Watch our webinar for research sites and institutions as we dive into actionable strategies for expediting study activation and study start-up timelines. Gain insights into how operational silos during study activation can adversely impact start-up timelines and compliance, slow research progress, and potentially jeopardize study outcomes. Explore a more streamlined and integrated approach that improves trial efficiency and participant care with experts from Yale Cancer Center and WCG.

View this webinar to gain valuable insights into:  

• Proven strategies for accelerating study activation timelines. 

• How to fix silos in your study activation before they impact your timelines and compliance. 

• Understanding the effects of study activation processes on participants. 

Transcript 

Jessica Thurmond: 

Hello everyone. My name is Jessica Thurmond, and I am a program director here at WCG. I would like to welcome you to today’s webinar: Accelerating Study Activation, Breaking Down Silos for Startup Success. I’m excited to be joined today by four industry experts, all of which I’ve had the pleasure of working closely with. So a big welcome to our speakers. First, I’d like to introduce you to Adam Roshka of Yale Cancer Center. Adam. 

Adam Roshka: 

Hi, thank you, Adam Roshka. I am the finance director for the Yale Cancer Center with a focus on the Clinical Trials Office. 

Jessica Thurmond: 

Thanks for being here, Adam. Next, we have Juliann Murphy, also with Yale Cancer Center. 

Juliann Murphy: 

Thanks, Jess. Hi, I’m Julie Murphy. I am the assistant director of clinical trials office at the Ear Cancer Center. 

Jessica Thurmond: 

Awesome. Thanks, Judy. Jody Ingebritsen-Howe, who’s here with us at WCG. 

Jody Ingebritsen-Howe: 

Thanks, Jess. So yeah, I’m Jody. I’m the director of contracts and budgets here at WCG. 

Jessica Thurmond: 

Awesome, and last but certainly not least, we have Sarah Garner, also of WCG.  

Sarah Garner: 

Hi, thanks, Jess. I’m Sarah Garner. I am a senior manager of CTMS services here with WCG.  

Jessica Thurmond: 

Thanks so much, everyone. Before we get started, we’ll just quickly go over today’s agenda and a few other housekeeping items. We’ll have introductions, overview, and industry data. So I’ll just talk about a few data points before we really get into the sections everyone cares about. So startup timelines and white space, study startup perspectives from Yale, CTMS silos, and then a panel discussion and audience questions where we invite everyone to engage and submit questions through our Q and A, and then we will conclude for the day. So, as most people might know, WCG conducts a site survey every year, looking at industry trends, challenges, obstacles to being able to start up and implement studies. This is our recent report from 2024. In terms of the changes that happened from 2023 to 2024, there weren’t a significant number of shifts within the top five that you’ll see. Complexity of clinical trials continues to be one of the largest burdens that we hear about, followed by recruitment and retention, study startup, which includes most of everything that we’re going to be talking about today, and site staffing is actually one that decreased. We think that’s a little bit of you know remnants of the pandemic kind of wearing off and sites kind of adjusting to that a bit more, along with long study timeline activation. So for me, when I think about this and I think about the clients that we’re working with and I you know the sites I see on a daily basis, study activation is so often impacted by the complexity of our trials, and that comes down to the phase of the study, the therapeutic indication, and that all has downstream impacts on how we’re able to negotiate a budget coverage analysis, your CTMS builds, which then has further downstream impact on your financial ability to be able to recognize revenue once those charges drop down, and so the more complex studies are, the harder it is for us to be able to do that and then do all of that in a timely fashion. And so with that, we know that the vast majority of sites fail to meet their enrollment targets as well as their time to activation, and this kind of varies, you know. So we have a large contingency of academic medical centers on here. So I think it comes as no surprise to most of you that time to activation is incredibly important. In fact, we know that for most AMCs, there’s been a trend of 9.4 months to be able to open versus the 4.8 months for independent sites. There’s added layers of bureaucracy. I think our friends who are here at Yale today can talk about the challenges of really kind of steering a large ship and being able to be nimble. And I think that’s one of the most critical components that you’ll hear the teams talk about today is our ability to be able to pivot quickly to be able to look at data in real time and make informed decisions about how we’re conducting and running our clinical trials operationally, based on the data that we’re being fed consistently. With that, we have kind of just what we look at from the overall trial timeline. So these are kind of this can look different based on every site. There might be different orders that you have based on your own internal processes. So we really break down each section of the study startup process, and then we look at things in terms of how many handoffs there are that are taking place. What is the window of time that a handoff can take when you’re getting a signature on a contract or a budget? What is a QA process? Because it sounds easy when we lay it out that sure we want to be able to activate trials within 90 days, but when you really start to parse out the 48-hour periods of time and you start to hack out the business days and move to calendar days, you find that you’re really just squeezing for like a day or two here and there to be able to really whittle that timeline down. And with that, you know, I think I’ll pass this over to more of my colleagues who have a little bit more understanding and experience here. And Jody, happy to pass it along to you. 

