Reading time: 4 minutes
Goal: Tips for more accurate budgeting with clinical trials
Accurate budget management for global clinical studies.
It’s a common problem and an ongoing day to day challenge. What is? Managing accurate and effective budgeting for global clinical studies. With this article, we would like to leverage some tips and tricks we see our clients used to tackle positive or negative budget variances and how we as Clinichain facilitate with any challenge that might occur along this journey.
1. Be aware of fluctuation
Challenges occur most of the time straight after the budget is finalized and when the trial begins. As we are all aware, a clinical study normally doesn’t stick to it’s set time frame. Meaning, it could be delayed or run overtime. Did you know that only 10% of trials are finished on time? The other 90% is paying up to $35,000 extra per day, per trial. Factors of this delay could be an increase in sites, subject and site recruitment, delays on the logistics part while dealing with different geographies and many more. This could result in a changed total projected budget overtime. As a positive or negative budget variance can bring pressure on transparency of the clinical budget, Clinichain will support you and your team, setting the most accurate budget. How do we do this? For example, if we are looking at the rental of clinical equipment like freezers and centrifuges for global clinical studies, Clinichain will make sure there is an annual expected price change in logistics and equipment service projected in the budget. This will help you to always offer a transparent quote without unexpected cost during or after the study.
2. Expect the unexpected
As mentioned earlier, clinical studies are complex and have many variables, which in many cases result in unexpected situations. Make sure you think about a subject drop out, study staff that can change, patient recruitment delays etc. What are the positive of negative budget variances when delays or extensions of your study are suddenly arising when setting up your initial budget? Clinichain is able to support you with unexpected situations like this. Why? With our flexible rental solutions, we can provide clinical equipment whenever you need these. If you choose for this flexible solution upfront and a study ends earlier than expected, you can end the rental contract every month.
3. Patient recruitment and retention
Patient recruitment and retention is one of the most important aspects in a clinical study and requires resources. This includes staff time, generation of recruitment materials and investment in advertising via different channels to enlarge the awareness of the targeted demographic. Besides retaining your patients can be just as difficult, however not less important as this can lead to inadequate data and thus a more expensive trial. It’s very important and crucial to have a plan. Strategize first before you come into action. Evaluate your time, resources, and data gained from the last trials to revise your mistakes in order to tackle them upfront. It might help to ask yourself the following questions; how accessible can our patients reach our sites? With or without a disability? Who is our ideal candidate, what motivated him/her to participate etc. Clinichain does not yet have a direct impact on this challenge, however we see an upcoming trend moving towards more home trials. Stay close to us for more information on how we see this evolve and match our service due to changing defiances in the industry.
4. Helicopter view
Foresee every single step of a process in a given protocol. Here an example; You may have budgeted analyzing samples from a test kit. To do this you need to produce the kits as well. What we would recommend is to charge the given test separate from analyzing the samples. It can be helpful to organize the project budget in a time line format, considering every single activity or service and which party is involved, related to which charges. This will result in a better overview per single service and who is responsible. How we organize this: When we set up a budget for kit packing and clinical supplies for a clinical study, we collaborate together with the central lab which analyses the samples. Together with the central lab, we make an overview of the total budget to monitor the entire kit project for the bio tech company for a complete transparent budget. This will lead to greater clarity and budget transparency throughout the business.
5. Explain the difference between direct and indirect costs.
Make sure you classify your business expenses by making a difference between direct and indirect costs. Only then you get the best overview of your ‘fully-loaded’ costs.
You can make a distinction between direct cost per patient per study conduct costs, such as patient study assessments and reported outcomes, investigator and coordinator fees and more, or direct fixed costs per study level cost, such as personnel (internal and external), site, clinical supply cost, printing/paper and data costs. Then we also have our fixed indirect costs, time (upper management), facility overhead, administrative fees such as staffing, legal, financial, record storage and other. Clinichain supports ongoing while creating a transparent and flexible budget for your upcoming global study. With our Equipment Delivery Budget we make sure our clients are not dealing with any unexpected costs during or after their study.
Feel free to contact us for more information.