FACT SHEET
Deliver a dynamic and intuitive patient and user experience to support patient trial understanding and compliance and clinician trust.
eConsent
Improve Patient Enrollment
eConsent drives engagement by educating patients and caretakers about clinical trial information, as well as guiding them through the enrollment process.
Part of the Clinical ink eSource technology, eConsent helps raise patient comprehension, simplify workloads for sites and study teams, and improve data quality to support decision making and regulatory compliance.
eConsent Benefits
Optimize
Patient Experience
Easy-to-follow, patient-friendly eConsent forms deliver tiered information, knowledge checks.
Available with reconsenting triggers, graphical and video content, and translation to 40+ native languages.
Improve
Consent Process
Ensure eConsent compliancy using real-time triggers, notifications, progress metrics, and reporting.
Educate and guide patients, minimize errors, and achieve better data quality.
Reduce
Site Workload
Manage end-to-end eConsent and re-consent processes easily. Monitor patient interactions and ensure they are always kept up to date on protocol changes.
Save
Time and Money
Accelerate your study startup from months to weeks with drag-and-drop authoring tools and rapid prototyping. Minimize strain on your study teams and sites while reducing costs.
Eliminate
Separate Systems
Integrate across Clinical ink eSource technology – DDC, ePRO, eCOA – to simplify end-to-end data capture processes.
Evaluate
Patient Snapshots
Access and monitor real-time status of a clinical trial patient quickly and easily.
Improve
Workflows
Enhance eConsent with dynamic visit creation and conditional logic across clinical trials workflows.
Ensure
Compliance
Ensure clinicians are CFR Part 11 compliant with signature requirements integration.
Frequently Asked Questions
What is eConsent?
eConsent is the digital process of obtaining informed consent from participants in clinical research. It involves providing comprehensive, user-friendly information about the trial electronically, often through videos, images, or interactive content. Participants review the information and provide their consent by signing digitally. This process enhances understanding, accessibility, and traceability, aligning with regulatory compliance.
What are the advantages of eConsent over traditional paper-based consent?
eConsent offers several benefits over paper-based methods:
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- Enhanced Understanding: Multimedia and interactive content can improve participant comprehension.
- Accessibility: Participants can access and review information at their convenience.
- Traceability: Digital signatures and timestamps offer secure and verifiable consent tracking.
- Environmental Sustainability: Reduces the need for paper.
- Regulatory Compliance: Meets legal requirements and facilitates easier auditing.
Is eConsent secure and compliant with regulatory requirements?
Yes, eConsent clinical trials adhere to stringent regulations, including FDA 21 CFR Part 11 and HIPAA. Our platform incorporates cutting-edge security measures, ensuring the protection of personal information and the integrity of the consent process.
How does eConsent enhance participant engagement in clinical trials?
Clinical ink eConsent fosters engagement by providing information in an easily digestible format, using multimedia tools. Participants can review materials at their own pace, ask questions, and feel more informed and empowered in their decision-making process. This patient-centered approach improves trust and overall satisfaction.
Can eConsent be integrated into existing clinical trial workflows?
The Clinical ink eConsent solution is designed for seamless integration into existing clinical trial workflows. Our platform offers flexibility and customization to align with your specific study requirements. By working closely with your team, Clinical ink ensures a smooth transition to the digital consent process, providing training and support as needed.