Jody Ingebritsen-Howe: 

Perfect. Thanks, Jess. Yeah. So the startup process is going to include everything when we’re talking today between site selection through execution of your contract, and then also the CTMS financial entry and EHR builds. What we’re going to do is suggest looking at each the performance of each individual service as part of this process. So each green box here, and understand that these services do take some time. So we’re all in the same industry. We know everybody wants everything done within the course of a single business day, but we do want the protocol thoroughly reviewed while the CA and budget are being developed. You do want your contract to be read thoroughly, upfront effort, and spending a little bit of time to do quality work on that. You know, in the start of our process here, is going to save time. You know, make everybody more efficient and avoid these 11th-hour requests in the negotiations, and then delay CTA execution. So, on my strategy slides, we’re going to talk about streamlining the performance of services and making sure everyone’s as efficient as possible. I’m not going to sit here and tell you that this entire process can be done in a single workday. That’s not that’s not what I’m doing today. But I do hope you leave the webinar with some ideas for how you can streamline the process for each service individually. My green box is here, and at your entity, and then also some of the other timelines that are affecting our target goal here. Which Craig, I’ll have you go to the next slide. The sneaky timelines that exist within the startup diagram here are the white spaces. So that’s what that’s what we’re calling these: the handoffs, the reviews, approvals that happen between the performance of each of these individual services. Some perfectly necessary, perfectly valid. They help make sure that you’ve got a quality, you know, review happening. Again, they help to avoid 11th-hour, you know, negotiation fiascos or delayed CTE executions. Some might be less valid. A valid white space example might be that very first one getting documents to start performance of services from the sponsor, so you have been selected to perform the study. Here’s the protocol. Okay, where’s the contract? Where’s the sponsor budget template? We need to get all of those things. So that is a valid white space because it’s not you know it’s not a delay that we can avoid. You do need those documents to start everything, another valid white space would be necessary reviews and approvals. That’s my conditional word. There is necessary approval of the CTA, or sorry, the coverage analysis and the budget upfront. Perhaps you send it to the study team or the PI. Make sure that everything built, you know, pursuant to this protocol looks accurate with how they would normally perform this study. Hey, every time that I perform X, I also perform Y. So that should be built into the budget as well. That should be you know considered here. That’s going to avoid again 11th hour delays on the negotiation side. So having a review of your CA and your budget upfront. I would consider that to be a good idea, necessary, you know, with some conditions. But I think that that’s a good a good idea. This third white space here, I’m going to focus on after the budget negotiation and after the contract negotiation, prior to getting those documents signed. I think it’s a good idea to have a brief pause to have the team review the final PDF that’s getting signed. Make sure that everything in that matches what was just agreed upon in negotiations. There could be errors. Maybe the wrong document was sent. Just make sure someone’s pausing to review before signing. That I would consider a valid white space. Invalid white space examples would be upfront here, just delays in getting the documents to the right people. So you’ve been selected for a study. Here’s all the documents you need, and then the documents sit in someone’s inbox for two weeks. That would be an invalid white space, in my opinion. We got to look at ways to streamline that, add more people as recipients to that email, and establish a green light system where all you have to do is they go and they can they can move instead of having everything go to one person and then sit with that person for too long. Unnecessary reviews, unnecessary approvals, unchecked bottlenecks, essentially. So we have the coverage analysis and the budget, and they need to be reviewed prior to going into negotiations. They need to be reviewed by seven people because we’ve always had seven people review it. Take a good hard look at that. Those reviews and those approvals. How many of them are necessary? Because each time that a document or a service has to be handed off from one person to someone else, that handoff creates the potential for a delay. Someone doesn’t see an email in their inbox. Someone is on vacation. Every handoff creates this potential for an unnecessary white space delay, which you want to tackle. Reviews and approvals that exist in this white space, you know, that are completely necessary, but there’s no timeline expectation. So when you get something, you got to review it within one day, within two days. That’s an expectation we’re going to impose upon this process, making sure that people understand their expectations. So it’s not just willy nilly. We didn’t realize there was an expectation here. Make sure that’s understood. Inefficient finalization processes. That’s about that CTA execution. Just making sure it’s not dragging out for longer than necessary, and then delays in the handoff between CTA execution and the actual start of your financial builds. Just because you know maybe the CTMS team isn’t aware that the CTA got signed, it should have been aware it sat again in someone’s inbox, and that notification didn’t happen. So taking a good hard look at how necessary each of those white spaces are and how we can eliminate them. All right, my next slide here. All right, so here’s some strategies for streamlining the whole thing, not just the white spaces. First thing, what I would recommend doing is mapping out the entire startup process for your entity. What it looks like, name people, name departments, whoever needs to be involved, not only in the green boxes but in the white spaces. Who was involved in the handoffs? Who’s involved in the service performance? Map it all out. Map out different situations, different departments, phase one studies, lower priority studies, map it all out. So you’ve got a whole. It might take a little time, but you’ve got a detailed look at what the process actually looks like for your entity. Then look at what your target goal is, your timeline. So let’s say it’s 90 days, zero