Clinical trial budgeting step by step
How to manage the budget is a crucial part of each clinical trial and needs special attention. In this article, we present to you the methodology we have created throughout the years and that we use as a basis for the development of Clinicubes CTMS.
The budget management process consists of three main phases:
- System setup and study preparation
- Budget preparation
Let’s go through these phases together with our CTO Ivailo Ivanov, the CTO of BGO Software, the visionary behind the Clinicubes CTMS
Phase 1 – System setup and study preparation
When a new study arrives, we want to budget it and create different scenarios. This is the time when we receive the documents from the sponsor and we start the budgeting process. The first step in the phase is pricelist management which requires collecting pricelist information, provided by our vendors, and by the services we provide as an organisation (some of them could be done internally, some of them – provided by vendors and subcontractors).
“The actual system setup in Clinicubes is done once – when the system is being implemented. To have the system ready to add new studies and create budgets for them, we need to import some information about the stakeholders and the people and organisations we work with. This includes research centers, laboratories, personal contacts, and other persons, involved in our ecosystem, such as physicians. Once we have this information it is important to add information about the sponsors we work with”, explains Ivailo Ivanov.
The next important step is the creation of the actual price list, i.e. the pricing we will use for the expenses parts of the budgeting. The pricelist has some dates that mark it as active and when a vendor changes the pricing we can update and import new prices. “This is important, because for some studies that takes longer (a couple of years, for example), the pricing could change over time and some payments can be made according to one pricelist, and the later payments to be made at different prices. It is quite important to have accurate data for our budget and especially – for its expenses part”, says Ivailo Ivanov.
Let’s say we have the first step done – the system setup and the pricelist. The next step is the actual study preparation and the modelling of the study protocol. We need to register the study in the system by entering the study details (study title, phase, some recruitment targets, and some basic information) but the more important part is to model the study protocol. The budgets derive from the study protocol. Once we have prepared the study protocol it’s important to mention that in some cases when we execute just parts of the study, we don’t need to enter or import all of the procedures which are listed in the protocol but only those that we are interested in and we are contracted to execute. Once we have this baseline and the so-called skeleton of the budget we can go to the next step – the actual budgeting phase, where we need to execute three steps.
Phase 2 – Budget preparation
The first step in this phase is the sponsor budget or our income component.
The sponsor budget is generated automatically by the protocol and we use it as a baseline. “What we need to do is practically input the payments, which we expect from the sponsor for each of the procedures. This is based on what is contracted and our arrangements with the sponsor”, explains Ivailo Ivanov.
Many different settings could be set on the sponsor budget. For example to track overheads, define different budgets, and also to manage cases such as when the sponsor pays you the visits and the total amounts in comparison to payments for each procedure, etc. Defining the sponsor budget is the way to create our income component and once we have it, we can move to our expenses component.
The second step is our expenses component or the actual mapping of the services and procedures which are listed in the protocol by the sponsor.
In many cases, when we receive the protocol from the sponsor and he says I’m going to pay you “X” amount for a particular procedure, this procedure rarely matches exactly the services we provide or our vendors provide. That’s why the step for building the expenses part is called service and procedures mapping. We can choose how many services from our vendor are matching to each procedure and have a quite granular way to determine the cost of a particular procedure and visit.
The third step is creating different variations and budget versions to play through different scenarios and the option to choose the budget which we mark as approved and use as a base for the execution of the study.
Once we have the income component and the expenses component, we can do the budget versions. The budget versions are different scenarios we want to try to see whether there will be a profit or not if we execute the budget in that way. The budget versions allow us to track the ongoing costs and see to what extent the budget is successful, or we are under budget, etc. There are multiple settings of the budget generation versions. “Something, which is quite important and solves the problems with the financial relationships is that we allow a complex profit distribution between the different stakeholders. There are many ways to split the payments, profits, or revenues, as the tool is quite flexible. These budgets can have limited time duration, so when we change the arrangements with the sponsor we can rebuild the budget or use an old budget as a basis”, says Ivailo Ivanov.
Once we have finished the budget phase and have gone through different scenarios we need to decide which of these budgets should be the final or approved one. Then we can start the study execution or make an offer to the people who are requesting the study from us. Here we can move to an optional phase – budget tracking.
Phase 3 – Tracking
The third phase requires the creation of the so-called site contracts and each of the research sites we work with can receive a separate budget which is derived from the main budget version. Progress tracking is the actual process of reporting the visits and activities by the site, so we can monitor the execution of the study in real-time and check whether we exceed the budget, or we are under the budget and what is the actual profitability, and the payments due to the sites.
Here we can use different tools such as generating subject plans, reporting the visits and procedures, and also getting reminders about which patient should come when and which visit or procedure should be executed, etc.
Clinicubes and its financial functionalities
Clinicubes is a cloud-based software. It’s suitable for hospitals, research sites, small CROs, site management organisations, everyone, who manages clinical trial information and wants to keep track of budgeting and study progress across multiple sites, and studies that have multiple arms, and changes in the contracting during the execution of the trial.
Clinicubes CTMS covers the whole three phases, mentioned above, via its financial functionalities:
- Easy budgeting, instant dashboarding, and reporting
- Protocol modelling tool, which guarantees an optimized management of study protocols and activities.
- A centralised study database, which acts as our central registry of studies we work on or we are planning to work on. This functionality covers monitoring of study progress, centralized collection of the documents we receive from the sponsor such as protocols, contracts, regulatory approvals, and many other things, ongoing payments, etc.
There are also many additional tools, which could be of real help to the organisation and the study, such as:
- Patient enrolment tracking, visit schedule management, and reporting
- Site management and regulatory process tracking
- Patient randomization algorithm
- Integration with other systems
Interested in learning more?
Contact us to find what we can do for you or request a virtual demo today!