How much does an Electronic Data Capture (EDC) platform cost?
This is a question that sponsors of clinical trials or observational studies frequently have when presented with the need to collect patient data in their commercial or academic studies.
There is no doubt that it is necessary to include the cost of specifying, implementing, testing and validating an EDC system in the general budget of a clinical study since, after all, the data collection tool is a fundamental element in this type of research project.
In this article, we will explain the main costs associated with an EDC platform, both in the initial definition and implementation phase and during the development of the subsequent stages of the study.
The price of an EDC system: user license and hosting
Essentially, the main cost of an EDC software is related to its user license and hosting (hosting on a server).
Although each EDC system provider offers its own billing scheme, it is common for the contracting modality to consist of a fixed monthly fee, which depends on the size of the study, that is, the number of participating hospitals, users and patients.
A fixed monthly billing scheme is convenient as this allows the clinical trial sponsor to calculate and control the cost of the EDC system over the duration of the study, while remaining within the budget.
A variety of EDC options are currently available, with many manufacturers of this type of system worldwide making a wide range of solutions available.
It is also important to understand that there are different types of EDC systems —with more or less advanced features— that best fit the available budget.
On the one hand, there are EDC systems that could be considered high-end, offered by multinational manufacturers with a high level of sophistication. These software products have very powerful and advanced features and are typically adopted by sponsors running large commercial clinical trials.
On the other hand, there are cheaper EDC systems with less powerful functions, but still perfectly suitable for studies with smaller budgets. These systems are desirable in the context of non-profit academic clinical research, when the sponsor has limited funding.
Focusing on the key question under consideration, the cost of licensing and hosting an EDC software ranges from US$600 to 4,000 per month, so if a study lasted 24 months, the cost of this would be between $14,400 and 96,000 in total, depending on the type of system chosen.
Nevertheless, the use of an Electronic Data Capture system involves additional costs associated with (1) the initial specification of the system, (2) building and initial testing and (3) data cleaning.
These additional services are usually provided by companies specialized in clinical data management, known as clinical research organizations (CROs).
The prices for these services may vary depending on the number of EDC forms as well as the number of participating hospitals and patients.
In our case, we will assume the participation of 5 centers and 50 patients in a 24-month study.
Initial Specification of the EDC System
The process of implementing an Electronic Data Capture system begins with the specification of the system, which involves the generation of a number of documents.
The documents required to build an EDC system include the Data Management Plan (DMP), the annotated CRF, and the Data Validation Plan (DVP).
The DMP includes the various aspects of the data management process throughout the clinical trial, from initial data collection to data cleaning, analysis, and final long-term storage, including security mechanisms.
The annotated CRF (which stands for ‘case report form’) is a document that specifies the forms, fields and variables that constitute the EDC platform, and serves as a formal specification for carrying out the building of the system.
Finally, the DVP specifies the conditions that must be met for the study data to be considered valid and suitable for analysis. Data managers use the DVP to review and clean clinical data until it is clean, accurate, consistent and free of discrepancies.
The approximate cost of producing the abovementioned documents is around $8,000 in total.
Building and Testing of the EDC Platform
Once the necessary specification documents are prepared, everything is ready to start building the system.
Based on the detailed specifications, the data managers of the CRO proceed to build the EDC software, which consists of the assembly and configuration of the forms and fields where the data are inserted.
In this step, not only the forms and fields of the EDC platform are created, but also the automatic inconsistency detection mechanisms (e.g. the system can automatically detect if the value of an analytic is within certain expected ranges).
Additionally, the process of building the EDC software is followed by tests (testing) executed to verify that the forms and fields work well, meeting the client’s requirements.
The service of building and testing an EDC system can cost around $10,000.
EDC System Data Cleaning
Having built and tested the EDC software, the system is now ready to be used by hospital users.
After receiving initial training, site-based research teams start entering data into the EDC platform as they recruit patients in the clinical trial.
Nonetheless, entering data into the EDC system entails work to reclaim and rectify information, since it is common for hospital users to leave fields empty or enter erroneous data.
The data review and cleaning work is carried out by the CRO’s data managers, who are responsible for detecting missing information and inconsistent data. These managers send queries to the centers for resolution.
Assuming a 24-month trial, with 50 patients recruited by 5 hospitals, the cost of data cleaning would be around $25,000.
The following is a summary of the costs described in this article:
- License and hosting of the EDC system: Range between $14,400 and 96,000 (depending on the type of software chosen).
- Initial specification: $8,000
- Building and testing: $10,000
- Data cleaning: $25,000
If we consider a mid-range EDC software, assuming a total licensing and hosting cost of $40,000, the total cost of the project described in this article would be $83,000 .
When calculating the cost of an EDC system, the associated data management services that are essential must also be taken into account.
In addition to the licensing and hosting of the EDC software, the costs of initial specification, building and testing, and cleaning must also be considered.
It is also important for clinical trial sponsors to be aware that Electronic Data Capture systems are available at different prices, so they should take the time to consider which solution best suits their technical needs and budget.