Smarter Forecasting for Clinical Trials: Lunch & Learn

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Maria Abouseif (Condor): Good afternoon and welcome, everyone. My name is Maria Abouseif, and I'm the VP of Sales and Partnerships here at Condor. We're thrilled to have you join our Lunch and Learn webinar on smarter forecasting for clinical trials. I'm joined by my colleague Emily Goldman, our Manager of Clinical Finance. Emily, do you want to introduce yourself?

Emily Goldman (Condor): Thanks, Maria, and thanks everyone for joining. My name is Emily Goldman and I'm a Manager of Clinical Finance here at Condor, sitting on our services team. I work closely with our customers throughout implementation and their use of Condor beyond that.

Maria Abouseif: Thanks again to everyone for joining. We're excited to share an interactive agenda around the new enhancements we're bringing to market for smarter forecasting, what we're hearing from the market and from the sponsors we support in terms of challenges, and how we're helping them unify accruals, forecasting, and budgeting.

We'll spend the majority of the time on a live demo of the platform, so we really appreciate your attendance and engagement, and we're looking forward to your feedback. We'll start by highlighting how we automate accruals on a single trial, just for illustration. Then we'll go into forecasting, and then we'll spend some time on dynamic scenario modeling, which is generating a lot of excitement - being able to model different scenarios as a trial progresses, whether that's adding sites or improving enrollment, and see in real time what the impact is on both timeline and budget. We'll end with a short Q&A.

Throughout the demo, if you have questions or comments, we welcome the engagement. You'll see a chat button at the bottom of your screen. Put anything in the chat or the question box and we'll get to your questions toward the end, and we'll make sure they get answered.

Without further ado, a quick icebreaker. If you're from finance, accounting, or clinical operations, can you describe in one word what your accrual and forecasting process looks like today? How does your team handle it - manual, reactive, automated, Excel? Please don't be shy.

All right: manual and Excel. Anyone else?

That's pretty typical. We see a lot of sponsors still managing this in Excel, or in disjointed systems, or a mix of both.

Let me start by outlining some of the challenges we're hearing about from sponsors. One is data limitations. Excel is prone to error and it isn't consistent, and it gets more challenging as trials progress and as scope changes come in through protocol amendments or change orders. It's hard to keep everything consistent in Excel on both the accrual side and the forecasting side. It becomes incredibly difficult to model questions like, what if we wanted to accelerate this program? What if we wanted to add more sites? And it's hard to be sure you're aligned with the life-to-date expenses actually being accrued in real time.

Contracts with CROs and vendors are getting more complex, and protocol design is getting more complex. You're probably managing a lot of diverse vendors, whether you're fully outsourced, running FSP, or a mix of both. There are a lot of vendors to track while ensuring accuracy and compliance.

The fourth area is investigator payments. We get a lot of questions about how to get better visibility and transparency into investigator grants. Whether you're relying on a CRO or paying sites directly, it's getting harder to keep accruals and forecasts accurate.

So how do we address those challenges? A little background on Condor. We're a leading R&D financial cloud, purpose-built for clinical trials by industry experts, to automate the whole process across accruals, forecasting, budgeting, and benchmarking with end-to-end consistency. Our mission is to help sponsors deliver treatments to patients faster, and to let teams focus on trial execution rather than manual data entry.

With Condor, we unify siloed data sources. Once you have the financial and operational data in one system of record, we layer on automated intelligence for accruals and advanced forecasting and scenario planning.

We often get asked how this works. You'll see it in the demo, but at a high level there are inputs, calculations, and outputs. On the input side, we ingest your data sources through integrations, API, or file-based support: your contracts with vendors and CROs, your CTAs, and whatever system holds those contracts. Then we build the assumptions. We take a methodical approach and build out your schedule of assessments, your program timelines, and your enrollment assumptions, and then bring in data from your clinical systems such as EDC and CTMS, as well as your ERP and procurement systems. As clinical activity progresses, the platform intelligently calculates a life-to-date expense estimate.

From there we can do all sorts of things: generate a journal entry, produce automated and accurate accruals, and feed that into dynamic forecasting and scenario modeling. We also have built-in capabilities for SOX compliance, change order management, and vendor oversight, giving you the strategic insight to make decisions.

