You can visit klindat.com to learn more about Klindat EDC software
Electronic Data Capture (EDC) systems are web applications used to collect, clean, and export data in clinical trials and post-marketing studies.
These electronic platforms have been replacing the old paper-based CRFs, which has drastically increased the efficiency of data management in clinical trials.
In this article you will learn about:
In some cases, one of the barriers that clinical trial sponsors may encounter is the cost of the study, and more specifically the price of the EDC system.
How Much Does an EDC System Cost?
To get an idea, an EDC platform can have an initial start-up cost of between US$ 4,000 and US$ 12,000, followed by a monthly subscription and hosting fee of between US$ 1,500 and US$ 5,000.
This means that a phase 1 clinical trial in oncology, for example, lasting 18 months, would require EDC software with an overall cost of around US$ 66,000 (assuming US$ 12,000 for initial build and a monthly fee of US$ 3,000).
These prices may seem affordable for commercial sponsors but can be a major challenge for academic sponsors with less funding available.
The Need for an Affordable EDC Platform
Given this reality, there is a need for affordable EDC tools adapted to the budgetary constraints of academic clinical research.
Some examples of these types of academic studies are clinical trials sponsored by independent investigators or non-profit research groups.
It is also important to consider publicly funded clinical trials, that is, money provided by regional or national government funding programs.
In general, these public aid programs contribute amounts lower than those that are handled in industry-sponsored commercial clinical trials, in which investors are involved.
Therefore, the need for a low-cost EDC system is fairly common, and it is necessary to provide adequate solutions that allow low-budget, non-profit studies to be conducted with high quality standards.
Klindat: The Low-Cost EDC System
The company Zlynger has developed the Klindat EDC system, which is offered in a version especially targeted at clinical studies with a limited budget.
Despite not being an expensive software, the Klindat EDC platform complies with all regulatory and quality standards required by the industry.
The main features of this tool are summarized below:
- The application stands out for its simplicity, which makes it intuitive and very easy to use, being accessible through the Internet (no installations required) and compatible with multiple devices and browsers.
- Klindat is highly secure and reliable including access control mechanisms, SSL encryption and daily backups. The system ensures high service availability and meets HIPAA, GCP and 21 CFR Part 11 requirements.
- The platform has powerful features that facilitate data management tasks and customizable reporting tools. It is adaptable to studies of any size and offers great customization potential as well as complete design flexibility for optimized workflows.
- If required, cloud storage can be made available for uploading documents (Word, PDF, etc.) and large amounts of files (medical images in DICOM format), including imaging viewers.
How Much Does the Klindat EDC System Cost?
That brings us to the part we have all been waiting for: How much does the Klindat software cost?
The Klindat EDC application has two cost elements. Firstly, there is an initial cost for defining the specifications and building the forms. This start-up cost is around US$ 3,000-8,000, depending on the number of forms required.
Secondly, there is a cost for the monthly usage and hosting subscription, which ranges between US$ 300 and 700 per month, depending on the number of patients included in the study.
As can be seen, this is a very simple and transparent contracting model. In this way, clinical trial sponsors that choose Klindat avoid unexpected surprises.
Conclusion
Sofpromed CRO recommends the use of Klindat. This EDC software has a very interesting quality-price ratio, being a powerful solution at a technological level and certainly affordable for all budgets.
You can visit klindat.com to learn more about Klindat EDC software
