An electronic data capture (EDC) system is a software application used to collect, clean, and analyze the data generated in a clinical trial. This is in fact an essential tool used to manage the data of a clinical study.
Every clinical trial sponsor —whether a biotech, pharma company or academic group— needs an EDC system to conduct a clinical trial. Then, one common question that comes to mind is: how much does an EDC system cost?
Well, there are many EDC solutions in the market with different capabilities, integration options, and prices. How much should a clinical trial sponsor pay for an EDC tool? It will depend on the type of study and, of course, the budget available.
Commercial vs. Academic Clinical Trials
One initial consideration related to the cost of an EDC system is the type of clinical trial it will be used for. Not all clinical studies have the same characteristics, and sponsors might have more or less funding to be invested in the project.
For example, sponsors conducting large pivotal commercial clinical trials seeking the approval of a drug usually count on substantial sums of money to be dedicated to technology. Then, it is common to see industry-leading EDC brands being used in multinational registration trials.
However, not all trial sponsors count on hundreds of thousands of dollars to purchase a top EDC license. For instance, independent clinical investigators or academic research groups may have less money to fund an EDC solution for their studies.
The good news is that there is always a suitable option fitting each sponsor’s available budget.
Not Just the EDC: The Need for Clinical Data Management Services
Another point to be taken into account is the cost of the clinical data management services related to the EDC software. In other words, you can pay the fees of an EDC system but, who is going to write and review the specifications of the system? Who will turn these specifications into the actual data forms and fields? There is actually significant documentation and specialized work related to the definition, implementation, and testing of an EDC tool. And once the tool is up and running, you will need more support for data cleaning and analysis. It is not just the EDC software cost.
There are companies specialized in helping trial sponsors with all the tasks related to EDC build and clinical data management. These companies are normally clinical research organizations (CROs) with biometrics departments providing clinical data managers and statistical programmers. Therefore, these costs should be considered in addition to the actual cost of the EDC application itself.
EDC Pricing Models
Each EDC system vendor has its own pricing model. Some will charge based on the number of EDC pages to be used, and others will calculate the price considering the number of users and/or clinical sites.
Nevertheless, many EDC software suppliers are offering their products with a fixed monthly fee depending on the type, size and duration of the study. Thus, the sponsor must pay a monthly fee for the duration of the clinical trial.
Some EDC Cost Estimates
So let’s come back to our main big question: how much does an EDC system cost? Depending on the level of sophistication, integration potential, and technical functionalities, we could differentiate between three price ranges:
- High-end EDCs: US$ 5,000 per month
- Mid-priced EDCs: US$ 3,000 per month
- Low-cost EDCs: US$ 1,000 per month
Based on these pricing assumptions we can think of the overall cost of an EDC solution to be used in a phase 1 clinical trial in oncology with 5 clinical sites, 20 patients, and a duration of 9 months of recruitment plus 6 months of survival follow up.
Since the entire duration of the study would be 15 months, the EDC usage fees would be between US$ 75,000 and US$ 15,000, depending on the selected software.
In summary, the cost of an EDC system for a clinical trial can be in the range of US$ 5,000-1,000 per month. This is only the price of the software itself, not including the related data management tasks that will also be needed to put the EDC tool into action, and then collect, clean, and analyze the data.