So what's the value and impact our sponsors and life sciences organizations are seeing? There are three areas we serve, and we improve cross-functional collaboration across those three teams: accounting, FP&A, and clinical. All of those teams are part of this process, whether on the accrual side, the financial side, or managing a budget from a clinical program perspective.

A few metrics. We're seeing over 70 percent improved efficiency compared to Excel and manual spreadsheets, which lets you scale your pipeline faster without adding headcount, or shift headcount toward more strategic work. Because we've unified accruals and forecasting, we're seeing sponsors go from very large variances to over 90 percent forecast accuracy, with better visibility into cash spend and faster decision-making. The third area is clinical operations and outsourcing: the ability to track vendor spend in real time. That gives you leverage in negotiations, the ability to flag variances, maximize savings, and provide better oversight overall.

Let's jump into the demo outline. As a reminder, we're going to take a bird's-eye view of an oncology trial demo, so we'll dive deeper into one program and one trial as an example. I want to emphasize that the platform has a very modern architecture. There are configurations that roll up at a program level and an affiliate level, it supports multiple programs, and we've supported hundreds of trials of all complexities and sizes, agnostic to therapeutic area, indication, or phase. A lot of what you'll see here is at a granular level, but the configuration is flexible according to your team's needs and business requirements.

In the demo we'll cover three things. One, how we automate and streamline your accrual estimations and take you out of manual spreadsheets. Two, how you can track vendor and CRO actuals versus forecasted spend. Three, how we help you manage a program budget and dive into three different what-if scenarios covering enrollment delays and site mix changes, where you'll see the impact on trial budget and timeline in real time.

With that, I'll hand it over to Emily for the demo.

Emily Goldman: Thanks, Maria. To recap a little of what Maria just shared, what we're looking at in Condor today is an individual trial - an oncology trial - and we'll walk through how your contracts are configured at a high level and how that feeds into forecasting.

We have two modules in Condor: accruals and forecasting. Accruals is our model based on defensible and measurable study activity. On a monthly or quarterly basis, you input a few sources of data to generate your automated expense estimate, you reconcile, and your actuals in Condor form the baseline for forecasting. Because we tie directly to study activity, you have very defensible, measurable actuals to base your forecasting on. We also have comprehensive architecture for your accrual methodologies that we carry forward into forecasting, for auditability, adjustability, and to model as many scenarios as you'd like.

Here in the accruals platform, at a high level, we can look at your trial spend. Can everyone see my screen?

Maria Abouseif: Yes, we can see it. If anyone has any questions, please let us know in the chat.

Emily Goldman: Wonderful, thank you.

The basis of Condor comes from your study contracts. We load your CRO contract and any other clinical or third-party vendors being managed outside your CRO - labs, insurance, recruitment vendors, for example. There's a lot of flexibility built into the software that lets you get very granular or stay very high level with those contracts, whichever you prefer.

We also load in your site contracts. Again, at a very granular level, we can pull in your individual CTAs, the costs per visit, your admin fees, and procedure costs. We can also roll that up to a higher level and work with averages for larger studies.

Digging into the CRO, which is obviously a very big component of most study budgets: we load in your contract assumptions. That includes your timeline, how many patients you expect to screen, enroll, or complete in each region, how many sites you expect in each region, and how long you expect sites and patients to remain active on the study. This comes directly from your contract, and we configure it for you as part of your implementation. Your CRO budget is then broken into direct fees, pass-throughs, and investigator fees. Let's look at direct fees first.

Here is your actual study budget loaded into Condor. Each line in your budget gets a line in Condor, and we've ingested all of the unit detail: the contracted unit type, the number of units, the unit price, and the total contract value.

Where Condor really shines for accrual and forecasting automation is in these activity drivers. The methodology tells the software how you want to recognize each line item as your study progresses. We can straight-line across different time frames - startup, conduct, treatment, enrollment, follow-up, closeout, overall, or a custom time frame. We can also recognize activity as patients screen, screen fail, enroll, or complete, as sites activate and close, and by patient months and site months, which follow a more dynamic curve with your active site and patient populations. We also have as-invoiced and percent-complete drivers for line items that are a little more finicky, like investigator meetings.

Once these are set, you'll start to see your life-to-date expense estimate and a percent recognized for each line item here in accruals. These methodologies also carry over into forecasting, and they're how we project activity going forward.

One other accrual component, specific to the CRO but applicable to all your other clinical vendors as well, is reconciliation. In addition to your Condor-generated estimate, we compare directly against what your CRO has reported, and that reporting gets ingested into Condor too. You'll see the variance between Condor's estimate based on your current contract and what your CRO is reporting. You can use this module to hold your vendors accountable. It's where we catch a lot of reporting errors, and it opens up conversations with your vendors with a lot of data to support you.

Another component of this section is the ability to manage change orders and work with them as they're being drafted, which further supports your negotiations and helps catch errors.

We also load in your other clinical contracts, as I mentioned, with a lot of flexibility - any trial-related contract can be loaded as granularly or as high level as you'd like. The other major component is investigator grants. We load in your site contracts, either very granularly or rolled up to regional averages, with your costs per visit, your admin fees, and any material procedures you want to track. For this oncology study we have biopsies, imaging, PET scans, MRIs, and CTs. Again, we'll work with you to determine the best fit based on your protocol and what you want to track.

That serves as our baseline for investigator grants. For accruals, we also load in your EDC data to generate the investigator grants estimate based on actual study activity. Knowing that EDC data can lag behind site data entry, we can adjust for some of that lag using our expected visits feature, which works predictively within Condor.

One more thing to touch on briefly, digging into procedures. We can generate an incidence rate, or an understanding of what has actually occurred in terms of invoiceable procedures. Thinking of our oncology example, very often there's an image or a biopsy due at screening or on a regular cadence throughout the study. For forecasting, we can use the rate we've seen historically, or project different incidence rates and mark them as a percent likelihood to occur at each visit throughout the visit schedule. That feeds into the forecasting module and lets you get extra accurate with your investigator grants estimates.

That's our baseline in terms of accruals: how we generate the actuals we forecast off of, and the methodologies we'll use to forecast. Maria, anything to add on the accrual side before we jump into forecasting?

Maria Abouseif: If anyone has questions, please chime in or put them in the chat. Emily, on this estimating capability - we hear a lot from sponsors that they often don't know. Sometimes a biopsy is optional, so they don't know how many biopsies they'll incur, and this is a way of estimating the probability of occurrence. Is that fair to say?

Emily Goldman: That's very fair to say. Generally these start with an estimate from an incidence rate. Often your clin ops team will know what procedures are expected and at what cadence throughout the study, and, to Maria's point, how much of the patient population is likely to receive them. But we can adjust these throughout the study. They're totally flexible - removable or adjustable as you get more data and as the study progresses.

Lars asked how you would account for out-of-scope units. There's a section for the current contract and one for an amendment in progress, so let me dig into that while we're still on the accrual side.

For out-of-scope units in your CRO reporting, within this Recon and Adjustments tab - looking at direct fees here - we show you Condor's independent estimate versus what the CRO has reported. We load that reporting in and match it line for line with your budget, which is how we generate the variance column.

We'll also show any out-of-scope items, and I have a couple here. These two line items for data monitoring setup and process don't have any contracted expenses or contracted line items. We haven't had any reporting from the CRO on them yet, so no activity has been incurred, but it looks like we have them in our upcoming change order.

The big value of this Recon and Adjustments screen, which I haven't mentioned yet, is that we don't just view all of these pieces of data together - your current contract, your CRO reporting, and your upcoming change order - we can adjust and book to any of them. These are relatively small line items, but you can always come in and say, I want to recognize activity from the change order in progress. That lets you smooth out what would otherwise be a pretty sizable true-up when the change order is executed, since there may be a retroactive effect. It's a very auditable process, so it's clear what adjustments you're making against the change order in progress. There's also comment functionality, which you'll see throughout the software, to document key decisions, discuss with your team, and upload supporting documentation.

Another benefit of loading your draft change orders into the software is seeing where the variances lie and whether they make sense. Does it make sense that your site management fees are increasing by a certain percentage when you aren't actually adding any sites with this change order? It lets you catch errors, hold your CRO and other vendors accountable, and open up conversations with a lot of data behind you. Out-of-scope units appear flagged with blank columns here, and the same goes for your CRO reporting.

Maria Abouseif: Well said, Emily. I'd add that this is an area where we've seen a lot of sponsors flag variances, and we've helped them save millions of dollars when a contract or an amendment came back with inaccurate reporting from the CRO or vendor. In one example, we saved almost $5 million across a handful of programs because we were able to flag variances that weren't correct.

