The preparation of each starts with defining the trial context, which refers to who, what, why and how. Within the GT, the very first step is to add a new "Trial Group" and invite the initial Trial Team to join this group. Trial Groups are virtual working spaces for organising trials. They allow the Trial Owner to organise a team and assign different roles and responsibilities to team members.

The starting point for designing the trial is to indicates which of the generic CM gaps the trial is going to address, followed by defining of the Trial Objectives, formulating the Research Questions, discovering and pre-assessing the potential solutions etc.. GT assures that this work proceeded in line with the TGM 6-step methodology, as illustrated below:

TGM defines this 6-step approach as iterative process, where steps in the process are iterated as many times as needed, until they reach the quality level that is deemed sufficient by the trial owners and their teams.