to 90. Figuring out, okay, if we have 90 days, and then here’s the process for our entity with each individual. Now I’m going to go talk to each individual or each department and figure out what is involved in their performance, and what could we do to make their the performance of their services a bit easier, a bit faster, making sure that they understand that there are timeline expectations and talk to them about what their common roadblocks are. This is one thing I’ll kind of get on a soapbox about a lot. Is that you know I talk to leaders all the time and leaders absolutely we can see this diagram of what it looks like. But until you talk to the people doing the day to day work, sometimes it’s not clear. Sometimes it’s not known. There might be solutions built in for somebody that has been at your entity for 10 days, but they might see a solution that no one else is seeing. So talk to the people that are doing the actual work to find out where you might have some unnecessary roadblock or known roadblocks or things that you can kind of chip away at, and then look at the white spaces themselves. Which ones can be eliminated? Who’s who is involved in each of the white spaces? And figure out if you know if the reason that you’re doing something is we’ve always done it this way. Take a good hard look at that. That might not be a valid reason to perform that you know that white space anymore. Why it exists anymore? Maybe there’s a better way to do things if you just think about the problem and the entire process a little bit differently. All right, my next slide, and then just continuing in your map for your institution, we’re gonna look for any unchecked bottlenecks. So that is something that you know, a lot of times, especially in the past when there were staffing, more staffing issues. If we heard about one person doing essentially the entire process, or at least the CA budget and contract, and then maybe separate for the regulatory teams. But if there’s too few people doing everything, that might be totally fine if you’re running one study at a time, but as soon as you get the third study, the fourth study, the 20th study, not only the CA timeline, but now they’ve got negotiation timelines to respect, and they’ve got handoffs, and they’ve got all this other stuff going on. You can see how one person can get spread pretty thin, and the first thing that’s going to fall are those timeline expectations. So double check those bottlenecks and see if there are actual, you know, staffing and resourcing solutions to some of these problems, too, tapping in other people from other departments to help out, increasing staffing just to make sure that the more studies you try to run, you don’t impact all of your timelines in this way. Staff should be trained to zoom out and always be thinking about the target goal. So, if a single service takes longer than you want it to, you want everyone on the end, you know, the negotiators to be aware of that. So, if you know, let’s just say the initial handoff before you know regulatory and CA and contract services could start. That handoff took 20 days. Your negotiators should know that. So, if you’re still pretty serious about that 90-day target goal, which I would argue that’s that’s important, right? So for the next study, we’re going to work at chipping away at that initial handoff. But for this study, your negotiators should know that so that they don’t think they still have as much time as they normally do to get everything done. They should know exactly, you know. All right, I’ve only got 50 days left here. I really got to come into this negotiation with concessions ready to go, and I have to notify people the entire time that I’m going to be pushed, just so that we can take a good, you know, take a look at everything and see what’s still realistic. If your negotiators have to make up the time for a slowdown at the start, that might be perfectly fine, or maybe I might have to push that target goal for a single study. Double check if your services themselves are standardized, and what I mean by that is, the people doing each of the services do they know exactly how to be as efficient and as effective as possible, or for each project do they have to get input from seven different people along the way, and the input just varies based on well, I had a bad experience with that last project, so let’s ask for three times the money on this one. Okay, does your negotiator are they equipped with that information in some sort of a standardized form so that they’re able to do their job well the first time to hopefully eliminate the need to get input from a bunch of different people. Which every time you’re getting input, that’s a handoff, that’s a white space. So there’s a situation where we might have too many cooks in the kitchen, where too many people are providing input. Is the input based on a feeling that day? Is that based on you know some sort of a budget meeting that was had that people are feeling tight or are the negotiators being equipped with basically do your best and we’ll tell you if it’s not good enough that’s not quite what we want so you want to standardize as much as possible to make sure that the people doing the actual negotiations on the back end know exactly what they have to go in and ask for and get. Same for contracts. I would say this happens for contracts a little bit more than budgets. Is make sure that they know what they can, what they should be fighting for. They should know what their non-negotiables are. Same for budgets, but make sure they’re not fighting just for the sake of fighting. I would say there’s some you know situations where a contract negotiator maybe belongs at a litigation law firm. We’re not respecting time anymore. We just want to argue. We love arguing. That mindset might not be right for this industry. Maybe it is. Maybe that’s exactly what you want. But make sure that those negotiators always have the mindset of time and making reasonable concessions within that time, or always looking for solutions and not just arguing for the sake of arguing. Last but not least, reevaluate. Don’t be afraid to remap every time. You know, if you get staff changeover or if you have you know new departments that want to take part in research, reevaluate, remap, and if you’re only able to tackle a couple strategies at a time, try new strategies. See what works. See what doesn’t work. Talk to the people doing the work again and figure out what are their pain points are and their roadblocks are, and really just try to come at this and brainstorm as much as much as possible. And now I’ll hand it off to my friends at Yale to so they can talk about some of their solutions that they’ve implemented. 

