Preparing a robust clinical trial budget from scratch is a matter of great responsibility. Not only would the person responsible have to manage costs, but he/she would also have to deal with the pressure of keeping the expenses at bay.
A clinical trial budget involves several components, and each component has to get fine-tuned to ensure that there are no unnecessary costs to the company. However, no matter how many times the budget gets adjusted, there is always scope for improvement.
These enhancements can only get implemented when certain practices are followed by management. The cost varies based on the visit plan, number of subjects, planned number of sites, number of monitoring visits, site activities, etc. While the cost of clinical trials is on the rise, it has become hard for sponsors to control the costs while ensuring quality and maintaining compliance at all times.
Best Practices for Preparing a Clinical Trial Budget:
If you’ve researched for best practices for preparing a clinical trial budget, you may have encountered a wide array of advice, but one aspect remains at the top, which is – preparation. Here we have come up with a few of these practices which, when followed, would pave the way for a robust clinical trial budget.
#1. Understand the sponsor’s perspective
An important part of preparing the clinical trial budget is to understand the sponsor company’s goals and constraints you’re going to partner with. Take notes of their preferences and the areas in which they are typically flexible. Using historical data and experience, you can avoid various roadblocks that may occur during the process.
These ideas are just a few ways to help you prepare and navigate for your next clinical trial budget. With such facts and information in hand, you can put yourself and your company into a better position for long-term success.
#2. Re-forecasting the clinical trial budget regularly
When a clinical trial gets started, the first stage that comes up is the start-up and enrollment phase. Most of the managers prepare the budget for this stage on the notion that clinical sites would get activated quickly, and enrolments would get finished in little to no time. However, due to uncertainties, there can be delays due to which there can be extra costs.
These extra costs can exhaust the budget for future stages. This is where re-forecasting would become essential. Through re-forecasting, a new budget would get prepared, and new objectives would get framed. Hence, periodical re-forecasting is a good practice to make sure that you meet the research objectives efficiently.
#3. Outsource non-essential tasks
If you plan to execute every step on your own, it is a recipe for failure. You must accept that you can’t become an expert at everything, and hence you must outsource the non-essential tasks to a contract research organization.
For instance, you need to transcribe a few minutes of a meeting. Don’t carry out this task on your own since you already have more crucial matters to attend to. Outsource this task to subject matter experts who can perform this task properly. When you start outsourcing such small tasks, you would observe that you have more time in your hands, and you can focus more of your attention on core activities.
#4. Keep a check upon group travel
Group travel can cost your company a fortune, especially when a group of more than ten members is traveling. Group travel generally gets considered to be a wastage of money because most of the firms allot a very tight budget for clinical research.
So, for example, an international conference is getting organized, and it asks for more than ten members of your department to attend. If the conference can get attended virtually, the members should do so virtually. However, if the virtual option is not available, and the meeting has to be attended, instead of traveling through first-class, the members should travel through the economy class. By practicing such policies, you could save a lot of money in the long run.
Implementing these three strategies would ensure that your clinical trial budget would be up-to-date throughout the research. A clinical research budget would determine how seamlessly the research would get conducted. So, apart from these three strategies, you could also look into adjusting your clinical monitoring plan, batching your clinical trial activities, and contracting a few medicinal chemistry services providers.
All of these practices would help you and your team to achieve the objectives of the research. Also, keep in mind that all the sponsors and contract research organizations’ payments must get executed after any planned objective gets completed. This would ensure that a fixed pattern is followed in payments, and your budget gets used systematically.