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eCOA

Digital data entry for clinical outcomes assessment without transcription from paper forms or charts.

Solution by Dacima Software
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Overview

Dacima's Electronic Clinical Outcomes Assessment (eCOA) is a web-based software solution that enables clinicians to enter clinical outcomes data digitally, removing the need to transcribe data from paper forms and charts. It is designed for use in clinical studies and can function as a stand-alone tool, independent of any specific eClinical technologies such as EDC systems, or it can be integrated into an existing eClinical software environment.

The platform is built to collect reported outcome data in a compliant and efficient manner, guiding proper protocol execution while automatically validating data at the point of entry. It is intended to be accessible to users with varying levels of research experience.

Form Design and Configuration

  • Supports design and configuration of eCOA forms to meet specific study protocol requirements through a drag-and-drop designer for rapid setup and implementation.
  • Forms can be designed to mimic familiar paper-based documents or configured with advanced options including touchable image icons, edit checks, and skip logic for interactive and intuitive data entry.
  • The web-based interface allows clinicians to enter data via computer, tablet, or smartphone through a browser, with no app installation required.
  • The software automatically detects the device type and adjusts the display to suit the screen size.

Data Quality and Compliance

  • Prevents inconsistent or conflicting data entries.
  • Eliminates transcription errors associated with paper-based data collection.
  • Meets global regulatory standards.
  • Automatically validates data upon entry to support data quality and protocol adherence.

Deployment and Integration

  • Can be used as a stand-alone solution without dependency on other eClinical technologies.
  • Supports integration into existing eClinical software landscapes.
  • Delivered as a web-based platform accessible through standard browsers on multiple device types.

Dacima Software is part of the EvidentIQ Group, alongside Carenity and Fortress Medical Systems. A trial version of the software, including a guided walkthrough, is available upon request, and personalized demos can be arranged to address specific study requirements.

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 ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11