Adam Roshka: 

Thank you, Jody. So, as mentioned, Julie and I are here to talk about our perspective in the process, and we’re going to take you through a few slides to go through that process, and then we’ll hand it off one more time. We’ll open it up for questions. So, as Jody mentioned, there’s a large number of processes and steps throughout the activation process, and Yale about three years ago, Yale found that our processes and our timelines were really impacting our ability to be successful with our studies. Our timelines were outside of our expectations, and they were also outside the expectations of the benchmarks of our peer institutions. So what did we do? We embarked on a, I’ll call it a deep evaluation of all the processes because we determined that change was needed and we needed to make sure that we had institutional buy-in. So we needed to document all those processes, all those processes. So what did we do? We embarked on this very comprehensive project to evaluate our processes. We worked to identify all the steps that required are required in the processes, including those that required input, those that required review, or those that required approval. We worked to determine the essential requirements for approval to move forward. So, what are the checkoffs and sign-offs that are needed, and who are the people either in the roles or individuals for those approvals? It’s really important to know that the deep evaluation does not need to be a one-time, and it should not be a one-time process. It’s important to review this on a consistent basis because efficiency opportunities or new roadblocks could come up at any time in the process, including when there’s impacts in policy changes or sponsor changes. We also wanted to make sure that we were reviewing duplicate processes and making sure that we were ensuring that reviews that required multiple parties to review. We’re flowing through that process quickly, kind of eliminating the white noise or the white space, as Jody mentioned. And for Yale, this did result in a significant decrease in the number of touch points and the approval time in the overall process. 

Juliann Murphy: 

So we thought that documentation and collaboration was very important. We noticed initially that we had a lot of varied perspectives. You know, was one of our biggest challenges. You know, the process owners, the end users, all had different understandings of the process with different perspectives, pain points, and barriers. You know, like for example, our finance team was focused on all of their budget constraints, while we had our research team prioritizing on their areas for activation. And we realized that without documentation or a unified process, we were very siloed. Our workflows were siloed. We had fragmented communication, timeline issues, and a lot of inefficiencies. So what we did, we went to a bundled approach. We documented our workflows, and that led to improved timelines and reduced delays and just created a more streamlined process. Tracking and targets. One of our key questions is: Is are we tracking our process efficiently? We are now implementing dashboards where we can to kind of really show our tracking at all points because without those, we realized that it was really hard for us to identify where we had our delays or our performance issues. And we are also, as Adam mentioned, regular. We are regularly reviewing these metrics within our unit as well as within leadership. So that just kind of allows us to make sure we’re all realigned, and our efficiencies are always being improved and looked upon. 

Adam Roshka: 

So another thing that’s very important is collaboration. So every organization is different. At Yale, we have multiple units that are assisting and working towards the common goal of activating our studies as quickly as possible, so obviously inclusion matters. So these processes are not limited, as I just said. They are spanning departments, spanning units, and too often we found that decisions were being made in isolation without the understanding of how that decision was impacting either the next step or the steps that are being done concurrently, so we wanted to engage all process owners very early on and remain engaged with them. So this is the leadership meetings. These are the discussions where key principles in the process are meeting. This is an example where more work is required to gain efficiency. We also wanted to make sure that we are improving Communication. So, the workflow may not change, and we found this with some of the deep dives that we did. That the workflow didn’t change, but there was some communication that needed to be improved. And actually, reaching out and having those communication and that getting that feedback was explaining and getting buy-in to the process. And it actually did reduce errors and reduce handoffs in the process. So regular meetings, workflow documentation, and a feedback loop ensured that everyone was on the same page. So in our in our space, as an example, the pre-award team implemented a weekly standing meeting to review budgets in in progress with our vendor with WCG, by doing this, we ensured a proactive approach to picking up issues that maybe were going to be escalated or needed to be escalated in a timely manner, and we significantly improved our turnaround times and reduced delays. It’s really important if people understand their roles and how they contribute, it makes the environment more cohesive and the process and workflows more efficient. Okay, so as I mentioned in the earlier slide, this process is not a one-time event; it’s ongoing. We are always looking at our data. We are always looking at our task lists and making sure that we understand where the bottlenecks are in the process. As we said, white space, white noise is a real thing. What’s the wait time for review from sponsors? Do we need to escalate something to a sponsor because a CRO is involved and we’re having trouble getting feedback or getting an answer on a certain issue? What’s the internal stakeholders process for review and for approval? Do we need to understand who the escalation points are? The goal here is to optimize workflows and to make the process efficient over time. 

Juliann Murphy: 

Proactive problem solving, just identifying things earlier to kind of eliminate barriers. What one of our biggest shifts were was when our budget team did start those meetings that Adam said previously to really open our communications to go from being in a reactionary state into a proactive strategy, and one of our biggest wins here at Yale was is we have recently resulted, and currently we have zero budgets initially that are exceeding 90 days, and that was kind of a really big shift that we’ve been working on to get our section of that timeline really reduced. 

Adam Roshka: 

So, process versus resources. So, and this is a little bit. We viewed it as we needed to understand the process before we started looking at the resources. So, how can we make sure that the process processes are working so that we can then address what kind of resources and who we need to involve in those processes. They need to be structured for maximum efficiency where possible. Only after the process optimizations are in place did we start to look at the resource allocation, and that includes financial considerations within that resource allocation. So one thing that’s very important. Is that efficiency, in our experience, did not always translate into cost savings. I think there’s at times we think of efficiency means that we’re going to somehow save costs. That’s not always the case. Investment might be required to make sure that we are processing things in a more compliant, a bit more compliant from not only the regulatory space but institutional space, and making sure that we have higher outcomes in the overall process. 

