Why modern clinical trials need a finance-first strategy (Sponsored)

Introduction to Clinical Trials

0:00You're listening to a sponsored episode of The Top Line.

0:10Welcome everyone. You're listening to The Top Line, brought to you by Fierce Biotech. I'm your host, Kelly Hogan. Clinical trial success depends on strong partnerships, operational excellence, and the ability to navigate increasing complexity across the research ecosystem. Yet behind every study are financial processes that can either support efficiency and collaboration or create unnecessary burden for sponsors and sites alike.

0:42Today, I'm joined by Zizi Ghadar, Senior Director of Commercial Strategy for the Clinical Trial Financial Suite at IQVIA to discuss how organizations can strengthen these critical functions and build a more seamless experience across the clinical trial journey. Zizi leverages over 17 years of diverse industry expertise, encompassing delivery, finance, operational effectiveness, and the commercial sector. Welcome, Zizi. Would you like to share any more about yourself with our

1:14audience? Thank you so much for the introduction, Kelly. It's really great to join you today. As you mentioned, I've spent the last couple of decades, admittedly, in the industry from delivery and operations to finance and commercial strategy. And I often say that my career has really been about connecting dots that don't always naturally connect. And you can imagine in clinical trials, those intersections are exactly where a lot of friction shows up. From that perspective,

1:48it really led me to focus on less appreciated, but incredibly impactful, in my opinion, areas of trials. And those are the financial processes that underpin nearly every step of a clinical trial. I like to put it very simply when I'm explaining what I do. And that's that I work with organizations to modernize what has traditionally been a fragmented and highly manual part of clinical trials today. When you get that foundation right, then everything else has a better chance of succeeding. And that's

2:23been quite meaningful to me.

Clinical Trial Finance Modernization

2:25Excellent. Well, again, it's great to have you here today. Let's dive into our first question. For years, many sponsors have managed trial budgeting, contracting, forecasting, and site payments across disconnected systems and handoffs. What has changed to make clinical trial finance modernization a why now priority rather than something organizations can continue to defer? I appreciate the question. In my mind, I equate this a bit like running the latest apps on a very old

2:59phone, which I have certainly been personally guilty of. You can technically make it work, right? Everything is a little bit slower. Things can crash and you spend more time troubleshooting than actually getting things done. So at some point you realize it's not sustainable anymore. In this case, we're talking about clinical trials. We're talking about site success and patient engagement. And we're talking about retention and time to market. So cracks and disconnected financial processes are really no

3:29longer manageable. They're a direct risk to study performance and study success. If I focus on a few specifics of your question, we know and we continue to see trial complexity increasing. We talk about this quite a bit from my QVL lens in the market. That means more sites within each trial. It means more countries. That complexity is growing. We have more advanced therapies. And that translates into a much higher volume of financial transaction and constant change in budgeting, in contracting, and in payments,

4:06etc. Secondly, I think about the fragmentation of systems and how that's a natural bottleneck. So when budgeting and contracting and payments live in separate tools, you create duplicate data entry, for example. You create limited visibility delays that will ripple across the entire study. And what I have seen industry-wide is that there is a big shift, particularly with site expectations. So site

4:38expectations have fundamentally changed over the years. Sites are under financial pressure, timely payments and paying fair market value to sites, negotiating terms quickly with sites, activating sites quickly. These are no longer nice to haves. They directly impact whether sites choose to work with a sponsor or not. And finally, I think from a broader industry push, and I know that this is a hot topic item, is speed, right? That push towards speed, data-driven decisions, AI-enabled operations. But you can't

5:14fully unlock those capabilities if your data systems are siloed, right? So when you aggregate all of this together, modernizing in this space, it isn't just about efficiency. It's about enablement. And how do we enable faster trials? How do we enable more predictable trials and maintaining very strong site partnership? That's what's really moving the needle. Many organizations recognize the need to modernize, but making the shift from spreadsheets or point solutions to a more connected approach

5:47isn't always straightforward. What signals of operational readiness indicate a team is well-positioned to successfully manage this transition. This is an important point because recognizing the need is very different from being ready to act on it. And we certainly have many conversations with our sponsors about this as they come to us to solve these problems or work with us in partnership to solve these problems. My first observation is alignment across functions. So when you look organizationally in

6:21a sponsor's horizon, landscape, organizational structure, look at clinical operations, finance, your various IT and innovation partners, they need to all recognize that these processes are interconnected, that these aren't just handoffs. And that's a big indicator to me that an organization is ready. When you have typically siloed business units and functions that are coming together to recognize we need an interconnected orchestrated system and that it is siloed and they're ready to make a

6:54change. So if each group is optimizing today individually in silos, it becomes much more difficult to transition to a connected model. Awareness, of course, again, is key. Is there an awareness and a visibility into the problem? Does the sponsor recognize what the problem is? Teams and organizations that are ready usually have a clear understanding of where their friction is, whether it's delays in site payments or it's lack of their ability to forecast accurately or heavy manual burden within their

7:28operations. There is a shared awareness that creates a sense of urgency and it helps prioritize the shift. And there also needs to be a willingness amongst those groups and those decision makers to standardize process and let go of some of the traditional or historic, if you will, quote, we've always done it this way. So we need to move away from that kind of a practice and mentality and move towards that willingness to standardize. Moving to a connected approach isn't simply about technology.

