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eDiary

Electronic Clinical Outcome Assessment for patient diary collection across web, tablet, and mobile devices with FDA 21 CFR Part 11 compliance.

Solution by Dacima Software
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Overview

eDiary is an electronic Clinical Outcome Assessment (eCOA) software developed by Dacima Software. It supports building online diaries that study participants complete using a PC, tablet, or smartphone, enabling direct data collection from patients at the point of experience. The tool is designed for medical and health-related research studies and complies with FDA 21 CFR Part 11 and Good Clinical Practices (GCP), including a complete audit trail.

eDiary is aimed at clinical research teams that need to improve patient engagement and maintain data quality throughout diary-based data collection workflows.

Core Features

  • Designed for smartphone use to support easy daily completion by participants.
  • Integrated with the Visit Scheduler module to coordinate diary tasks with study visits.
  • Sends scheduled links to participants for diary completion at defined timepoints.
  • Supports sending multiple reminders via email or SMS.
  • Notifies sites when a diary has expired.
  • Customizable invitation emails and SMS messages.
  • Welcome and completion pages can be tailored to study requirements.

Data Management and Reporting

  • Tracks patient diary completion through custom reports and dashboards.
  • Supports conditional dependencies to enable or disable fields, show or hide fields, trigger popup messages, and change field colors based on responses.
  • Offers multiple data extraction options to suit different output needs.
  • Includes a Query Builder for extracting data subsets and generating aggregate or summary statistics reports.
  • Built-in reports provide summary statistics, data dictionaries, data query reports, and additional outputs.

Diary Manager

  • Provides access to diary management tools for tracking respondent completion status.
  • Manages invitations, reminders, welcome pages, and other participant-facing content.
  • Includes reporting, data extraction options, and the Query Builder for creating custom reports and outputs.

Dacima Software is part of the EvidentIQ Group. A trial version of the software, including a 30-minute guide, is available on request, and personalized demos can be booked for study-specific feedback.

Meta

Domain
Clinical Trial Management
Subdomain
Patient-Reported Outcomes (ePRO/eCOA) & Patient Engagement
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROPharma
Development stage(s)
ClinicalPost-Market & RWE
Target user(s)
Research ScientistClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxP