The eClinical Suite

A Fully Integrated eClinical Solution


A robust solution with EDC, CTMS, CDMS, adverse event reporting, modules for Phase I - IV clinical trial research.

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Whether you are a pharmaceutical, device, biotechnology, academic or government institution, the OmniComm eClinical solution is a proven system for large scale global projects or single site Phase I studies.

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Product Overview

The eClinical suite provides a comprehensive, functionally-rich solution to streamline clinical trial processes and supports DDE and EDC within one system. It uses proven workflows that enable clinical operations to effectively plan each stage of a trial. The eClinical suite is able to capture, manage, clean, export and lock trials quickly and cost-effectively. Whether you are a pharmaceutical, device, biotechnology, academic or government institution, the OmniComm eClinical solution is a proven system for large scale global projects or single site Phase I studies.

Whether you are a pharmaceutical, device, biotechnology, academic or government institution, the OmniComm eClinical solution is a proven system for large scale global projects or single site Phase I studies.











eClinical Suite Modules

eClinical Portal

The gateway to the eClinical Suite, the portal is a multi-level dashboard for study metrics, reports and a repository for study files. The portal provides users with access to key metrics and study data, enabling a comprehensive view for ongoing decision making. With a "zero footprint" this web application controls access to the eClinical Suite and clinical data.

Access Control Features

  • User account management
  • Study map showing study and site access and provides study navigation options
  • Displays for configurable trial and clinical metrics
  • Access Security - password complexity, inactivity timeout, etc.
  • The ability to manage forgotten password access
  • Folders to store and distribute electronic files
  • The ability to host and moderate discussion boards
  • User profiles to control content and functionality
  • Personal portal experiences - content and portlet positioning
  • A "My Favorites" section which provides hot links to other URLs

    • EDC Management Features

  • EDC data capture and review
  • Status Management
  • Autoencoder
  • Site Summary Report
  • Ad hoc reporting tool
  • SAS and ASCII extracts

    • eData Capture

    A zero footprint, full-service Electronic Data Capture (EDC) system. Monitoring, and data management tools are included. A configurable workflow provides adherence to customer procedures for monitoring and data management.

    eData Management

    A CDMS system that includes a robust standards-based design tool for eCRF and edit checks, meeting your needs for Double Data Entry (DDE) and paper based studies. Study and cross-study analysis are enabled in a single data repository.

    Ad-Hoc Reporting

    A user-friendly tool for creating real-time reports and data listings in Excel and ASCII, as well as providing CDISC ODM exports, and on-demand SAS extracts.

    AutoEncoder

    A configurable tool for coding of clinical data, e.g. adverse events, medical history, concomitant medications, etc. against commercial and/or user defined dictionaries e.g. MedDRA / WHO Drug, etc.

    eStudy Conduct

    A Clinical Trial Management System (CTMS) for project planning and management, study management, monitoring, and accounting.

    Adverse Event Reporting

    A system for data entry and management related to adverse events and serious adverse events. Serious Adverse Events can be reported using the standard reports and exports for CIOMS, FDA and EMEA.

    eHealth Education

    A self-paced training tool for sites, monitors, data managers and other clinical trial staff. Includes practice simulations and certification processes.