment. Always, it’s definitely the end goal. 
 
Stephanie Held: 
Yeah, you took the words right out of my mouth, Jody. I was going to say while there are areas of expertise, of course, you’re going to have your folks that are dedicated to coverage analysis, budget negotiations. It’s important to have the awareness of the downstream effects of things and how the teams can work together. Very good point. Valid white space to get those things sorted out up front. 
 
Jamie Harper: 
Absolutely. And then pulling in that CTMS perspective, one of the biggest efficiencies we’ve seen is taking into consideration how each of those functional groups-so the finance team, the regulatory team, compliance team, the clinical research coordinators-how they’re all going to use that CTMS platform, and then breaking down those silos to make one comprehensive platform for conducting a study. And this is just one very simplified area where technology can make an impact on reducing those study startup frictions. Stephanie, as coverage analysis is often the beginning of these workflows, what considerations do you have towards utilizing technology to make an impact? 
 
Stephanie Held: 
Yeah. So with CI being step one, we absolutely need to be able to strike the balance of completing the coverage analysis through the billing compliance lens, making sure that it is easy to read, interpret, and work with, but also anticipate those downstream effects as it integrates with the pieces of technology that are integral to site operations and keeping things moving quickly and efficiently, there things like the structure of the MCA that rolls then directly into budget format that will be needed for negotiations, and then will roll and be built into the CTMS. Even small details, think character limits in CTMS systems, how a sponsor budget structures a visit, or nuances of how items are labeled. Everything comes into play when you’re looking at eliminating all of those friction points and even the tiniest bit of white space. 
 
Jamie Harper: 
Yeah, character limits people don’t often consider when doing a coverage analysis or a budget, or but it’s something very real for a CTMS analyst who’s is trying to build that protocol in an accurate and efficient way in the system, Stephanie. I’m going to stay with you and ask if you could recommend one actionable step that any site or sponsor could take today to meaningfully improve startup timelines. What would it be? 
 
Stephanie Held: 
Of course, I’m a little biased through the MCA lens, but please build your MCA before your budget is final. It can create lots of duplicate work. It will delay your timelines if designations need to be updated during negotiations, and even carries compliance risks of documents not aligning if you don’t have the MCA Foundation built prior to jumping into negotiations. Please just take a look at the compliance aspect of it first to make sure that you have the good foundation, so everything can run smoothly from there. 
 
Jamie Harper: 
Jody, what recommendations would you have? 
 
Jody Ingebritsen-Howe: 
I think I I alluded to it before, but mapping out your startup process is for any site out there is my biggest recommendation, and because Jeff, you gave your CA lens. I’ll give my negotiation lens here. Make sure your negotiators are equipped with actually helpful information. So if your contract negotiators don’t actually know what your legal team needs to see in each contract, they’re just guessing each time. That’s not going to be an efficient process. If your budget negotiators do not have information from each specific department or your centralized office on what they can and can’t accept, or wiggle room on specific items that they can negotiate, then again, they’re just grasping at straws, and they’re having to elevate everything for approval, and they don’t really know what they can and can’t accept going forward. So talk to the actual people doing the work, see what the common sticking points are, see what their issues are, and figure out solutions around that. Maybe they need better documentation around specific departments. Maybe they just need more guidance from various stakeholders. But that’s going to be one of my biggest recommendations. And then you can actually create better negotiators just by having them as informed and as in alignment with each department as possible. And my last recommendation is: don’t be afraid of a little trial and error. Test something out in terms of seeing if it can create an efficiency. When you’ve mapped it all out, hey, maybe we could have only one review for this CA before it goes into the budget team, instead of the three that normally has to happen, or maybe bypass that entirely. Figure out different departments what they need, but don’t be afraid of a little trial and error, and then circle back and figure out what worked and what didn’t work. And that’s a great way to to tackle this issue for sure. 
 
Jamie Harper: 
Yeah, I would agree. I think my recommendation would be, from the CTMS perspective, is understanding how each end user is going to utilize the system and what they need out of that system. So, being able to upfront operationalize a protocol within the platform will save a lot of time on the back end when and prevent errors or revisions or multiple versions of the same protocol being in the system because things need fixed or they weren’t addressed for a particular department when it was originally built. So fully understanding how all of the different departments functionalize and operationalize a protocol will be key to finalizing that protocol on the back end and sticking with technology. We’ve seen rapid developments in technology, and it’s not hard to see that the tech industry will play a key role in advancing healthcare. So as we look one to two years ahead, Jody, what do you see reshaping study activation? 
 
Jody Ingebritsen-Howe: 
Yeah, I think we’re probably all anticipating the answer of AI here, right? We’re all figuring out ways that AI can assist in in my world in the negotiation space. Can it provide better predictive analytics and help us utilize our own data in a more streamlined and speed-oriented manner. Having AI or other systems, tech systems, build smarter workflows and workflow systems. Basically, we just want to ensure that none of us in this industry, are doing things just to maintain the status quo. If there’s something that can be improved for the sake of efficiency, we are looking at ways to improve it. And I think just all of us are looking at tech right now and figuring out how it can help us and serve us in that sort of discussion and get us 2j startup timelines. That’s what we want. So we just have to figure out how to get closer. And Steph, if you have any other ideas on this, I’m all yours. But I think that’s where my brain’s at. 
 
Stephanie Held: 
Yeah, absolutely. We’re in alignment on most of that, of course. Obviously, AI is a promising area, in specifically through the CA lens, distilling some of those complex regulations and helping ensure compliance there with a human in the loop. Of course, the risk is absolutely too high. Please do not blindly trust AI on Medicare compliance pieces. But even things such as human alignment, overall study sort of processes, making sure everything is congruent at the end of it. There’s certainly a lot of promise there, and we’re seeing some rapid evolvement with AI, so it’ll be interesting to see what comes about in the next few years here. 
 
Jamie Harper: 
Yeah, I agree that human in the loop is going to be vitally important as we continue to move down the road of AI in healthcare. We’ve covered a lot of ground today, and hopefully, we’ve brought to light some of the challenges experienced during the study activation process, and some thoughts on how to mitigate those challenges for efficient and effective study startup. Before we wrap up, I want to thank our guests for joining me today and sharing your insights on this episode of WCG Talks Trials, and thank you to our listeners for tuning in. If you have any questions or would like to read more insights from the WCG 2026 Trends and Insights Reports, you can visit wcglinical.com/insights. And don’t forget to subscribe to our podcast and follow us on your favorite listening platforms like Apple Podcasts, YouTube, and Spotify, so you never miss an episode of WCG Talks Trials. We hope you found this episode insightful, and that you’ll join us for future episodes of WCG Talks Trials. Until next time.