Juliann Murphy: 

So, really identifying and addressing institutional barriers. There’s really two kinds: are they removable or are they really hard barriers? So, for like removable barriers, just to process any inefficiencies, can we reposition time points to reduce timelines? Can we maximize efficiencies, redundant reviews, approval steps? You know, putting them all in a cohesive area, establishing recurring meetings to improve communication and streamline. Those are really the removable barriers that we’ve found that we could do. Hard barriers. We know that there’s the congruency reviews, legal escalations, contract challenges that we have, and if we notice that if there are certain barriers that can’t be reviewed. Can they be repositioned or sequenced differently to help moving things along more efficiently? Optimizing the budget process-it’s really a two-step process here that we work very closely with WCG at Yale, so we have the budget development. Two big things that we do is leveraging your past data. You know, making sure that you’re looking at previous budget performance to help guide you for future decisions. Standardizing your fees, align them with negotiated budgets whenever possible. We always want to like know your fees and know your rules within the development and the negotiations. We have kind of found what our sweet spot of escalation is. We identified an earlier escalation point for negotiation. So we used to be escalating things that were over 90 days. We have now shortened that to really what is our sweet spot where, after going round of rounds of negotiations, you know where we you know have our maximum, you know let’s just cut the budget and move on. So we have that sweet spot, and we also have that escalation process now identify whether the sponsor has a designated liaison for your site when you are getting roadblocks, as this can streamline communication and decision making. Just because something we realize something is negotiable, it doesn’t or non-negotiable doesn’t mean it’s free because every cost, every fee has a real cost and a financial risk. So we found here at Yale that it’s crucial to ensure that your financial implications are fully understood while you’re making these decision making. 

Adam Roshka: 

So lessons learned. So try to sum this up in a in an easy way. So building strong relationships matters, and I will say, it’s not just the relationships again internal to your site. Building relationships with your sponsors, and doesn’t have to be the activation team. It could be a PI. It could be your you know your medical director. It could be anyone that has those relationships. Fostering those relationships, making sure that we can build on those relationships. We do find that the sponsors have the same goal here. They want to activate quickly, and all the PIs and all the stakeholders want to activate as quickly as possible, but collaboration and communication is key. Needs to be seamless. Needs to be supportive. Identifying the challenges, making sure that we are dealing with any delays. What are the delays? Are they within our control? Are they things where we have to increase communication? Just because they weren’t successful on that individual study doesn’t mean that we shouldn’t still work on them for that next study. Identifying key changes, request a meeting with a sponsor if you’re having consistent problems with timelines and reducing. I guarantee there’s a shared interest in reducing the white space and making sure we can activate as quickly as possible, and just a little, I think we all know this, but the quicker we activate, hopefully we’re going to reduce the number of impediments like an amendment coming through during the activation process. If we can get that initial contract executed and get that study open. We can maybe delay some of those things from impacting the timelines. Making sure we are not dealing with a transparency issue or any kind of communication. It’s very important that we are transparent on where we are with the finances, where we are in the budget negotiations, but also in the contract process. It’d be better to address those issues up front and try to deal with them in a timely manner than have them kind of build into that post 90 day or or at the very end when we’re everyone is ready to activate and we have to go back and deal with one of those challenges. 

Juliann Murphy: 

The key process improvements that we found minimizing redundant reviews, streamlining the approval timelines, the definition of clear financial approvals, who’s doing what, and then our last two big changes were we have aligned our financial bill entry earlier. So we used to have our financial bill entry after CTA execution, and then so now we have moved it to before execution. So we found that that is helping us activate quicker, and also we’re finding if maybe there’s an entry error or something before we go to contact contract execution. So that has helped us reduce our timelines as well. And the last one was we implemented a unified congruency review. For us at Yale, the congruency review has kind of been eye-opening that we improved our process. Previously, we had multiple people reviewing different documents at various times, and not all consistent. So, what we did is we assigned it to just one group of doc, and they review all the documents before contract execution. So they’re looking at the ICF, the MCA, the budget, the financial build review, and the contract, and making sure that all of those are all congruent before we go to sign off on the contract. That has helped us with reducing amendments, which is very key in our in our area, especially in Cancer Center, we had reduced our approvals and we’ve reduced our risk, and it is ultimately saving time for us. I’m going to pass it on over to Sarah. Thank you. 

