.jpg)
In the realm of clinical trials, electronic data capture (EDC) has become indispensable. This technological choice is far from trivial and can have a significant impact on the success of your study. What are the essential criteria to consider when selecting the EDC solution best suited to your needs?
Checklist of Criteria to Evaluate
Essential Features
The first step is to identify the modules and functionalities necessary for your specific study. Each clinical trial has its unique aspects that require a customized approach. Your EDC solution must allow for structured and secure collection, storage, and management of clinical data.
The ability to upload patient files and images is also crucial. Carefully review the file size limits provided by the solution since some assessments may produce large documents.
Randomization is another key element to consider. Should your EDC system include a built-in randomization module, or would it simply allow importing a pre-established list?
Accessibility and Usability
The intuitiveness of the user interface directly contributes to investigator site and user adoption. A complex system can lead to frustration, errors, and delays. Choose a solution with a minimal learning curve and rapid adoption.
A multi-language capability is also essential for international studies. Your EDC must adapt to both the language of the users and, importantly, the patients participating in the study.
Regulatory Compliance and Security
Compliance with international standards is non-negotiable. Your EDC solution must meet current regulations, such as:
• GDPR in Europe
• ICH GCP E6 for good clinical practices
• HIPAA in the United States
• FDA 21 CFR Part 11 for electronic signatures
Data hosting should also meet high standards, such as HDS (Health Data Hosting) certification or ISO 27001 standards. Some countries may have specific requirements that must be taken into account.
Flexibility and Customization
Flexibility is a decisive criterion. Your EDC solution must adapt to the specifics of each study, whether it be in terms of data collection, workflow, or reporting. A “one size fits all” approach is rarely optimal in clinical research.
A no-code solution can offer a significant advantage by allowing clinical teams to configure their study without always relying on technical support.
Real-Time Monitoring
Dynamic dashboards and reports are essential for efficiently overseeing the progress of your study. They allow for the quick identification of issues, monitor patient recruitment, and improve the quality of the data collected.
Advanced Technologies
Consider the specific needs of your protocol:
• Real-World Data: Capturing off-site data via patient questionnaires is becoming indispensable for certain studies.
• Patient Access: The BYOD (Bring Your Own Device) approach enables patients to use their own devices, although dedicated devices might be necessary in some contexts.
• Connectivity: APIs facilitate integration with other tools and connected medical devices, creating a cohesive data ecosystem.
• Web Technologies: Favor web-based solutions that do not require complex installations.
• Remote Capabilities: Tele-visit features become essential for decentralized or hybrid studies, ensuring remote patient monitoring.
.png)