Emily Goldman: Happy to come back to accruals if there are further questions, but I'm going to take us into forecasting next.

As I mentioned, accruals sets the foundation for forecasting, which is why we wanted to walk you through that module today. With that solid foundation and architecture, it's very easy to extrapolate expense estimates forward. And as your accruals are maintained in Condor on a monthly or quarterly basis, you have updated actuals to forecast from. Since we already know your schedule of assessments and how your contracts are driven by study activity through the drivers we set up in accruals, it's straightforward to plug in whichever parameters you need and have a new scenario.

You can create as many scenarios as you like in Condor. You can name them and organize them into folders. They're also lockable, so once you've created the scenario that will be your forecast for the quarter, you can lock it, no further changes will be made, and you can refer back to it for your budget versus actual analysis knowing it hasn't been modified.

A quick overview to orient everyone. We have a visual summary tab, and a details tab in a table format if you're more numbers-minded. We can also look at the expense grids we saw on the accrual side with the actual study budget and go line for line to see what's being forecasted, and adjust drivers in there. Then our parameters tab is where you pull all the levers and toggles to create new scenarios based on what you're modeling.

The summary tab is fairly self-explanatory. We show your life-to-date reconciled spend against your contract total. Then, based on the scenario you have, we show the forecast and whether you're over or under in terms of budget, sites, patients, and timeline.

Here are some out-of-the-box visualizations in Condor: cost and time, budget versus forecast per vendor, trial spend - that's the same graph we see on the accruals side - run rate versus enrollment, and cost per patient over time. In this particular scenario, you can see where the timeline extension shows up across all of these. If there are other visualizations you'd like, we can provide them, and all of the data in Condor is exportable in a couple of formats to support your analyses or any other visualizations or databases you use.

Digging into the details tab, we can see contract value, life-to-date reconciled, forecasted total, grand total, and overage and underage for all of your vendors and cost categories - the CRO and the other clinical contracts. That's the high-level summary. We can also see month-over-month actuals and month-over-month forecast for each vendor and cost category. On exporting, you can do that via CSV or Excel, or through a direct integration into another reporting system.

Operationally, you'll see similar data for patient enrollment: actuals month over month and forecast month over month, plus cumulative totals. The same goes for site activity, and for which contracts you're currently working with in this forecast.

At a very granular level - and this tab is completely optional - we have the option to view your expense grids and each line item in your budget. Looking at the CRO contract we just set up, here are the individual line items. We can see the activity driver attached to each one, where we are in terms of number of units and unit price, and our life-to-date spend. If for some reason there's a methodology set up on the accrual side that your FP&A team wants to adjust to see how it affects the scenario, you can adjust the driver line by line in forecasting without affecting your accrual. Then we show the life-to-date expense and forecasted total for each line, along with month-over-month actuals and forecast. Very granular - it's there if you need it, and completely optional if you don't.

Most of the magic happens in the parameters tab. We have that foundation from accruals and we can see where we are in terms of actuals - your actual enrollment rate, your actual site activation rate, your actual cost per patient. And then we can adjust all of it. Let's walk through the options for creating a new scenario, and then do some live scenario modeling.

Maria Abouseif: Emily, for the sake of others - when we say actual, do you mind shedding some light on how the platform understands that, or where we get it from? We get that question a lot.

Emily Goldman: Great question. Condor generates all of your actuals data from your study data. Your enrollment rate and site activation rate come directly from reporting that you load into the software, or that can be integrated into it. Your patient activity and enrollment rate come from your EDC reporting. Your site activity is typically your IRT reporting, or whichever site listing you're using. The software ingests from those reports when sites are active and when they've closed. We know the assumptions you're contracted for, so we can make predictions about how many sites and patients you'll activate and enroll respectively. Those rates come in out of the box, and you can adjust them from there.

You can adjust your patient enrollment curve and your site activation curve in a couple of ways. The first is a linear rate: patients per site per month, or sites activated per month. We can also do a month-over-month rate. The benefit of the linear rate is that it's straightforward and quick. The month-over-month rate is quick as well, but it lets you get more granular about scenarios that significantly affect your forecast. For example, if you want to model staged enrollment - you open the US first, then the EU three or six months later, followed by APAC - we can model that specifically. Another very common scenario: in the EU, PIs often go on vacation in July and August, and enrollment and site activation slow down. We can account for that with month-by-month enrollment and site activation rates.