Sarah Garner: 

Thank you. So to set the stage for CTMS, first our main source documents each view the trial through specific lenses: the protocol for operations, MCA for compliance, and budget or fully executed CTA for finances. Now we have to take these documents, each with slightly different viewpoints, and translate them into a system that prefers black and white with little flexibility for shades of gray. This leads to challenge number one, and will come as no surprise, as it’s been touched on already, is white space. So, as previously mentioned, when forward progress is halted pending inaction, whether it’s clarification, guidance, or resolution from an adjacent team. That’s time being added to your overall study activation timeline. So to minimize that white space, look at creating well-documented, clear approaches for translating those source documents into CTMS in tandem with proactive communication, if you notice an anomaly or a discrepancy while creating the calendar, send an email about it when you notice it, rather than keeping that growing tally and waiting until the end of your build to seek clarification. The sooner you ask the question, the sooner you get resolution. By proactively reaching out while you’re pending a response, your calendar build is still in progress with the goal of receiving an answer to your question prior to the completion of your build, and ideally your turnaround time remains unaffected. Our second challenge is that visits and procedures can be grouped or split differently depending upon the source document. So, separating the calendar build from the financial entry and completing the calendar build after receiving the MCA is a proactive approach. It is imperative that the calendar is set up for success with financial entry in order to reduce potential rework and subsequent delays at the time of final budget or when the CTA is fully executed. This is achieved by actively referencing all your source documents during the build. So, for example, if a sponsor draft budget includes visit milestones to cycle 25, but the SOA and the protocol repeats at cycle 10, it’s likely that the milestone visit structure from the sponsor budget of 25 cycles is going to be reflected in the fully executed CTA. Given this, building out to cycle 25 and the initial calendar build is setting up the financial entry for quick turnaround times by anticipating the amount of negotiated visit milestones. This is particularly important if the site does not utilize or has restrictions in place for repeating instances and open-ended functionality. Along the same lines, proactively combining or breaking out panels and bucketed procedures to align with the sponsor budget will aid in streamlining the financial entry. There is a caveat to this, that being that the designations in the MCA must align and allow for combination, meaning the designation should not be split. Speaking of, look for those split designations during your calendar build. Early identification gives you plenty of time to create and confirm those preferred workarounds. A great example would be an end of treatment visit that’s shared between two arms. Let’s say there’s an echo, and the echo is research for one arm, but a standard of care for the other. Duplicate procedures to accommodate coding can be added to the calendar build initially and upfront, which will then avoid rework at the time of coding or your financial entry. So to bring it all together, how do we accelerate activation timelines through the CTMS lens? Well, start with reducing and removing ambiguity within your process to streamline efficiency with clear, accountable guidance for how to interpret those source documents and denote your sources of truth for different parts of the calendar build and financial entry. Minimizing that white space with proactive, timely communications with well-known and well-documented escalation pathways and feedback loops. In short, know who to reach out to and when in order to avoid those lengthy delays. Also, continuously improve and level set expectations with your source documents and how they should be translated into CTMS. This consistency is going to increase confidence, going to streamline and expedite activation by standardizing your general approach. Splitting the CTMS build calendar, splitting the CTMS build into a calendar that starts after receipt of MCA and a financial entry, which can be done either at the time of final budget or when the CTA is fully executed. Allows for each component of the build to begin at the earliest point within activation. With this workflow and the calendar being set up for success. Turnaround times for financial entry post fully executed CTA are fairly quick. Even more so if that financial entry was completed with the final budget, because once you have the CTA, all you need to do is a really quick congruency review to just ensure that nothing changed between budget finalization and CTA execution, and lastly, utilize living documents. So, especially for those workarounds and any sort of accepted approaches to really complicated protocols, you’re guaranteed to see them again eventually. And these are living documents, which means as you continue to define best practices, these can be updated, shifted, and molded into what is most useful to you in the current state. So, all of these small things can add up to be significant reductions in time, and every day counts, especially when we remember what’s waiting on the other side of study activation, which is our participants, ultimately extended study activation timelines delay access to potentially life-saving critical new therapies. Health can deteriorate rapidly. A participant who would have easily met eligibility criteria three months ago may or three months from now may not meet criteria six months from now. This increases anxiety and stress, especially for participants where standard therapies may be exhausted and a clinical trial is their best option moving forward. We also have groups of patients and participants who would have forgone conventional care to take part in the trial, they may become frustrated with repeated delays, lose motivation, and just decide that they’re no longer willing to participate. And finally, discrepant CTMS coding and entry can result in unexpected bills and the addition of financial stress onto your participants. So with that, want to make sure we have time for questions. So I’ll pass it back to Jess. 

Jessica Thurmond: 

Awesome, thank you so much, Sarah. We had a ton of great questions actually come in from the attendees as well as ahead of the session and while everyone was presenting. So I’d like to jump into getting some of those answered. So, if our panelists want to come back on camera, you know, I want to start. One, a few questions came through that are looking. I mean, this is an enormously complex process for a study startup, right? And we talk about white space and handoffs as being a challenge. And on the flip side, we have some questions asking about how do you manage this when you’re working with a vendor, right? When you’re dealing, you know, in in your case, working with us at WCG, that introduces more handoffs that you’re kind of having to proactively manage. And how do you do that successfully? I can say from my end, I think there are three parts that I’ve really enjoyed working with the Yale team, and one of those is the leadership at Yale is incredibly invested in you know ensuring that timelines are activated, that they’re holding people accountable internally and supportive. So I think that’s really critical. The other was around you know looking at kind of communication. You know, Adam, we talked about this where oftentimes when people think they’re outsourcing something like this, they think it’s just hands off, right? It’s a transactional type thing. You don’t have to do anything past that point. And in fact, there’s an enormous amount of coordination. I mean, we’re meeting weekly, monthly. We have governance on a quarterly basis to meet with leadership, and that’s where the data piece comes in. And I think some of the questions that came through were, how are you guys looking at data at Yale to be able to use dashboards to inform your decisions? You know, and then on the flip side, I think one of the interesting pieces of that is us using our data together, right? Like we’ve looked at the data that we’re looking at WCG in terms of what we are able to manage, as well as in combination with your data to look at a bigger picture of where things are going wrong, so Adam and Julie, I would love to hear from you guys. You know, how do you use your dashboards internally or your data internally at Yale on a regular basis when you know working in the study startup process? 

