Running a clinical trial is a complex undertaking that requires a depth of knowledge and practical strategies to succeed. One of the most challenging – and critical – parts of running a study is developing a clinical trial budget.

To the extent possible, your clinical trial budget breakdown needs to be accurate. Not only is this important for practical and logistical reasons, but an accurate budget indicates that you understand the scope & costs of your project to your reviewers.

In the following article, we’ll look at 5 key factors to consider when developing a budget for your study and how to best strategize for success.

As you develop your clinical trial budget, you are likely trying to strike a balance to achieve the best cost without sacrificing quality or compliance. Depending on your trial plan, your study could range from several hundred thousand dollars to several millions. Given this large window, it’s important to start working on budgets early to fine tune a solution that’s specific for your study.

That being said, you’ll want to know what factors can impact pricing for your clinical trial budget:

• Timelines, enrollment in particular, factor greatly into the overall trial budget and can vary based on the complexity of the study design.
• The number of sites used in your trial will also affect the budget as you or your CRO will have to set them up and manage them throughout the study.
• Vendors can also impact the study budget, depending on how many are needed for specific trial activities.

In the next section, we’ll look at 5 key factors that affect your total expenses and help you create an on-target budget for your clinical trial.

1. Site Costs

First, you need to consider the cost of setting up, maintaining, and closing your site(s).

While some of these fees may seem clear and upfront, others may sneak up on you – such as regulatory fees involved with the Investigational Review Board, IRB, an independent committee responsible for protecting the rights and welfare of human subjects in clinical trials.

Common site costs can include:

• Site startup fees: Site startups involve gaining consent to run the site, staff training, Investigational Review Board (IRB) submissions, Ethics Committee submissions, and site initiation visits. These costs can vary depending on the type of clinic that is running your study and what materials are required to be in place before the start of enrollment.    
• Storage fees: Clinical trial data must be securely stored following site closeout, often for regulatory periods from 2 years to 20 or longer.
• Administrative overhead includes the cost of management and legal resources needed to manage the site and review clinical contracts.
• Site closeout includes paying staff to closeout the site after the trial is done.

2. Safety Oversight

One of the most significant safety oversight costs involves the evaluation and reporting of adverse events, including reporting events to regulatory agencies, ad-hoc meetings and additional reports, and medical follow-up.

3. Data Management

Data management encompasses a broad range of activities that must be accounted for in a clinical trial budget. From start-up to close-out, data is constantly being entered and queried into the EDC platform, which requires extensive oversight and management. More importantly, data management impacts downstream operations for crafting your clinical study report (CSR).

Here are some factors to consider in data management:

• Sit through a demo of the system(s) to see how data can be entered and illustrated first, followed by a pricing discussion.
• Ask about the timelines for a database build, as these will have a financial impact on other corresponding service areas, like project management.
• Receive multiple vendor quotes for EDC platforms so that you can weigh out the cost and the study specific functionality of the platforms.

4. Regulatory Submissions

Ensuring that your clinical trial meets regulatory guidelines needs to be factored into your budget for your clinical trial.

You may find that as you dive deeper into your clinical trial, you’ll discover new required submissions; the more you educate yourself upfront, the better prepared you’ll be to budget for this aspect of your trials. Regulatory costs might include anything from filing special paperwork (such as annual reports) to registering the study on clinicaltrials.gov.

5. Pass Through and Travel Expenses

Finally, you’ll want to think about pass-through expenses that may relate to the operations of your clinical trials.

This can include expenses for:

• Airfare, Lodging, and Transportation for on-site visits
• Key study vendors, such as the central laboratory and imaging
• Clinical research sites who perform clinical conduct and directly interact with patients
• IRB fees related to study submissions

Developing an Accurate Budget with Proxima CRO

Proxima CRO can help you develop an accurate, on-target budget for your clinical trials through a partnership with one of our business development strategists. We also offer step-by-step expertise and partnership through every step of your clinical trial process, including:

• Site management and clinical monitoring to help ensure compliance and support for your selected sites
• Project management through an agile framework to deliver quick responses and accelerate delivery–ultimately saving money while maintaining quality
• Data management, offering efficient database setup for high-quality data.
• Vendor selection, qualification, and management to support complex trial components

If you’d like to learn more about how Proxima CRO can help you run successful clinical trials, get in touch with our team.