Timaeus Electronic Data Capture
Timaeus Electronic Data Capture (EDC) enables clinicians and trial investigators to capture trial data on-site. Investigatory staff can access Timaeus EDC using a variety of different user interfaces. Data entry is optimised for local fast access and ease of use.
Optimised for local use
Timaeus EDC allows entry of data through a selection of user interfaces: browser, laptop appliance and mobile tablet appliance. It provides fast access to required data functionality regardless of location. It also allows users to identify themselves via biometric fingerprint identification in addition to normal user ID and password combinations.
Oriented for clinical staff
Timaeus EDC is designed for use by investigators, study nurses, and read-only roles (e.g., sponsor staff). 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.
Major features and functionality
- Schedule management
- Subject enrolment
- Schedule selection
- Blinding enforcement
- Data entry
- Studybook navigation
- Clinical annotations
- Enforcement of completion guidelines
- Data review, cross-out and correction
- Enforced audit trail and inspection of data changes
- Real-time and batch error resolution
- Real-time query management
- Serious adverse event (SAE) alerting and reporting
- Studybook signing
- Real-time metrics
- Real-time drill-down reporting