Adam Roshka: 

Yeah, so I think there’s and there’s really we look at them in two ways. So one, Julie and her team, and I’ll let her speak to this in a second. But she looks at the budget data specifically because she is one of the process owners. So there’s that piece where we are doing it one as a process owner, and then as a process owner, but also as the as a leadership group, we look at these and look at the whole process. So we have a wonderful team. We actually have individuals and staff dedicated to managing. We call them clinical trial project managers, and we have a team that’s dedicated to managing the activation process, both on new study start-up, but are also in amendments. They are key to helping us stay on target and stay on task, and they do a lot of the work to fill in the, you know, to let us know where the process is by filling in task lists and filling in, you know, those reports that help us get the data, and then we will review those. And I think, Jess, you said at best two things have to happen. One, you have to communicate, and two, there is this, there was this alignment on the data timelines and where we start and where we stop. So, you know, even WCG will present the data, and it’ll be slightly different than our data because we’re starting at a different point or looking at it at a slightly different way, or we might be including more touch points in that data. So it’s really important to align your data and to have a similar understanding of it. And Julie, I don’t know if you want to talk about the actual process with budgets. 

Juliann Murphy: 

Yeah. So on the budget side, WCG we use their WCG system to roll out a dashboard. So I look at that three times a week. I put it into a Power BI to get a very high level from my standpoint to see where budgets are, timelines, where we’re sitting in our certain buckets, and then our team looks at it as on the more detailed level with all the notes to see if they need to push anything through with escalations, and we use that dashboard to drive our weekly meetings with the WCG budget team. It’s been very helpful, 

Adam Roshka: 

And I’ll just add there. Sorry, Julie. I’ll just add there that didn’t all that wasn’t all seamless in the very beginning. We worked really, really closely together to get the way we get the notes to change where we might a field might you know be presented, so that when we would get the data, we can get. The whole goal is to get the data to get to analysis as quickly as possible. How do we get to the brass tacks and understand exactly where we are in that process and where we need to escalate? So, I think Julie mentioned in her in her in her presentation, what’s the sweet spot of escalation? When are we losing economies of scale? We’re not making any room headway. We’re actually losing money by continuing to go back and forth, and we don’t actually gain anything. How do we get to that that decision as quickly as possible? And these dashboards and these processes help us with help us do that. 

Jessica Thurmond: 

Yeah, absolutely. I think. Sorry, go ahead, Julie. 

Juliann Murphy: 

I will have to say we did what Adam said. Like, you know, I would go to Brad with questions. Can you change this? Can you change a field? And I mean, he always said he would do it. They would figure out a way for us to be able to pull that data that we could get a comprehensive view rather quickly. 

Jessica Thurmond: 

Awesome. I think the you know you said it yourself. Continuous improvement is kind of the name of the game, and we talk about this internally as well, where there is no destination, right? You’re never going to arrive. You are never going to get there because this industry is always evolving and changing. And so, right when you think you have it down, something else is going to pop up that you kind of need to adjust. While we’re on the topic of budgets, though, that this is an interesting one: how to address volume changes and budgets and contracts when you have a fixed staff. I’m not sure if anyone wants to take a stab at that 

Adam Roshka: 

One. Oh man, I think I hate to say it, but communication. So prioritization. You know, those are two key things, right? So if you are fixed, if you’re not able to, you know, if you’re, if you’re, I would hope that this isn’t a constant volume change because if it is, then you definitely need to look at your, you know, your staffing metrics and staffing ratios, and hopefully there’s a way to do that. But if it if it’s a you know episodic you know change, I think communication. You know, getting leadership to you know understand what’s the prioritization. How are you? How are you planning? I think you can advocate for yourself, right? How are you planning to address it? How are you trying to plan to meet the timelines? What is the impact of these? Hopefully, you’re already you’re working on them in all different categories and timelines. Doing a deep dive to understand. Okay, which sponsors do I know I can get this? I have prior work. I have rate agreements. Which ones can I get out the door quickly? You know, reprioritize and shift your focus, and above all, communicate. I most of the time we find that leadership is extremely engaged, and and I shouldn’t say most time, all the time. They’re extremely engaged, and they want to again make this work. And understanding, and it’s better to tell you today that we’re going to have a problem with the timeline than after the problem has already, you know, boiled up. 

