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Timaeus today

The emphasis is on today. Not tomorrow, not next month or next year, or the next release with constantly slipping dates.

Timaeus is ready to implement today. It's a fully validated and documented, 21 CFR part 11 compliant system and has successfully undergone several independent audits by large, global pharmaceutical companies.

Timaeus is so much more than an electronic Data Capture system (eDC). Hence Cmed coined the term intelligent Data Acquisition and Management (iDAM) to better represent the system's design and its capabilities.

Timaeus today includes the following benefits:

Best in class technology

Unlike other eDC and clinical data management systems, Timaeus is not based upon 1970s relational database technology which is no longer appropriate. Rather, we offer the unparalleled flexibility of a custom, post-relational, peer-to-peer design, seamlessly coupled with the reporting ease of a SQL-based reporting database.

That means:

  • No messy integration work between eDC and eDM databases.
  • No lag as data moves in batches between eDC and eDM databases
  • A single database configuration step that includes data capture, data management and all your operation and reporting needs.

Fast database configuration

We've worked hard to make our database configuration environment clean, concise and powerful. Timaeus delivers:

  • Rapid database build and deployment counted in days not weeks
  • The ability to release revisions to live trials without end users having to do so much as log out of their session.
  • A CDISC SDTM ready environment.
  • Tools to develop screens / eCRFs based on the W3C standard XML language structure.
  • Standard library management with version control and full audit trail separate from release cycle.
  • A simple yet powerful validation check configuration language — program and fire checks of any complexity, derived across multiple visits.
  • Automated testing tools for all system interfaces.

Multiple data capture options

Timaeus is a single core with multiple views. This unique flexibility means that Timaeus is shaped to meet the needs of each clinical trial, rather than trials being shaped to allow eDC.

  • Full paper CRF processing and management including:
    • Workflow and status management.
    • Paper trail management
  • Web enabled data capture:
    • Optimised for speed and simplicity.
    • Sites can access the interface from their own hardware, if available.
    • Operates with low bandwidth comms with no loss of functionality.
    • Web 2.0 design principles, including AJAX technology, deliver the fast, responsive experience of a desktop application.
  • Managed appliances:
    • Managed configuration allows wireless, self-hunting, multiple modality operation. The site just turn on the appliance and Timaeus does the rest.
    • Broadband internet connections are not possible at many Investigator sites around the world, but Timaeus works anywhere that has at least partial mobile phone coverage. Timaeus seeks out 3G, GPRS or GSM signals and provides the same level of service — even when the network is down.
    • Portable and able to support multiple studies on a single appliance, including study updates, extensions, new studies etc.
    • Biometric fingerprint replaces password for access and digital signature. No more 'lost password' nightmares!
    • Ultra secure, virus immune and with the industry's leading firewall and encryption technology, Timaeus breeds confidence.
    • Direct capture of data from specific medical devices, e.g. vital signs, ECG, spirometers.
    • Saves time and money, and gives improved quality.
    • Barcode printing and scanning for tracking and management of source data, biological fluid samples etc.
    • Simple to use user interfaces with built in eCRF completion guidelines, help etc. Complexity removed from site's view.
    • Adaptive trial ready.

Fully-functional, sophisticated management capability

All you would expect from an enterprise clinical data management system, but updated, faster and easier to use.

  • Role-based user interface exposing only the functionality the user needs and is entitled to use.
  • Full medical coding functionality including dictionary management, auto-encoding, removal of special characters and stop words etc, use of synonyms.
  • Multiple blinding strategies.
  • Full laboratory data loading, error management, display to investigator sites, remote capture from laboratories, handling of normal and alert ranges etc.
  • e-loading of other data sources e.g. ECG, lab data
  • Within system data review, browsing, reporting, data group listing and sorting etc.
  • Full query management with automatic seamless management of paper and electronic queries in a hybrid trial.
  • All validation checks can fire on data entry or in batch validation mode or both.
  • Checks can be seen to fire on either eDC or eDM views or both.
  • Within-system audit-trailed QC Rapid data snapshots.
  • Simple point and click audit trailed exports to SAS, by individuals without programming skills.
  • CDISC ODM streaming output.
  • Ability to run entire system on a standalone appliance, meaning truly portable data management power and flexibility.
  • Flexible reporting using built in metrics of industry standard SQL tools.

Cmed has genuinely received quotes such as "truly awesome", "the best-kept secret in clinical research", "you have the holy grail".

Why not see for yourself? Request a demonstration of Timaeus today!