8:01It requires simplifying workflows, aligning on data and definitions, and willingness and recognition is key for change. Lastly, what I've seen as a necessity for change is to have executive level sponsorship, right? That's quite critical. So these transformations within an organization, they touch multiple parts of the organization. So having leadership that views and recognizes financial operations as a strategy and as being strategic, not just administrative,

8:34it makes a huge difference in driving the adoption. Several great points. Thank you so much for that. Now, in your opinion, what are the two to three most common pain points study teams face in financial management? And what underlying dynamics are driving these challenges? Yeah, it's a great question. And there are a few that come to mind. First is a lack of real-time visibility into financial performance. We hear about this often when we survey sponsors, when we talk to sites and even

9:09participants, right? One of the top pain points that comes back is the lack of visibility in general across financial management and particularly to sponsors. So teams are constantly asking, where are we against our budget? What has or hasn't been paid? What's coming next and the predictability of what's coming next? So the challenge is the data, again, is often spread across siloed systems or sitting in spreadsheets somewhere. It's fragmented and the financial data isn't flowing in sync with

9:41clinical operations. Additionally, you tie in unpredictable site payments or delays and friction in site payments always surface as a pain point. Again, a top pain point for our sites. It's really tangible. It's a really tangible point because it directly impacts site relationships. So this will undoubtedly cause tension with sites and sponsors and sites and CROs. Payments depend on multiple triggers. You have visits. You have milestones that you're managing, invoices and approvals. You have the

10:16consumption of EDC data, what has or hasn't been contractually agreed to in our CTAs. And all this comes back again to the management across a disconnected ecosystem or process. So delays and errors and manual follow-ups are all repercussions of this. And third, that comes to mind, I would call out, is constant rework in budgeting and forecasting. Trials are inherently dynamic. You have protocol amendments

10:46and clinical trial amendments at the site level. You have enrollment changes that you're managing. Country shifts throughout the trial. And every single change forces the team to go back and adjust budgets, adjust contracts and forecasts. Without a connected system, that becomes a very manual, iterative process. The underlying issue is that most financial models simply weren't designed to adapt in real time to how trials actually evolve. Those are the most common pain points that we discuss with sponsors and sites alike.

11:24There's been significant discussion around making trials more site-centric, yet financial processes, especially payments, remain a major source of friction. From your perspective, where is the disconnect today between site needs and sponsor processes? And what does getting it right look like in practice? I have a lot of thoughts in this space. In my mind, this comes down to a fundamental mismatch between what may be optimized or prioritized a sponsor level historically. That's control, it's compliance,

12:01it's internal workflows, right? Things like invoice validation that are important, approval chains, budget governance. But from a site perspective, when you're looking at the end user and ensuring that a site is successful, what matters most is really, really simple. It's clarity, predictability, and getting paid on time, right? That's quite important. So if we look at the way payments are triggered again, for example, sponsors often rely on invoices or internal milestones while sites are

12:35operating based on patient visits and the actual work performed. And when those two aren't tightly aligned and clear and visible to a site, it creates delays and confusion and creates a lot of unnecessary back and forth. We touched on lack of transparency a bit already, but to reemphasize from a site lens, they don't always have the clearest view into what's been paid and what's pending or why something may be delayed. So they end up chasing the sponsor or chasing the CRO for updates. And this just creates

13:08administrative burden for the sponsor, CRO, and the site. And honestly, what we see when this repeats over time is just a complete erosion of trust with the site, with the sponsor, with the CRO. I think another significant disconnect ties to something we often hear from sites about, and that's inconsistency across studies within a single sponsor. Sites are juggling multiple trials, as we know, and within each of those, there's a different process, a different system,

13:41a different requirement. So even if they're encountering perhaps one sponsor might be efficient, but the overall experience for a site, it feels very fragmented and difficult to manage in the space. So when I think about what's the perspective of getting it right, what do we need to move towards? And certainly from an IQVL lens, this is something we take very seriously, right? Site success is trial success. So we need payments, for example, that are automated and event driven. So they're

14:14triggered as the work is completed. We need that real-time visibility that I mentioned is a pain point where sponsors, site, and even participants can see the data and they need the status and the updates. It's all very, very visible. And it means at least within the financial management realm, creating a consistent, predictable process across the life cycle so that sites aren't constantly having to relearn how to work with each stage. Again, great points. Our final question for today,

Building a Business Case for Improvement

14:48when sponsors build a business case for improving financial management beyond hard metrics, what outcomes tend to resonate most? Smoother operations, fewer handoffs, increased audit confidence, or a more predictable experience for sites? In my experience in working through this with our partners, what really resonates goes beyond the metrics, right? It's the shift from friction to flow, as I would describe it. Leaders care about more simple operations with fewer handoffs, predictability

15:24for both teams and sites and confidence in their financial data that everything is accurate. It's traceable and audit ready without additional extra effort. Importantly, it's about creating a more consistent, a reliable experience for sites because that directly impacts execution. So while I know and have experienced certainly that ROI and cycle times definitely matter when you're building up a business case and actual dollar savings definitely matter, what really lands is a more seamless, predictable,

16:00and scalable operating model across the entire trial. And when I allude to predictability and confidence, I mean that in the sense of a sponsor and a site position. When a sponsor can step back and say, we know what's happening within our trial. We have full visibility. We can account for our financials and our sites know what to expect. That's pretty powerful. And it shifts the experience from a reactive one to a reliable one. So that has obvious impacts on both execution and relationships.

16:33And while we may not be able to quantify as we're working through a business case, stronger relationships with sites, what you can quantify is the financial impacts to the loss of the site during a trial or sites not engaged in your trial, sites not recruiting for your trial due to the challenges that we've been discussing. And that ultimately equates to dollars' time and the potential of bringing drug to market successfully. Zizi, thank you so much for the opportunity to explore this topic with you further today.

17:04And thank you to our audience for listening to this episode of The Top Line. Once again, I'm your host, Kelly Hogan, and that's the bottom line from The Top Line. Thank you.