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eCONSENT

Digital, compliant consent experience for clinical trials, enhancing participant comprehension and regulatory compliance with multilingual and interactive features.

Solution by Quantum Quip
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Overview

The eConsent platform transforms traditional paper-based consent processes into a digital format that is compliant, patient-friendly, and designed for clinical trials, research studies, and medical device evaluations. The system ensures that participants fully understand the study details before they give consent, while allowing sponsors and CROs to maintain audit-ready documentation in real time.

Key features include multilingual capabilities, interactive content to improve understanding, and secure authentication methods. These elements help in enhancing participant comprehension, accelerating enrollment, and ensuring regulatory compliance.

Product Features

  • Interactive Consent Forms: Include videos, diagrams, and FAQs to enhance participant comprehension.
  • Multi-Language Support: Consent forms available in multiple languages to accommodate diverse patient demographics.
  • Electronic Signature Capture: Collect legally compliant e-signatures through secure authentication.
  • Version Control & Audit Trails: Track every change and interaction for compliance with 21 CFR Part 11.
  • Real-Time Status Tracking: Instantly monitor who has viewed or signed the forms and who needs a follow-up.
  • Remote Consent Capability: Obtain participant consent remotely, reducing the need for site visits.
  • Integration with EDC & CTMS: Automatically sync consent records with electronic data capture (EDC) and clinical trial management systems (CTMS).

Overall, the eConsent solution simplifies, secures, and speeds up the consent process, fostering faster, safer, and more patient-oriented consenting in clinical settings. Users can schedule a demo or download a brochure for more in-depth information.

Meta

Category
Clinical Trial Management
Field(s)
Clinical & TrialsQuality & Compliance
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic Professional
Tag(s)
Clinical Trials ManagementQuality & Compliance Management