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TrialMaster
Details

TrialMaster is a leading-edge system for Electronic Data Capture and Clinical Data Management. It allows authorized users to enter and manage clinical trial data according to the defined protocol. This data sheet provides a summary of the available features, illustrated by screenshots and examples.

Overview

TrialMaster includes the following functionality:

Setup and Administration

        • Set up of roles, users and sites
        • Assignment of users to sites
        • Creation of patients
        • Entry of lab reference ranges

Interfaces and Integrations

  • Import of external data
  • Generation of safety cases in E2B format
  • Coding of medical terms against MedDRA and WHO Drug
  • Read and write access to study data via web service APIs

Data Entry and Management

  • Entry of patient data
  • Real-time execution of edit checks and derivations
  • Management of system-generated and manual queries
  • Checking of lab data against reference ranges
  • Generation of internal and email notifications on events such as SAEs
  • Monitoring, locking & electronic signature of  iCRFs

Reporting and Exports

  • Execution of standard reports
  • Development and execution of adhoc reports
  • Generation of data exports, in SAS or CSV format
  • Generation of SDTM exports
  • Production of site archives, including FDA submission format

 

TrialMaster offers so much more than a typical electronic data collection (EDC) solution. Its functionality includes many of the features in other clinical trial applications, such as  a Clinical Trial Management Systems (CTMS), to allow study personnel to better manage and support clinical trial initiatives; a safety solution, to better manage SAE tracking and reporting for regulatory purposes; a coding solution, to allow for coding of verbatim terminology utilizing MedDRA and WHO Drug; a randomization solution, for patient enrollment; and an open application programming interface (API) to share information across disparate systems.

This breadth of functionality and the ability to perform tasks typically seen in multiple clinical applications is unrivaled by any other EDC solution in the industry, and offers unique business benefits to our customers- improved efficiency, better communication across multiple business units, faster study completion, and a reduction in costly integration projects- all translating into significant cost savings across your organization.

Our ability to compete within the EDC industry is predicated on our ability to continue enhancing the scope of solutions offered through TrialMaster.  OmniComm’s goal is to continue to develop and implement additional functionality to meet the evolving needs of our customer base, and to form partnerships with leading clinical solutions providers to supplement our product offering.

Features & Functionality at a Glance

Microsoft .NET Standard Middleware

  • Microsoft .NET architecture
  • Ease of integration
  • Superior data import/export functions
  • Support for web service calls
  • Simple to implement Mid study changes
  • Encoded SSL Connection

Benchmark for Study Build Time

  • Logical drag and drop trial building
  • Library of re-usable forms
  • Programmerless edit check design
  • Interface with e-Protocol systems

Designed to be ‘Site-Friendly’

  • Extremely intuitive
  • Requires minimal training
  • Role based access to relevant information
  • Task driven workflow
  • Simplified tree-like navigation

Maximum Design Flexibility

  • User-friendly GUI
  • Add custom specific modules
  • Multiple patient/subject types
  • All screens considered “CRFs”
  • Customization Style Sheets
  • Javascript Forms Customization
  • Auto/Manual Form Rendering

Performance

  • No plug-ins (browser-based)
  • Speed & reliability
  • 128-bit SSL encryption
 

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2101 West Commercial Blvd. Suite 3500 Ft. Lauderdale, FL 33309 • 877-GO-TO-EDC | 877-468-6332