An Affordable EDC System for Clinical Trials
In the world of clinical trials, the adoption of Electronic Data Capture (EDC) systems has revolutionized the way data is collected, managed, and exported.
These web-based applications have replaced traditional paper-based Case Report Forms (CRFs), significantly improving the efficiency of data management.
However, one of the major challenges faced by some clinical trial sponsors is the cost associated with implementing an EDC system.
In this article, we will explore the importance of affordable EDC systems in clinical trials and introduce Klindat, a low-cost EDC platform that provides a solution for researchers on a limited budget.
The Cost of EDC Systems
Implementing an EDC system can be a costly endeavor, especially for academic sponsors or non-profit research groups with limited funding.
The initial start-up cost of an EDC platform typically ranges between US$ 6,000 and US$ 12,000, followed by a monthly subscription and hosting fee of US$ 1,500 to US$ 5,000.
For example, an average 36-month phase 2 clinical trial in oncology would require an EDC software with an overall cost of approximately US$ 108,000 in monthly fees alone.
While these prices may be affordable for commercial sponsors, they pose a significant challenge for academic sponsors who have fewer financial resources available.
The Need for Affordable EDC Platforms
Given the budgetary constraints of academic clinical research and publicly funded trials, there is a growing need for affordable EDC tools that can maintain high-quality standards.
Independent investigators, non-profit research groups, and publicly funded trials often operate with lower budgets compared to industry-sponsored commercial trials.
To ensure that these studies can be conducted without compromising on data management and quality, affordable EDC systems are essential.
Introducing Klindat: The Low-Cost EDC System
Zlynger, a leading software company, has developed Klindat, a low-cost EDC system specifically tailored for clinical studies with limited budgets.
Despite its affordability, Klindat complies with all regulatory and quality standards required by the industry.
Let’s explore the main features of this cost-effective solution:
Simplicity and Accessibility
Klindat stands out for its simplicity, making it intuitive and easy to use for researchers.
It is a web-based application that does not require any installations, allowing users to access it through the internet from multiple devices and browsers.
Security and Reliability
Ensuring data security and reliability is fundamental in clinical trials.
Klindat incorporates access control mechanisms, SSL encryption, and daily backups to ensure the confidentiality and integrity of the collected data.
The system meets HIPAA, GCP, and 21 CFR Part 11 requirements, providing study sponsors with peace of mind.
Powerful Data Management and Customizable Reporting
Klindat offers robust features that simplify data management tasks and provide customizable reporting tools.
The platform is adaptable to studies of any size, offering great customization potential and complete design flexibility for optimized workflows.
Cloud Storage for Documents and Files
For studies that require document storage and large file uploads, Klindat offers cloud storage capabilities.
Researchers can upload documents such as Word or PDF files and even medical images in DICOM format, including imaging viewers.
The Cost of Klindat EDC System
Now, let’s delve into the cost structure of Klindat, which is straightforward and transparent, eliminating any unexpected surprises for clinical trial sponsors.
The Klindat EDC application consists of two cost elements:
The initial cost of Klindat includes defining the specifications and building the forms required for the study.
This start-up cost ranges between US$ 3,000 and US$ 8,000, depending on the number of forms.
Monthly Usage and Hosting Subscription
In addition to the initial cost, there is a monthly usage and hosting subscription fee.
This fee varies based on the number of patients included in the study and ranges from US$ 300 to US$ 700 per month, which is a very competitive price.
Affordability is a decisive factor when it comes to selecting an EDC system for clinical trials.
Klindat, with its low-cost solution, offers a compelling quality-price ratio, without hidden charges, making it an ideal choice for researchers who have limited budgets.
Its simplicity, security, powerful features, and customization options make it a valuable tool for conducting high-quality clinical studies.
By providing affordable EDC systems like Klindat, we can ensure that all investigators and sponsors, regardless of their funding constraints, have access to the necessary tools for successful clinical trials.
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