Other toggles you can adjust are your patient averages: average cost per patient for visits and procedures. These can be modified if, for example, you activated some particularly expensive sites initially but will be bringing on more regional or local sites that cost less, which brings your average cost per patient down. We can also adjust average treatment length. Thinking of our oncology example, the hope is always that patients respond well to treatment. You may begin the study assuming patients remain on treatment for a certain length of time, but if all goes well and patients respond, they'll remain on study longer, which affects your budget. That's an adjustable field in forecasting in Condor. Lab costs, again as part of your average cost per patient, can be adjusted too.

Site averages are your admin fees: startup, closeout, and recurring fees at the site level, and these can be adjusted regionally.

Then we have the actual number of patients and sites. A couple of scenarios spring to mind: what would it look like if we expanded enrollment on this study and added 50 patients to the US enrollment goal? Or if we're screen failing fewer patients than expected, or more, or if more patients are dropping or fewer are dropping. All of that can be adjusted in this table. Sites can be adjusted similarly, so if you want to close out a region or shift sites across your regional breakout, we can model that - and one of the scenarios we'll walk through today does exactly that.

Then patient months and site months, which go back to how long patients and sites are active on the study, can be modified here too. All of that generates a new study timeline, along with updates on where you're expected to land against your budget for each vendor.

Forecasting in Condor is real time, so let's walk through a couple of scenarios and show you how modifying those parameters generates a brand new scenario.

There's a question: does Condor use a weighted average for calculating procedural and visit forecasted costs based on current patient enrollment? Let me answer, and tell me if I'm not on the right track, Keith. For visits specifically, we have your total visit schedule in Condor, with the cost per visit from screening through end of treatment. Based on the individual site CTA costs, since we have that level of granularity loaded in, we use the visit schedule and the cost per visit and project patients through it. So we get pretty granular there. If we're using a regional average for site costs on the accrual side, that rolls into forecasting as well - whatever level of granularity is set up in accruals flows into forecasting.

For procedures, we leverage the cost per procedure. In the parameters you can see an average total procedure cost per patient. That can be calculated using the procedures mapping we looked at on the accrual side, with the percentage incidence rate for each procedure type at each visit. It can also be manually adjusted - if you have additional information from your clin ops team or another data source, you can override it right there.

Maria Abouseif: So just to be clear, Emily, on the forecasting side we feed the actuals from the accruals module, but then the FP&A and finance teams have full flexibility to change whatever parameters are needed for future spend. That's where the different scenarios come into play.

Emily Goldman: Exactly. Keith, let me know if that answered your question. Any other questions before we dig into some scenarios?

Let me take us back to the summary page. What we're seeing in this scenario is that we're tracking over timeline and over budget. We can trace that to patient enrollment - our enrollment is slower than we expected, which is driving us over on timeline, and more time means more money.

So one scenario we can explore is the patient enrollment curve. What would it look like if we increased enrollment in the region that's slowing us down? How much money would that save us if we could reach that enrollment rate? Then we can analyze what we could afford to invest in increasing enrollment in that region - maybe a recruitment vendor, maybe more advertising. We have an enrollment rate for this region right now, so let's increase it by about 50 percent. In real time, that generates a new scenario, and now we're tracking under budget and under timeline just from increasing the enrollment rate. You can look at the delta in your expected spend and determine what the next steps would be to actually increase that enrollment rate - much easier said than done, but that's one scenario you can model in Condor.

Maria Abouseif: And can that be saved as a scenario and shared with other teams, clin ops and so on? We get asked that a lot.

Emily Goldman: Absolutely. You can always duplicate a scenario, and the scenario is automatically saved in Condor - there's no need to click a save button. Locking a scenario makes sure no further changes can be made until you unlock it.

Another scenario you could model: this region is slower on enrollment, so what if we move some patients from that region's enrollment goal into a region that's enrolling more quickly? We'd do that down here in our patient assumptions. We have an enrollment goal of 100 patients in this region versus 146 in the United States. Let's move 25 of those patients into the US goal.

We're reducing the burden on the slower region and shifting it to a higher-enrolling region. Again, in real time, we calculate a new scenario. That brings our timeline in significantly - we're now just one month over on timeline and running under budget. So enrolling more quickly here affects the forecast in a slightly different way.

