Trials to be carefully designed before committing significant time and resources to actual trial execution.
Trial Guidance Methodology differentiates between the "step zero", where the gaps and the trial context are defined and the actual preparation step, where the trial objectives, research questions, data collection plan, approaches and metrics, and scenarios are formulated and the solutions selected.
Trial Guidance (TGT) supports the users in this phase by helping the users to define these elements in an interactive workflow with built-in error-checking and contextual help. In particular, TGT provides following useful features:
- A searchable list of "strategic gaps" that can be used "as is" in own trials, as well as the possibility to define additional "trial specific gaps".
- A list of suggested solutions for the trial. This list is automatically generated by automatically matching the "needs" of the trial (expressed through trial gaps) with the features that are offered by solutions from the Portfolio of Solutions.
- Validation function that assures the relations between the elements defined in this phase (gaps, objectives, research questions, data collection plan, scenarios and solutions) are well defined.
- Contextual help for all steps.