Advantages: Automated validation checking from beginning to end
Incorrect data lead to lost time and effort. Timaeus minimises the effects of incorrect data, from beginning to end, using a combination of automated validation checks and streamlined workflow processing.
One set of data, one set of checks
Timaeus provides unified management of both all clinical data and all validation checks in one system, from one configuration point.
At the start of a study, initial checks are implemented faster, as they only need to be programmed in one place. Later, when study designs change, they only need to be modified in one place. Finally, prior to database lock, there is no need to reconcile conflicts between the validation checks working across disparate EDC, CDM, coding and analysis systems and data sets.
Firing validation checks in real-time at the point of entry
Timaeus can fire all validation checks–for any visit or page, for any of its interfaces–in real time at the point of data entry. This detects problems immediately, enabling investigatory staff to make corrections when they are most focused on the patient's data. (Timaeus allows organisations to turn these off if they wish to apply them later, during data manager review.)
In addition, Timaeus automatically records a complete, versioned audit trail of data entered before firing the validation checks and after any resulting corrections. This assures 21 CFR Part 11 compliance.
Automating validation checks of third-party data
Timaeus not only provides edit checks for site-entered data, it does the same for all integrated third-party data—both batch and transactional data. Timaeus will flag third-party data that fail validation checks for downstream resolution.
Re-applying these benefits downstream
Timaeus’ automated validation checking does not end at data capture. The same checks applied at data capture are re-applied whenever needed: whenever trial designs are modified, whenever data are changed, during preparation for database lock, etc.