Maria Abouseif: So this can be used as a tool to discuss sites and regions with clin ops. If the team wants to expand, add sites, or shift the mix between regions, you can do it almost instantly and understand the impact, rather than going through a lot of manual manipulation in Excel.

Emily Goldman: Precisely. Is it valuable to close sites in this region that are poor enrollers and reallocate resources to the more successful, higher-enrolling sites that may already have patients lined up?

The last scenario we'll walk through today: let's reset our enrollment goals back to what they're contracted for. What would it look like if we supported the slower-enrolling region instead, by adding a site to it? Let's say North America is enrolling more slowly. We'll double our site count in this region, but realistically we think we'll get fewer patients per site per month, so we'll reduce the enrollment rate we're projecting for that region while giving them another site to enroll into.

Again, we generate a new forecast. You can see the new site we added - one more than we have contracted. We've brought the timeline in from a 10-month overage to a two-month overage, and our budget is sitting just under contracted in this scenario. So that's three different ways to model scenarios for the same problem of slow enrollment. Based on the parameters we have adjustable in Condor, you can model a number of scenarios related to cost, site activations, timeline, and so on.

Maria Abouseif: And Emily, if we scroll down, all of the curves and dashboards change with each scenario. You'll see at a granular level your enrollment rate, your run rate, and your cost per patient over time across the various scenarios. This can be integrated into your FP&A system or exported into Excel or dashboards for further visualization. And all of it can be rolled up across all of your trials, so you have the flexibility to model different scenarios across programs and compare the impact of each decision.

Emily Goldman: Absolutely. Are there other questions we can address - accruals, forecasting, or Condor at a high level? Happy to take them from the chat, or we can open up the Q&A.

To give everyone a chance to type, let me give a quick recap of what we walked through. We covered the two modules in Condor, accruals and forecasting. The foundation for forecasting lies in accruals, and the benefit of that is reducing the opportunity for variance between the two modules and increasing accuracy.

A lot of what we see today at sponsors is Excel-based. We got a note in the chat that manual Excel is the current process. Often accounting is managing one workbook for accruals and FP&A is managing a second workbook for forecasts. They have to be maintained separately, by separate teams who may not always be working off the same information, and that leads to errors and variance.

This particular trial is modeled off one of our current customers' data - de-identified and adjusted a little, but real. In their experience, their prior forecasting workbook ran about a 45 percent variance to actual. After moving into Condor and unifying the source data for both accruals and forecasting, they saw a 3 percent variance to actual. That closes the gap for error and variance, and it unifies the accounting and FP&A teams around the same data. They're all speaking the same language, and you get very accurate outputs on both the accruals and forecasting side with a light lift.

Maria Abouseif: Spot on, Emily. We're trying to streamline the entire process end to end, and what we're seeing is that it improves collaboration between teams, including clin ops, and gives finance more of a seat at the table to consult and inform on strategic decisions.

Emily Goldman: Let's open it up for questions. Are there any from the audience?

Maria Abouseif: Do we have any questions, Audrey?

Audrey McNicholas (Condor): I don't see any beyond the ones Emily already answered - oh, one more just came in. How does the forecasting feature take into account the lifetime of the trial instead of just what's based on contracts?

Emily Goldman: Great question, Shin. If I'm understanding correctly: the contract assumes a timeline, but over the length of the study that timeline shifts, or time gets added because enrollment is slower or something else has changed. Very common. By loading change orders into Condor as the study progresses, we update the study timeline in line with those new contracts, generate new life-to-date expense estimates, and then generate forecasts off the updated contracts. Condor lives and breathes with your study as it progresses, adjusting based on the inputs you feed in at the contract level and the study data level.

Maria Abouseif: Exactly. It isn't just based on the contracts - we're looking at the entire lifetime of the trial. From there you can roll up across your programs and do budget versus forecast versus actual. We didn't spend much time on the reporting side, and I'm happy to share a few snapshots, but you can compare periods against each other and see the total cost over the lifetime of the trial, rolled up at a program level. Does that answer the question?

And one other question we always get, Emily: how does this work if a trial is already midway? Say we've already started, we're in Phase 2, enrollment has been running for eight months. Can Condor take all the historicals into account?

