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Timaeus Electronic Data Capture

Timaeus Electronic Data Capture (“EDC”) enables clinicians and trial investigators to capture study data in a secure, validated database. Timaeus EDC is designed for use by investigators, study coordinators, and read-only roles.  Timaeus EDC can be used for paper data collection, electronic data collection, or a hybrid combination. 

Optimised for local use

Cmed has focused on providing a highly positive EDC experience for site staff through a combination of simple navigation aids and intuitive data entry with dynamic screens and forms. In addition, it uses Timaeus’ cloud computing architecture to avoid “classic EDC pain points” by allowing mid-trial updates without interruption and ensuring fast, 24/7 access to all required data regardless of location.

Oriented for clinical staff

Timaeus EDC is designed for use by investigators, study nurses, and study coordinators. This simplifies training requirements and 21 CFR Part 11 compliance.

Fully integrated with data management operations

Timaeus EDC enables investigatory staff to work with the same data used by monitors, medical coders and data managers. This eliminates reconciliation steps and streamlines medical coding, application of validation checks, and resolution of queries. Timaeus EDC also adds hierarchical- and filter-based navigation to performing these activities faster and more straightforward.

Extended eSource capability

Timaeus EDC can also be implemented to support an eSource model. This provides sponsors and other interested parties real-time insight into the clinical data and the progress of the trial.

Major features and functionality

  • Subject enrolment
  • Blinding enforcement
  • Data entry with real-time data validation
  • Dynamic pages and forms
  • Clinical annotations
  • Enforcement of completion guidelines
  • Data review, cross-out and correction
  • Enforced audit trail and inspection of data changes
  • Real-time Error resolution
  • Real-time Query response management
  • Serious adverse event (SAE) capture and reporting
  • Investigator sign-off
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