Jody Ingebritsen-Howe: 

That’s what I would. I would just say that too. And I think this actually kind of ties back to the last answers is that we worked really hard to figure out what pieces of information Yale wanted for those escalations, and that was like Adam said that was a really collaborative effort for you know your entity for whoever you know you’re working for figure out which you know which pieces of information the departments or whoever is making final decisions really do want to be pulled out? What context do they want so they can make informed decisions as fast as possible? They might not need to know every single cost that’s being thought about in a budget, especially if you’ve got five that are all priorities that all need to finalize on the same day. God forbid you get them all at the same time, and they all figure out which department, what piece of information need to be elevated for each of those per department, so that you can provide them with exactly the context that they need to make those decisions. 

Jessica Thurmond: 

Dirty one. So we have a little bit more time. Topic that’s come up repeatedly in the questions and will probably be no surprise to anyone here, but there are some challenges with sponsor responsiveness at times, and you know, getting back in a timely fashion. I know we’ve spent an enormous amount of time talking about budgets, you know, and how to handle this. You know, how do you? What are the? What’s the right timeline for those escalations? You know, and at what point do you start? You know, making a judgment call on whether you know this is worth really extending timelines. And are like you kind of said, Adam, we looked at this of you know, if you’re spending four more weeks negotiating a budget, are you really getting more money that really is going to be impactful. So I would love to open this up to everyone. Like, how do you feel? You know, we can best mitigate when it comes to the sponsor turnover and challenges and CROs that we’re facing when it comes to negotiations. 

Adam Roshka: 

So obviously, obviously, I’d say one thing. You know, this question of when do we escalate, I think we have to make sure we’re escalating as soon as possible. And what does escalation mean? There’s different types of escalation, right? There’s, I think, we talked about this just the other day at Yale. You know, there’s just including. You know, some people think that escalating means just including somebody on an email, or you know, I think you have to define what it means to escalate and be very pointed in the escalation. There’s little escalations, and then there’s big escalations. So I think if you’re stuck, you know, obviously, you know the goal is that you have a. I know this is complicated with sponsors, right? Who do I go to as a sponsor? Who can I get a response from, and who has the authority to escalate and to and to get those things moving? Hopefully, you have a. You know, if you have with your big sponsors where you have enough of a critical mass, you have a liaison that you can work with, and that you’re engaging with, and I would suggest, and I’m sure the sponsor will be willing to do this, have regular meetings and regular discussions. Our leadership does that at Yale with some of our key sponsors, so you can use that time to explain the issues and explain what you’re dealing with, but that’s not going to help you on that individual study. So I take a, I cast a wide net, and we include everyone. Everyone’s welcome to the party. It’s a good time, right? So, get the PI involved. Get find out do they have a better contact? You know, reach out to you know everyone on your study team. Who are you working with? Who’s been responsive? How do we get you know a response on this? Can we escalate it? The more people that get involved, the quicker you know, the more likely you are to get an answer, and again, hopefully you’re having. We also have stakeholder meetings where the key process owners meet. I think it’s twice a week now, where they are meeting to discuss all the steps in the process. It comes up there, and that’s where there’s you know, a bunch of different people are on that call, and stuff gets resolved there, and contacts get addressed there, so I think communicate, talk about it. You should have regular meetings. This is really important, and timelines are really important. And we’re seeing success, right? If you open quicker, your the study is more likely to be successful for you for your site and for your patients. 

Jody Ingebritsen-Howe: 

I’ll add too that as far as you know, notify everyone as early and as often, and elevate all of that. When it comes to the actual individual negotiations, drilling into those services a little bit more, when there’s staff changeover on the CRO and sponsor side, one way to avoid somewhat mitigate unnecessary delays is as you know when you provide your red lines on a contract or the initial you know budget red lines. Provide as much justification as possible for why you’re asking for the edits you’re asking for, so that if there’s a change in staff at the first round, and someone’s like, okay, I didn’t you know I didn’t get the email that had your edits in it. Sorry that so and so left or they’re on vacation. Can you can just send them? It has all the justification. There’s not a loss of a round with, you know, the sponsor, the CRO asking, hey, why do you need these edits? Why do you need these edits? You just provide it up front as your standard practice. Then you don’t have to have that wasted time, and it helps if there’s staff changeover. I would say too, just you know, if you find out, find out that oh hey, there’s a new sponsor contact here, send them your latest edits right away. Don’t wait for them to ask. Just send them. Hey, here you go. Here’s where we left it off. This is what we were talking about. Let’s set up a call if you need to wrap your head around what’s going on. Be as proactive as possible about, you know, the status of the actual negotiation right now, and that should go a long way too. 

Jessica Thurmond: 

Thank you so much, Jody. Unfortunately, those are all the questions we have time for today. But I would like to take a moment to thank Adam, Julie, Jody, and Sarah for a fantastic presentation and for sharing all of your expertise with us today, I’d also like to thank all of you, our audience members, for joining us today. And we hope you will join us again for future WCG webinars. Thank you so much to all. I hope you have a wonderful weekend, and we will see you next time. Thank you.