Emily Goldman: Great question. We can implement a study in Condor whether you've just signed a work order or, to Maria's point, you're already partway through. When you're partway through, we load all of your historical information into the software - what's been invoiced and paid, and all of the historical patient data. So we configure your baseline in accruals taking that history into account, and then start accruing your actuals in Condor from there, replacing a prior workbook methodology. And we have all of that historical information in accruals to forecast from, so your forecast is inclusive of the trial's history.

Audrey McNicholas: We had two more questions come in. One is on benchmarking: will there be cost per patient benchmarks for different trials, like oncology versus hematology, and Phase 1 versus Phase 2 or 3?

Maria Abouseif: I can take that. Benchmarking is dear to our heart, and we're planning to bring it into the platform very soon. In the meantime we do offer some level of benchmarking depending on your indication, phase, and so on, to help guide sponsors budgeting for new indications or phases they haven't worked in before.

We leverage a few things: anonymized aggregated data on our platform, our own expertise and advisory, and a partnership with a leading real-world data provider that has aggregated thousands of trials from various registries. We're very transparent about the source of the data, and we can come to you with a report that shows the median, high, and low across various parameters - not just cost per patient, but operational metrics like enrollment, regional variances, and total study cost.

Often we hear from sponsors that they bid out to various vendors or CROs, and the CRO underbids and then makes it up over time through change orders. We want to provide a more holistic, evidence-based approach to benchmarking and surface those insights early, as you're planning studies. If you're interested, happy to follow up and show you what we have today. And as I mentioned, we have plans later this year to bring it live into the platform, so that as you're budgeting we can surface these strategic insights at your fingertips.

Audrey McNicholas: One other question, from Keith: if I have a change order, could I put in the updated patient and site counts and use the forecasting tool to benchmark against the contract my vendor is sending me?

Emily Goldman: Absolutely. That's another part of the change-order-in-progress functionality. If you have a draft change order with an updated enrollment goal or updated site numbers, maybe with things shifted around regionally, you can put those updated numbers into a scenario in forecasting and compare the final output against the change order total. Does the delta based on Condor's estimate align with what the CRO is proposing in that change order?

Audrey McNicholas: I think those are all the questions in the chat for now, but we'll keep monitoring. We have five minutes left if there's anything else you wanted to share, Maria or Emily.

Maria Abouseif: Maybe a recap and a call to action - and if you have questions, please don't hesitate to put them in the chat. Thank you, Emily, for doing a wonderful job as always.

To recap the strategic benefits of smarter forecasting: real-time scenario planning. You can instantly see the impact of change orders and the different trade-offs you're weighing, per program, per trial, and across all programs, with the financial impact of operational changes by vendor and by study, on both timeline and cost.

Another key benefit is cross-functional alignment. Everybody is singing from the same sheet of music. Finance, clin ops, outsourcing, and accounting all work off one unified platform in real time. No silos, no conflicting spreadsheets, which we often see across teams.

Then there's strategic decision-making. As you prioritize programs or specific trials over others, and as you support mid-range and long-range planning, this is a strong tool for comparing and re-forecasting on a periodic basis, and for bringing in benchmarking intelligence - either internally, comparing your own programs against each other, or with the industry benchmarks we just discussed.

Last but not least, we all have 24 hours in a day, and sometimes I feel I need 48. It's about speed and accuracy. On the forecasting side, we're shifting people away from low-value data entry and living in spreadsheets, toward understanding the data. That lends itself to a more accurate, compliant, standardized process and gives teams the ability to excel at what they do best. We're seeing over 95 percent forecast accuracy.

We're sharing some quotes here from our sponsors and customers, whether that's savings and vendor oversight or expanding the portfolio without adding finance or accounting headcount. We didn't talk much about this, but all of it is designed with audit and compliance in mind and has been approved by Big Four auditors on the accounting side. All of that translates into what used to take weeks now taking minutes, which hopefully you saw in the demo.

As a call to action: we really appreciate everyone attending our Lunch and Learn webinar and demo. We'll follow up with a $25 DoorDash gift card for all attendees. If you'd like a custom walkthrough, or if there's something you need configured or tailored to your team's requirements, we'd be happy to schedule a one-on-one session - my information is here.

This is an opportunity for all of us to transform manual processes and help you plan, manage, and forecast your R&D spend more accurately and efficiently, so you can stretch every dollar and focus on bringing treatments to market faster. Thank you all for your time.

Audrey McNicholas: Thanks, everyone.

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