eConsent logo

eConsent

Remote and in-person digital informed consent with integrated EDC/eSource for clinical trials.

Solution by Dacima Software
Visit website

Overview

Dacima's eConsent is an electronic informed consent solution integrated within Dacima's EDC/eSource platform, designed for clinical research teams and study sites. It supports both in-person digital consenting and remote consenting, allowing participants to complete the consent process from home, a doctor's office, or any other convenient location.

The solution is built to simplify the consent workflow, improve patient comprehension and retention, and reduce administrative workload for study teams and sites. The electronic informed consent form (eICF) can incorporate videos, graphics, and PDF files to support participant understanding, and the system is designed to meet regulatory compliance requirements.

Key Features

  • Integration with Dacima's EDC/eSource solutions, eliminating the need for separate systems.
  • In-person eICF delivery via shared tablet or push to kiosks and tablets in waiting rooms.
  • Remote consenting via eICF links sent by email or SMS.
  • Self-recruitment capability, allowing patients to complete the eICF after registering and creating an account through a lobby page.
  • Real-time subject status tracking to support patient recruitment and data collection.
  • Flexible eICF design including embedded video, graphics, PDF files, and consent acknowledgement checks.
  • Support for multistep inclusion processes, covering screening, consenting, eligibility checks, and randomization.
  • Ability to create multiple consents within the same study.
  • Configurable workflows with dynamic visit creation, form activations, and conditional logic.
  • eICF signing triggers to ensure required signatures comply with regulatory requirements.
  • Detailed audit reports capturing all activities, including form opening, signatures, and modifications.

Deployment and Access

  • Available as a fully functional trial version, accompanied by a 30-minute guide.
  • Supports personalized demos with feedback on specific study requirements.
  • Available in English and French.

Dacima Software is part of the EvidentIQ Group, alongside Carenity and Fortress Medical Systems. The eConsent solution is positioned as a fully compliant tool suitable for regulated clinical trial environments.

Meta

Domain
Clinical Trial Management
Subdomain
eConsent & Remote Visits
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROPharma
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxP