Timaeus Electronic Data Management
Timaeus Electronic Data Management (“EDM”) allows clinical data management staff to work in a variety of roles to manage the entire workflow from receipt of captured data to final locking of the trial. This works equally well with small or large trials. Data management workflows can be executed centrally or across global teams.
Support for a wide range of roles
Timaeus EDM provides functionality for the complete range of data management roles: system administration, trial administration, coding, entry, export, monitoring, statistical analysis, validation and verification. Functions are designated by role, facilitating conformance with existing standard operating procedures (“SOPs”).
Ability to manage all data from a unified view point
Timaeus EDM enables integration and management of all data (both CRF and non-CRF) from one system. This eliminates reconciliation needs, streamlining activities such as validation checking, medical coding and query resolution.
Timaeus achieves this using a distributed architecture, enabling data management to be performed from many locations (and for large studies) with high reliability and fast performance.
Real-time status reporting
Timaeus has built-in status reporting tools, including a continuously updated summary of status at each level of the trial hierarchy (i.e., programme, study, CRO, country, site, patient). These reports run in real time, against fully up-to-date clinical data.
Major features and functionality
- Trial administration (site setup, trial modification, etc.)
- Blinding management
- Subject enrolment
- Branch resolution
- Entry of paper-based CRFs
- Import of local and central laboratory data
- Data review, cross-out and correction
- Enforced audit trail and inspection of data changes
- Real-time query management
- Serious adverse event (SAE) alerting and reporting
- Data locking and lock administration
- Data management metrics
- Built-in data management reporting
- SAS Dataset export (on-demand)
