Checking the compliance of a study build to best practices and standards is often a manual task or requires SAS® programs to be run on an exported version of the study.
TrialGrid automates more than 65 best practice checks and can incorporate sponsor specific quality tests. Tests can be run at the push of a button ensuring that quality is built into the study build, not added at the end.
Finding deviations from standards and best practices is helpful but TrialGrid can do better. Where the change required is clear, TrialGrid offers a one-button fix. Click the button, problem solved, time saved.
For situations where the quality check isn't appropriate, enter an explanation. Once an issue has an explanation it will never be flagged in that study again. Explanations can be reviewed, approved or rejected as appropriate.
Standard Libraries allow organizations to reduce study build timelines but managing compliance through reviews and reporting is difficult.
TrialGrid tracks changes to study objects and compares them to their library standard versions and permitted deviations.
Forms, Data Dictionaries, Edit Checks and other objects which are not found in the Library or which do not match their Library definitions can be compared and differences explained by the study builder. Deviations can be approved or rejected by a Standards Manager and the entire workflow recorded.
Medidata Rave edit checks are powerful but the postfix syntax takes time and training to master. TrialGrid converts edit checks instantly between the Medidata Rave QuickEdit format and Clinical Query Language (CQL) an infix format that is simpler to learn, easier to read and quicker to write. What's more, the CQL editor provides code-completion features which speed the selection of data and functions to build edit checks faster.
Writing edit checks more quickly is only part of the story. Creating test cases for edit checks and executing them is time consuming. TrialGrid changes all that. Test scenarios are automatically populated as the edit check is written and can be run, and re-run, at the click of a button. With TrialGrid you don't have to track "needs retesting" because tests can be re-run at any time.
Study build is a team effort with many players and better communication leads to a better study build in faster time. TrialGrid includes collaborative features such as a shared file area and project wiki's as well as an activity stream that shows what changes have been made to the study build, when and by whom.